7
J ctin Periodomol 1996: 23: ST3-97S Printed in Dcnmarii . Alt rights reserved Copyright O Muittcsgaard 199i dliucal periDdoDtolDiur ISSN 0303-6979 Comparison of the plaque removal efficacy of a new flossing aid (Quik Floss®) to finger flossing Carter-Hanson C, Gadburv-Amyot C, Killoy W: Comparison of the plaque removal efficacy of a nev. flossing aid (Quik Ftoss^) to finger flossing. J Clin Periodontol 1996: 23: 873-878. © Munksgaard. 1996, Abstract. The purpose of this clinical trial was to compare the effectiveness and safety of a new dental flossing device (Quik Floss®) to finger flossing in plaque removal, reduction of gingival inflammation and patient preference, 30 healthy, non-flossing adults with 20 natural teeth, a plaque index (PI) of at least 1,8 and a gingival index (GI) of l.,l or greater participated in this two-phase crossover design study. Patients were randomly assigned to use either the new flossing device or finger flossing first in the sequence. At baseline, data were collected and patients were given flossing method instructions. The Silness & Loe Gl, Quigley- Hein PI. Eastman Bleeding Index (BI) and trauma were assessed at baseline. 15 and 30 days for each treatment period. After the initial 30-day treatment phase, patients were instructed to cease all flossing during a 14-day "washout" period. Subjects were then assigned to the opposite treatment group during the 2nd treatment phase, A 3-factor repeated measures ANOVA analyzed data for differ- ences within and between groups over time. Results revealed statistically significant (/i<0,01) within group improvement in PI, Gl. and BI for both treatment groups over time. No statistically significant between group differences were found for either group at any time period. In addition, no significant gingival trauma was recorded and no differences were found between groups, Quik Floss® was as effective as finger flossing. Subjects preferred (55'V,,) Quik Floss® over finger floss- ing. In conclusion. Quik Floss® is a safe and effective oral hygiene measure for reducing plaque, inflammation and bleeding over time. Carrie Carter-Hanson, Cynthia Gadbury-Amyot and Wiiliam Killoy University of Missouri-Kansas Ctty, School of Dentistry. Kansas, tJSA Key words: flossing aid: finger flossing: dental plaque: gingival inflammation: clinical indices Accepted for publication 16 December 1996 It has been established that gingivitis, periodontal disease and dental caries are initiated by the colonization and ac- cumulation of bacterial plaque (Loe et al. 1965, Newbrun 1969, Socransky 1970, Fehr et al, 1970. and Slots & Listgarten 1988). Plaque removal ulti- mately leads to the reduction of the se- verity of oral disease (Ash et al, 1964, Lindhe & Koch 1967, Loe 1969. Soumi 1971), Utilizing a toothbrush to mech- anically remove plaque is extremely ef- fective (Lindhe & Koch 1967. Hansen & Gjermo 1971, Sagnes et al, 1972, Lang et al, 1973. O'Leary 1984). yet is not capable of thorough plaque removal when used alone (Lindhe & Koch 1967, Hansen & Gjermo 1971. Sagnes et al 1972), Research shows that a combi- nation of both supra and sub-gingival plaque removal is important in reducing the onset and severity of gingival dis- ease (Carter, et al. 1971. Bergenholtz & Britton 1980). Routine use of dental floss has been found to be astonishingly low (Spolsky et al, 1983, Gift 1986), Only 1 y'A< of adults and S-^Vo to eight percent of youth were reported to use floss regularly on a daily basis (Gift 1986), The primary problem associated with flossing is with the patient's in- ability to perform flossing on a regular basis as part of daily oral hygiene (Kresh 1976), Therefore, the aim of dental research in this arena should fo- cus on increasing people's ability to es- tablish a regular flossing habit. Explor- ing ways to make flossing a regular part of home care by the use of flossing aids is one technique (Spolsky et al, 1993, Gift 1986), Few clinical trials com- paring floss aids to finger flossing have been conducted to date (Barton & Dia- mond 1980. Mulligan & Wilson 1984. Rich et al, 1989, Spolsky, 1993), Spolsky et al, (1993) compared the efficacy of a flossing aid (Flosser® by Oral-B) to conventional finger flossing.

Comparison of the plaque removal efficacy of a new flossing aid (Quik Floss®) to finger flossing

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Page 1: Comparison of the plaque removal efficacy of a new flossing aid (Quik Floss®) to finger flossing

J ctin Periodomol 1996: 23: ST3-97SPrinted in Dcnmarii . Alt rights reserved

Copyright O Muittcsgaard 199i

dliucal periDdoDtolDiurISSN 0303-6979

Comparison of the plaqueremoval efficacy of a new flossingaid (Quik Floss®) to fingerflossingCarter-Hanson C, Gadburv-Amyot C, Killoy W: Comparison of the plaque removalefficacy of a nev. flossing aid (Quik Ftoss^) to finger flossing. J Clin Periodontol1996: 23: 873-878. © Munksgaard. 1996,

Abstract. The purpose of this clinical trial was to compare the effectiveness andsafety of a new dental flossing device (Quik Floss®) to finger flossing in plaqueremoval, reduction of gingival inflammation and patient preference, 30 healthy,non-flossing adults with 20 natural teeth, a plaque index (PI) of at least 1,8 and agingival index (GI) of l.,l or greater participated in this two-phase crossoverdesign study. Patients were randomly assigned to use either the new flossingdevice or finger flossing first in the sequence. At baseline, data were collected andpatients were given flossing method instructions. The Silness & Loe Gl, Quigley-Hein PI. Eastman Bleeding Index (BI) and trauma were assessed at baseline. 15and 30 days for each treatment period. After the initial 30-day treatment phase,patients were instructed to cease all flossing during a 14-day "washout" period.Subjects were then assigned to the opposite treatment group during the 2ndtreatment phase, A 3-factor repeated measures ANOVA analyzed data for differ-ences within and between groups over time. Results revealed statistically significant(/i<0,01) within group improvement in PI, Gl. and BI for both treatment groupsover time. No statistically significant between group differences were found foreither group at any time period. In addition, no significant gingival trauma wasrecorded and no differences were found between groups, Quik Floss® was aseffective as finger flossing. Subjects preferred (55'V,,) Quik Floss® over finger floss-ing. In conclusion. Quik Floss® is a safe and effective oral hygiene measure forreducing plaque, inflammation and bleeding over time.

Carrie Carter-Hanson,Cynthia Gadbury-Amyot andWiiliam KilloyUniversity of Missouri-Kansas Ctty, School ofDentistry. Kansas, tJSA

Key words: flossing aid: finger flossing: dentalplaque: gingival inflammation: clinical indices

Accepted for publication 16 December 1996

It has been established that gingivitis,periodontal disease and dental cariesare initiated by the colonization and ac-cumulation of bacterial plaque (Loe etal. 1965, Newbrun 1969, Socransky1970, Fehr et al, 1970. and Slots &Listgarten 1988). Plaque removal ulti-mately leads to the reduction of the se-verity of oral disease (Ash et al, 1964,Lindhe & Koch 1967, Loe 1969. Soumi1971), Utilizing a toothbrush to mech-anically remove plaque is extremely ef-fective (Lindhe & Koch 1967. Hansen &Gjermo 1971, Sagnes et al, 1972, Langet al, 1973. O'Leary 1984). yet is notcapable of thorough plaque removal

when used alone (Lindhe & Koch 1967,Hansen & Gjermo 1971. Sagnes et al1972), Research shows that a combi-nation of both supra and sub-gingivalplaque removal is important in reducingthe onset and severity of gingival dis-ease (Carter, et al. 1971. Bergenholtz &Britton 1980). Routine use of dentalfloss has been found to be astonishinglylow (Spolsky et al, 1983, Gift 1986),Only 1 y'A< of adults and S-^Vo to eightpercent of youth were reported to usefloss regularly on a daily basis (Gift1986), The primary problem associatedwith flossing is with the patient's in-ability to perform flossing on a regular

basis as part of daily oral hygiene(Kresh 1976), Therefore, the aim ofdental research in this arena should fo-cus on increasing people's ability to es-tablish a regular flossing habit. Explor-ing ways to make flossing a regular partof home care by the use of flossing aidsis one technique (Spolsky et al, 1993,Gift 1986), Few clinical trials com-paring floss aids to finger flossing havebeen conducted to date (Barton & Dia-mond 1980. Mulligan & Wilson 1984.Rich et al, 1989, Spolsky, 1993),

Spolsky et al, (1993) compared theefficacy of a flossing aid (Flosser® byOral-B) to conventional finger flossing.

Page 2: Comparison of the plaque removal efficacy of a new flossing aid (Quik Floss®) to finger flossing

874 Carter-Hanson et al.

Their study found no statistically sig-nificant between group differences ingingival inflammation and plaque.However; patients preferred (56"/n) theflossing aid slightly over finger flossing.

Barton & Diamond (1980) comparedconventional finger flossing to a flossholder (EZ Dental Flosser® by Preven-tive Dentistry Products. Inc) in a popu-lation of 67 active duty or retired mili-tary members and their dependents.Both flossing methods were found to beequal in reducing inflammation. Ad-ditionally, the mechanical floss aid waspreferred by a ratio of 4:3,

As with Spolsky et al. (1993), a studyconducted by Mulligan & Wilson(1984) evaluated the patient's percep-tion of design and characteristics of 8commercially available floss holding de-vices, A control group of 11 personswith manual dexterity difficulties wascompared to a group of 20 people with-out dexterity problems, A 5-point Li-kert scale instrument revealed one ofthe 8 floss aids (Floss aid® by Stam Co,)was preferred. It was ranked 1st or 2ndon design and ease of use by all partici-pants.

In contrast. Rich et al, (1980) as-sessed the effects of three flossingmethods in 3rd grade children. The useof a floss holder (EZ Fiossholder by E-Z Floss Co,), looped floss (Flossloop*by Dental Preventech Corp,) and con-ventional finger flossing was comparedas an adjunct to toothbrushing and totoothbrushing alone. Results revealedthe floss holder group to have the leastimproved plaque scores when comparedto brushing only. After a 4-week period,the finger flossing method resulted inthe most improved GI scores.

Therefore, the purpose of this ciinicaltrial was to evaluate the plaque removalefficacy, patient satisfaction and safetyof a new flossing device (Quik Floss®by U,S. Floss, Inc) compared to con-ventional finger flossing in patients whodid not routinely use dental floss. Noclinical trials have been conducted todate comparing Quik Floss* to othercommercially marketed floss products,A dual treatment, examiner blind,crossover design was utilized to ac-complish this trial.

Material and MethodsSubject criteria

Adults 18 years or older who did notperform flossing on a daily basis weresolicited through advertisement at the

University of Missouri-Kansas CitySchool of Dentistry newspaper (CrownCrier) as well as through television me-dia in the Kansas City metropolitanarea.

Study qualification was determinedat an initial screening appointment util-izing the following inclusion criteria:presence of at least 20 natural teeth (ex-cluding 3rd molars): a medical historyfree of the need for antibiotic prophy-lactic pre-medication, hormonal ther-apy, steroids, or use of non-steroidalanti-inflammatory drug therapy withinthe previous month; a medical historyfree of diabetes mellitus. hepatitis, orpregnancy; no manual dexterity limi-tations; and availability for a 10 weekstudy period. In addition, each partici-pant exhibited a plaque score of 1.8 orgreater on the Turesky modification ofthe Quigley-Hein plaque index (PI) (Tu-resky 1970) and a minimal score of 1,3or greater on the Loe & Silness (1963)gingival index.

Subjects were excluded from study ifthey had received a preventive oralprophylaxis within the previous month;had a history of dental flossing one ormore times per day on a regular basis;had gross dental caries and/or oral hy-giene neglect; exhibited advanced peri-odontitis (periodontal pockets a 6 mm);or had received active periodonta! ther-apy within the previous 6 weeks. Thisstudy was approved by the InstitutionalReview Board at the University of Mis-souri-Kansas City Informed consentwas obtained in writing by ail partici-pants before the onset of study.

Sample size and study design

A sample size of 30 was determinedusing a calculation modeled after Spol-sky et al, (1993), A 2-phase, examinerblind, crossover design was employedin which all subjects received bothtreatments in a randomized order.Each treatment period consisted of 30days use of the assigned product witha 14-day "washout" period betweentreatments. During the "washout"period subjects were instructed to re-sume their regular oral hygiene prac-tices (no flossing) and were asked toreturn any unused floss product. The"washout" period gave patients time toreturn to their previous oral status andestablish baseline clinical measure-ments prior to receiving the secondfloss product. Additionally, the cross-

over design made it possible to utilize50̂ /11 fewer subjects.

Methods and examination sequence

Clinical examinations were performed atbaseline, 15 and 30 days of each treat-ment period. Sequencing of the clinicalexamination consisted of the PI, Bl, andGl consecutively. This particular se-quencing was chosen in order to elimin-ate possible removal of plaque by eitherthe Eastman bleeding index (BI) (Ca-ton & Poison 1985) or the Loe & Siiness(1963) gingival index prior to plaque as-sessment. In addition to these indices,gingival trauma was assessed to establishand demonstrate safety of the new floss-ing aid. Clinical indices utilized are wide-ly accepted in the literature as valid andrehable measures (Ciancio 1986).

Plaque, inflammation,, bleeding andtrauma were assessed by the principalinvestigator and a co-investigator. Bothinvestigators were registered dental hy-gienists with more than 10 years of clin-ical experience. Before and during theclinical trial, both intra-and inter-raterreliability was established. Reliabilitydata is included in the results section.

To ensure investigator blindness, oralhygiene instruction on conventionalfinger fiossing and use of the experi-mental floss aid was conducted by othertrained members of the clinical and ap-plied research department at the Uni-versity of Missouri-Kansas City Schoolof Dentistry, using a standardized set ofinstructions, instructions were givenafter completion of clinical assessmentswhen principal and co-investigators hadvacated the operatory premises.

Each tooth in the mouth was exam-ined at the mesial and distal (interproxi-mal) surfaces, both facially and hn-gually for plaque and gingival health.The Eastman bleeding index was as-sessed on facial surfaces only. The ap-piication of a red disclosing solution(Red Cote* by Butler®) was used to aidin identifying the location and amountof plaque present, A stimudent (Sti-mudent interdental Cleaner* by lohn-son & Johnson Dental Care Co,) wasused to assess bleeding as outlined inthe Eastman bleeding index. Trauma in-duced by improper flossing was also as-sessed at each appointment using a mir-ror, air and light. All interproximal as-pects of the facial and lingual surfaceswere examined for gingival lacerations,identified trauma was scored as a one(1). indicating the presence of a floss cut

Page 3: Comparison of the plaque removal efficacy of a new flossing aid (Quik Floss®) to finger flossing

Plaque retnoval and Quik Eloss'^ 875

or demarcation line at that site, A scoreof zero (0) was recorded if no traumawas present.

At each baseline appointment, forboth treatment phases, patients receivedtheir assigned floss products. Subjectsassigned to finger flossing were given40, individual, 18 inch pieces of unwax-ed floss (Johnson & Johnson* unwaxedfloss) of an 840 denure. Subjects as-signed to the floss aid received 1 bag of40 individual floss aides (Quik Floss*by U. S, Floss, Inc) containing unwax-ed floss of the same 840 denure. Sub-jects also received a toothbrush (Oral-B* 35 by Oral-B Laboratories),

Patient compliance

Patient compliance with the use of bothfloss products was derived from compli-ance calendars and returned flossingmaterials. Subjects were asked to recordeach flossing performance on their cal-endar. Compliance calendars weregiven to subjects at the baseline ap-pointment of each treatment phase andwere collected at the end of each 30-dayperiod. Compliance was further estab-lished by dispensing a specific amountof floss product at the onset of eachtreatment phase. At the conclusion ofeach 30-day interval, patients wereasked to return any unused portion offloss product. In addition, the patientsatisfaction questionnaire served tosubstantiate the number of times a pa-tient flossed and the amount of productused throughout the study.

ResultsAge and gender

30 people met the criteria for partici-pation in the study. One subjectdropped out before completion of thestudy due to unavailability for appoint-ments. All of the clinical data presentedis based on the 29 subjects who success-

Tablc 2. Mean scores for plaque index, gingival index, bleeding index, and traunJa index:mean scores and standard deviations at baseline, 15 day and 30 day exams

Index/Group

Plaque indexFinger FlossOuik Floss"

Gingival indexFinger FlossQuik Floss*

Bleeding indexFinger FlossQuik Floss*

Trauma indexFinger FlossQuik Floss*

Baseline mean (SD)

2,59 (±0,54)2.65 (±(.1.41)

1.60 (±0.31)1.59 (±0.31)

0.55 (±0.23)0.59 (±0.28)

0.00 (±0.00)0.00 (±0,00)

15 day mean {SD)

2.07 (±0.53)*1.95 (±0.48)*

1.31 (±0.24)*I.3I (±0.21)*

0.31 (±0.21)*0.31 (±0.20)*

0.01 (±0.01)0.00 (±0.01)

30 day mean (SD)

1.87 (±0.39)*1.85 (±0.50)*

1.30 (±0.20)*1.28 (±0.18)*

0.30 (±0 19)*0.27 (±0.17)*

0.00 (±0.01)0.00 (±0.01)

' Statistically significant (p<O.OI) from baseline to 15 days and baseline to 30 days.

fully completed both treatment phasesof the study.

Subjects age, gender and treatmentgroups appear in Table L 22 (76"/i) ofthe participants were female and 7[lA"At) were male. The average age was39,1 (±10,5) years with a range of 22-58 years. In the 1st phase, 15 subjectsused finger flossing and 14 subjects usedQuik Floss® In the 2nd phase, after the14-day "washout", 14 subjects usedfinger floss and 15 subjects used QuikFloss®.

Clinical indices

In a randomized cross-over design trialthe potential of sequence being a sig-nificant variable is always of concern, A14-day "washout" period was im-plemented in this study to minimize thispossibility. In order to determinewhether randomized sequence of prod-uct was a significant factor, a 3-factoranalysis of variance (ANOVA) was con-ducted to exatnine the main effects oftime, floss group and sequence of prod-uct use. The analysis showed no maineffect of sequence. Since sequence wasnot a significant factor, data were ana-

Table 1. Age, gender and

Group

Phase IQuik Floss"

toFinger Floss

Phase IIFinger Floss

toQuik Floss®

totals

subjects m

Number

14

15

15

14

« = 58

1 reatment groups

Males ("•;.)

5

2

2

5

24%

Females ('/'»)

9

13

13

9

76"AI

Mean age (SD)

39,1 (±10,5)

39.1 (±10.5)

39.1 (±10.5)

lyzed using a 2-factor repeated meas-ures ANOVA.

Baseline mean scores for plaque, in-flammation and bleeding indices forboth treatment groups are shown inTable 2, There were no significant dif-ferences between the groups. Baselinescores for both groups and at eachtreatment phase were similar.

The mean scores at 15-and 30-day in-tervals for plaque, gingival and bleed-ing indices are also shown in Table 3,Analysis of variance yielded significant(/)<0,01) decreases in both groups forplaque, gingival inflammation andbleeding indices. There were no signifi-cant findings between groups at any in-terval for any clinical measure. BothQuik Floss® and conventional fingerfloss resulted in improved plaque, in-flammation and bleeding over the studyperiod.

The Fisher-Hayter Post Hoc tech-nique was used to determine the criticalmean difference (CMD) for withingroup effects for specific intervals.Mean differences and CMD criterionfor plaque, gingival and bleeding indi-ces are presented in Table 3, In orderto be statistically significant, the meandifference between clinical scores aleach interval must equal or exceed theCMD, Plaque, inflammation and bleed-ing for both treatment groups showed asignificant (p<0,01) improvement frombaseline to 15 days and from baselineto 30 days. Although indices continuedto improve over time, no significant dif-ferences were found between 15 and 30days for either group.

Trauma was also assessed at eachinterval to establish and determine thesafety of Quik Floss® No significanttrauma was recorded and no differ-

Page 4: Comparison of the plaque removal efficacy of a new flossing aid (Quik Floss®) to finger flossing

876 Carter-Hatison et al.

Table 3. Critical mean differences and meanbleeding index within groups: baseline, 15-dav

Index/treatmentgroup

Plaque indexFinger FlossQuik Floss*

Gingival indexFinger FlossQuik Floss®

Bleeding indexFinger FlossQuik Floss*

CMD

0,220,22

0,120,12

0,120,12

differences for plaque index.and 30-day exams

Baseline - 15 days Baseline - 30 days

0,62*0,70*

0,29*0,28*

0,14*0,29*

0,81*0,80*

0,,30*0,30*

0,15*0,32*

gingival index.

15-30 days

0,20 n/s0,10 n/s

0,01 n/s0,03 n/s

0,01 n/s0,04 n/s

* Statistically significant (/?<0,01) at that specific interval,n/s: not statistically significant.

Table 4. Selected questions patient satisfaction/ marketing questionnaire administered at con-clusion of the final treatment phase: ntmiber and % of responses

Questions and specific responses No. and "i\; of responses

(1) Since the study began, how often do you nowfloss?(Fill in the blank)3Xperweek 1/29=3,4%5Xper week 2/29=6,8%6Xperweek 2/29=6,8%7Xor greater per week 24/29=82,7%

(2) if Quik Floss* were available in the store,would you purchase it?Definitely or probably Would 17/29=68,9%Possibly would 2/29=7%Probably not 5/29=17%Definitely not 5/29=17%

(31 List ! or 2 features you liked most aboutQuik Floss*

Easy 10 use, quick, convenientPerfect size, or easy to floss back teeth

(4) Qf the 2 flossing methods used in this study(Quik Floss and Finger Flossing), which onedid you prefer?Quik Floss® 16/29=55%Finger Floss 13/29=45'%

ences were found between the groups,Quik Floss® was foutid to be as safeas finger flossing. The mean scores forboth floss products are also presentedin Table 2, Mean scores for fingerflossing and Quik Floss*^ were 0,00(±0,01) and 0,01 (±0,00) at the 30-dayinterval.

Calibration of examiners was alsodetertnined as a statistical result of thisstudy. Examiner reliability was as-sessed to ensure plaque and gingiva!index measurement consistency be-tween and within the two examiners.Calibration on bleeding was not con-ducted due to the nature of the indexitself. The BI is scored as either a zero(0) or one (I) describing the presenceor absence of bleeding after the inser-tion of a interdental wood cleaner.

Conducting a second examination forcalibration would induce further bleed-ing and invalidate the index. Corre-lation coefficients for both inter-rater(0,66) and intra-rater (0,81) reliabilitywere established. The K score was cal-culated to be 0,74,

Questionnaire

Patient ComplianceQuestions in the patient satisfactionquestionnaire were designed to sub-stantiate the information received frompatient calendars. In terms of flossingfrequency, patients were asked howoften they flossed since the start of thestudy, 83% of patients reported floss-ing a:7Xper week, whereas only 17%reported flossing s 6 x p e r week, re-

gardless of which floss product wasused (Table 4), Although patient calen-dars were a crude measure of patientcompliance during the study, datafrom the questionnaire correspondedwith the data collected from the calen-dars and unused, returned floss prod-uct, Al! patients returned their compli-ance calendars and indicated flossingone time per day by placing a checkmark (̂ ) on each day of the calendar.

Patient satisfactionSpecific questions dealt with patientsatisfaction of product, A summary ofthese questions are presented in Table4, which includes the number and per-cent of responses. Using a LikertScale, patients responded to a questionasking if they would purchase QuikFloss® if available. Responses indi-cated that 68,9% definitely or probablywould purchase the product. Likewise.an open-ended question targetmg theunique and positive features of QuikFloss® was reflected in statements suchas it was "easy to use", "quick andconvenient" or "perfect size" and"easy to floss the back teeth". Afterusing both flossing products. 16 (55%)of subjects demonstrated a preferencefor Quik Floss* compared to 13 (45%)who preferred finger flossing. The dif-ferences were not statistically signifi-cant.

Discussion

Dental floss is still the most effectivemeans we have to date for removing sub-gingival interproximal dental plaque,(Finkelstein & Grossman 1979, Bergen-holtz & Bnthon 1980, Lobene et al,1982). Unfortunately, most people donot use dental floss routinely (Kresh1976. Spolsky etal, 1983, Gift 1986) sug-gesting the need for alternative flossingmethods. This study indicates the abilityof Quik Floss* disposable floss aids toremove plaque, decrease inflammationand bieeding as well as finger flossingwhen compared in a 74- day clinica! trial.In addition, data regarding patient pref-erence showed a tendency towards thefloss-aid.

Results of the current investigationare in agreement with previous studieswhich have compared mechanical floss-ing devices to conventional finger floss-ing. The majority of these studies dem-onstrate no additional clinical advan-tage, however results show floss devicesdo reduce clinical indices and are gener-

Page 5: Comparison of the plaque removal efficacy of a new flossing aid (Quik Floss®) to finger flossing

Plague removal and Quik 877

ally preferred by patients for flossing(Barton & Diamond 1980, Mulligan &Wilson 1984, Spolsky, et al, 1993). Pref-erence for this type of floss productcould increase a patient's ability to in-corporate flossing into their daily oralcare routine.

ln this study, patients had a moder-ate amount of plaque, inflammationand bleeding as evidenced by their base-line scores. Patients of the current studywere representative of most patientssince most patients do not floss (Spol-sky et al. 1983). ln addition, patientsexhibited early signs of gingival diseasebut no advanced periodontitis as re-commended by Kleisner & Infeld(1993). Since the sample was reflectiveof a standard population of relativelyhealthy individuals with gingivitis, re-sults are generalizable.

Patient compliance

For a group of subjects who did not pre-viously floss on a regular basis, the infor-mation obtained from the questionnaireand compliance calendars suggests sub-jects demonstrated compliance withboth flossing products during the dur-ation of the study period. However, com-pliance demonstrated in a 30-day cross-over clinical trial can be mostly attri-buted to the effect of testing. This findingis also in agreement with previousstudies (Spolsky et al. 1993),

Proper flossing instruction of bothproducts at the onset of each treatmentphase was also a critical component inthe evaluation and elimination oftrauma during study. An ora! assessmentperformed at 15 and 30 days for eachtreatment period found trauma to beminimal in both groups (Table 2), sug-gesting Quik Floss* be used safely bynon-flossers. With any flossing method,instruction on proper technique is vitalto the reduction of lacerations inducedby the flossing technique.

In conclusion, this clinical trial coin-paring the efficacy and safety of QuikFloss** to conventional finger flossingindicates Quik Floss® to be a safe andeffective alternative plaque removal aid.It was found to be comparable to fingerflossing in the reduction of plaque, in-flammation and bleeding over a 60-dayperiod. In combination with the patientpreference and positive comments, QuikFloss® would be a viable alternative toconventional finger flossing in helpingpatients establish regular flossinghabits.

Acknowledgements

The authors would also like to ac-knowledge Daniel Tira, and Karen B.Williams, for their statistical consul-tation.

Zusammenfassung

Effektivitdtsvergieich zwischen der Zahnrei-ningung mit Zahmeide und Haherung i QuickFlo.s,';^) und der Zahnreinigung mit Zahn.'ieideund FingersteuerungDer Zweck der vorliegenden Studie war es,die Effektivitat und Sicherheit der Zahnrei-nigung mit einer neuen HaUerung fur Zahn-seide (Quick Floss*), gegenuber der Finger-steuerung der Zahnseide ohne Halterungs-hilfe zu ermitteln und zwar hinsichtlich derPlaqueenffernung, der Reduktion der Gingi-vaentziindung und, bei Wahlmoglichkeit,der subjektiven Praferenz einer der beidenReinigungsarten. An dieser zwei-phasigenCrossover Studie nahmen 30 gesunde Er-wachsene teil, die Ihre Zahne nicht mitZahnseide reinigten, bei denen 20 natUrlicheZahne vorhanden waren und bei denen einPlaqueindex (PI) von minstestens 1.8 undein Gingivaindex (GI) von 1.3 oder hohervorlag. Dem Zufalligkeitsprinzip folgend,wurden die Patienten beauftragt, entwederdie neue Halterung ftir Zahnseide oder dieFingersteuerung der Zahnseide im Versuchs-verlauf zuerst anzuwenden. Emgangs wur-den Daten gesammelt und die Patientenuber Reinigungsmethoden mit der Zahnsei-de belehrt. Der GI nach Silness & Loe, derPI nach Quigley-Hein, der BlutungsindexBach Eastmann (BI) und vorhandene Trau-mata wurden in jeder Behandlungsperiodebei der Ausgangssituation und nach 15 und30 Tagen beslimmt. Nach der initialen, 30Tage andauernden Behandiungsphase, wur-den die Patienlen angewiesen, die Reinigungmit der Zahnseide wahrend einer 14 Tagelangen "wash-out" (Ruhe-) Periode einzu-stellen. WShrend der zweiten Behand-lungspiiase wurden die Versuchspersonender entgegengesetzten Behandlungsgruppezugeteilt. Die, nach 3-faktoriell wiederholtenMessungen mit ANOVA analysierten, DatenprUften, inwieweit wahrend dieser Zeit tn-nerhalb der, und zwischen den, GruppenDifferenzen vorlagen. Die Ergebnisse zeig-ten bei beiden Behandlungsgruppen, daCsich in dieser Zeit die P1-, GI- und Bl-Werteinnerhalb der Gruppen statistisch signifi-kant (/i<0.01) verbesserten. Anzeichen stati-stisch abgesicherter Unterschiede zwischenden Gruppen wurden bei keiner Gruppe zuirgendeiner Zeit gefunden. Zusatziich wirderwahnt, daB kein gingivales Trauma regi-striert wurde. Hierbei bestand kein Unter-schied zwischen den Gruppen. Quick Floss®war genauso effektiv wie die mit Fingerngesteuerte Zahnseide. 55'!'i der Versuchsper-sonen zogen Quick Floss* der mit Fingerngesteuerten Zahn,seide vor Es wird gefol-gert, daB Quick Floss* ein sicheres und ef-

fektives Mundhygienemitte! zum Erreichender Reduktion von Plaque, Entzlindung undBlutung (jber die Versuchsdauer ist.

Resume

Efficacite du Quik Floss"" par rapport a I'uti-li.'iation classique du fil dentaireLe but de cet essai clinique a ete de compa-rer Tefficacite et la surete d'un nouvelinstrument permettant le nettoyage dentairepar le fil (Quik Floss'*) vis-a-vis du nettoya-ge dentaire par le fil en utilisant les doigts,et ceci tant pour la reduction de la plaquedentaire que poar celle de I'infiammationgingivale. Trente patients adultes sains n'uti-lisant pas le fil dentaire et possedant 20dents naturelles, un indice de plaque d'aumoms 1,8 et un indice gingival d'au moins1,3 ont participe a cette etude croisee endeux phases. Les patients ont ete repartis auhasard en deux groupes et utilisaient le fildentaire soit avec les doigts soit avec leQuik Floss*. Lors de I'examen de depart lesdonnees ont ete enregistrees et les patientsoni rei;u les instructions en nettoyage par fildentaire. L'indice gingival de Loe & Silness,rindice de plaque Quigley-Hein, I'indice desaignement de Eastman et le traumatismeont ete enregistres lors de 1 examen initial,et apres 15 et 30 jours pour chaque periodede traitement. Apres une phase initiate detraitement de 30 jours, les patients ont etepries de cesser tout nettoyage par fil dentai-re durant une periode intermediaire de 14jours. Les sujets ont ensuite du utiliser I'au-tre mode de traitement durant la secondephase de cette etude. L analyse par ANOVAdes mesures repietees par trois facteurs pourles differences intra- et inter-groupes a eteutilisee pour l'analyse longitudinale. Les re-sultats ont revele des differences significati-ves (/lO.Ol) intra-groupes avec des amelio-rations des PI, GI el BI. .Aucune differenceinter-groupes n a ete trouvee a aucun mo-ment de Fexamen. De plus, aucun trauma-tisme gingival n"a ete enregistre et done au-cune difference n'a ete trouvee entre iesgroupes. Le Quik Floss* s'avere done aussielTectif que le nettoyage classique par ii]dentaire. Les sujets preferaient (55%)le QuikFloss® au nettoyage par fll dentaire. LeQuik Floss* est done un systeme sur et ef-ficace permettant une bonne hygiene buc-cale.

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Address:

Carrie Carier-HansonCommunity DentistryVMKC School of Dentistry650 East 25th StreetKansas Citv. MO 64108USA

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