RCT: The Effectiveness of Brushing and Flossing Sequence on Control of Plaque and Gingival Inflammation

• Sponsor: Melaka Manipal Medical College (Other)
• Overall Status: Completed
• CT.gov ID: NCT03989427
• Collaborator: Colgate Palmolive (Industry)
• Enrollment: 30
• Location: 1
• Arms: 2
• Actual Duration (Months): 8
• Patients Per Site Per Month: 3.7

Study Details

Study Description

Brief Summary

This study evaluates the effectiveness of brushing and flossing sequence in the control of dental plaque and gingival inflammation.

Condition or Disease	Intervention/Treatment	Phase
Gingival Inflammation; Plaque; Gingival Bleeding; Plaque Control	Other: Brushing first and Flossing later (BF); Other: Flossing first and Brushing later (FB)	N/A

Detailed Description

Periodontal disease is the disease of the supporting dental tissues like alveolar bone,periodontal ligament cementum and gingiva. The most common form is plaque-induced gingivitis . Bleeding on gingival probing is one of the hallmarks of gingival inflammation.The removal of dental plaque is the most crucial action for preventing and treating gingival inflammation. Toothbrush along with toothpaste are still the most reliable means of plaque control. However, cleaning should be thorough and performed at regular intervals.

Toothbrush has a limited ability to reach all the areas around the tooth. Inter-dental areas are prone for plaque accumulation and gingival inflammation. Dental floss is one of the most effective tool in addition to tooth brush to remove inter-dental plaque. The sequence of using toothbrush and dental floss may influence the removal of dental plaque and consequently reducing the bleeding on probing of gingiva. There is conflicting evidence in the literature. The hypothesis of this study is that the sequence of brushing and flossing will not influence control of plaque control and gingival inflammation.

Study Design

• Study Type: Interventional
• Actual Enrollment: 30 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Intervention Model Description: Participants will be selected by random sampling and allocated to Two Arms: Arm-I - Brushing first and Flossing later (BF), Arm II- Flossing first and brushing later (FB) after applying inclusion and exclusion criteria. The participants in BF group will Brush first using Colgate® tooth brush for a 2-week period. and then floss with Colgate® dental floss using Spool method for a 2-week period. This is followed by a one week wash out period After this cross over is done in which participants will change the sequence to FB wherein they will floss first and brush later. The participants in FB group will floss first with Colgate® dental floss and brush later using Colgate® tooth brush for a 2-week period. This is followed by a one week wash out period. After this cross over is done in which participants will change the sequence to BF wherein they will Brush first and Floss later.Participants will be selected by random sampling and allocated to Two Arms: Arm-I - Brushing first and Flossing later (BF), Arm II- Flossing first and brushing later (FB) after applying inclusion and exclusion criteria. The participants in BF group will Brush first using Colgate® tooth brush for a 2-week period. and then floss with Colgate® dental floss using Spool method for a 2-week period. This is followed by a one week wash out period After this cross over is done in which participants will change the sequence to FB wherein they will floss first and brush later. The participants in FB group will floss first with Colgate® dental floss and brush later using Colgate® tooth brush for a 2-week period. This is followed by a one week wash out period. After this cross over is done in which participants will change the sequence to BF wherein they will Brush first and Floss later.
• Masking: Single (Outcomes Assessor)
• Masking Description: The outcome assessor will record measurements at baseline and post intervention. The assessor will be blinded from the sequence of intervention allocation.
• Primary Purpose: Prevention
• Official Title: The Effectiveness of Brushing and Flossing Sequence on Control of Plaque and Gingival Inflammation-A Randomized Controlled Clinical Trial in Klinik Pergigian, MMMC, Melaka
• Actual Study Start Date: May 20, 2019
• Actual Primary Completion Date: Dec 15, 2019
• Actual Study Completion Date: Jan 20, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Brushing First and Flossing Later (BF) The participants in BF group were asked to use modified bass method of tooth brushing first using Colgate® tooth brush (the amount of Colgate® tooth paste used is half-length of the toothbrush's head) and then floss with Colgate® dental floss using Spool method for a 2-week period. This is followed by a one week wash out period wherein they will practice oral hygiene according to their habitual method. After this cross over is done in which participants will change the sequence to FB wherein they will floss first and brush later.	Other: Brushing first and Flossing later (BF); Participants will follow Brushing first and flossing later (BF) sequence for 2 weeks, and after 1 week wash out period, Flossing first and Brushing later (FB) sequence for another 2 weeks.; Other Names: Colgate® tooth brush and Colgate® Dental Floss
Experimental: Flossing First and Brushing Later (FB) The participants in FB group were asked to floss first with Colgate® dental floss using Spool method and then modified bass method of tooth brushing first using Colgate® tooth brush (the amount of Colgate® tooth paste used is half-length of the toothbrush's head) for a 2-week period. This is followed by a one week wash out period wherein they will practice oral hygiene according to their habitual method. After this cross over is done in which participants will change the sequence to BF wherein they will brush first and floss later.	Other: Flossing first and Brushing later (FB); Participants will follow Flossing first and Brushing later (FB) sequence for 2 weeks, and after 1 week wash out period, Brushing first and flossing later (BF) sequence for another 2 weeks.; Other Names: Colgate® tooth brush and Colgate® Dental Floss

Outcome Measures

Primary Outcome Measures

1. Change From Baseline in Mean BPI Index Scores at 2 Weeks [Baseline and 2 weeks]

   Bleeding on probing (BOP) is an objective indicator of inflammation. BPI (Bleeding Point Index) is a validated index used to measure BOP. BOP is determined at the buccal, lingual and proximal surfaces of all teeth using BPI scores. BPI scores are measured at baseline and 2 weeks, followed by a wash out period of one week. BPI score is measured again at baseline and 2 weeks after cross over in intervention. Change in BPI scores will give the estimation of effect of the intervention. BPI score- minimum value is 0% and Maximum is 100% of bleeding surfaces in each individual patient with teeth. A positive error means that the predicted value is larger than the true value, and a negative error means that the predicted value is less than the true value. The mean error should be close to zero. Sometimes it will be negative or positive depending on the population.. Higher mean score is poor outcome. However, higher reduction in mean score compared to baseline is better outcome.

Secondary Outcome Measures

1. Change From Baseline in Mean RMNPI Index Score at 2 Weeks [Baseline and 2 weeks]

   Rustogi Modified Navy Plaque Index(RMNPI) is a self validated tool to assess dental plaque accumulation on the teeth surfaces. RMNPI scores are used to assess change in plaque scores at baseline and at the end of 2 weeks .This will be followed by a 1 week wash out period. Then there is a cross over in the intervention. RMNPI scores are measured again from Baseline and 2 weeks. Maximum number of surfaces examined are 504 per person. A Minimum value of 0 and maximum value of 1 can be calculated in each patient. Higher mean score is a worse outcome. However,higher percent reduction in mean score when compared to baseline is better outcome.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 28 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• Dental students of Dental school of Melaka-Manipal Medical College

Exclusion Criteria:

• Participants who had systemic diseases

• Gingivitis or periodontitis

• Use of antibiotics in the past 3 months,

• Pregnancy,

• Smoking

• Orthodontic appliances.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Faculty of Dentistry, Melaka-Manipal Medical College	Melaka Tengah	Melaka	Malaysia	57150

Sponsors and Collaborators

• Melaka Manipal Medical College
• Colgate Palmolive

Investigators

• Study Director: Abdul Rashid Ismail, BDS, Melaka Manipal Medical College

Study Documents (Full-Text)

• Study Protocol - Sep 4, 2019
• Informed Consent Form - Sep 4, 2019
• Statistical Analysis Plan - Jan 8, 2020

More Information

Additional Information:

• This systematic review suggests that a routine instruction to use floss is not supported by scientific evidence.

Publications

• Jayakumar A, Padmini H, Haritha A, Reddy KP. Role of dentifrice in plaque removal: a clinical trial. Indian J Dent Res. 2010 Apr-Jun;21(2):213-7. doi: 10.4103/0970-9290.66629.
• Mazhari F, Boskabady M, Moeintaghavi A, Habibi A. The effect of toothbrushing and flossing sequence on interdental plaque reduction and fluoride retention: A randomized controlled clinical trial. J Periodontol. 2018 Jul;89(7):824-832. doi: 10.1002/JPER.17-0149. Epub 2018 Jul 20.
• Torkzaban P, Arabi SR, Sabounchi SS, Roshanaei G. The Efficacy of Brushing and Flossing Sequence on Control of Plaque and Gingival Inflammation. Oral Health Prev Dent. 2015;13(3):267-73. doi: 10.3290/j.ohpd.a32678.
• Valkenburg C, Slot DE, Bakker EW, Van der Weijden FA. Does dentifrice use help to remove plaque? A systematic review. J Clin Periodontol. 2016 Dec;43(12):1050-1058. doi: 10.1111/jcpe.12615. Epub 2016 Oct 3. Review.
• Zanatta FB, Antoniazzi RP, Pinto TM, Rösing CK. Supragingival plaque removal with and without dentifrice: a randomized controlled clinical trial. Braz Dent J. 2012;23(3):235-40.

• Responsible Party: Rajesh Hosadurga, Professor, Melaka Manipal Medical College
• ClinicalTrials.gov Identifier: NCT03989427
• Other Study ID Numbers: MMMC/FOD/AR/B6
• First Posted: Jun 18, 2019
• Last Update Posted: Jun 2, 2020
• Last Verified: May 1, 2020

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Rajesh Hosadurga, Professor, Melaka Manipal Medical College: Gingiva; Gingivitis; Flossing; Brushing; Plaque control; Gingival bleeding; Bleeding point index; Rustogi Modified Navy Plaque Index; Dental Plaque; Tooth brushing
• Additional relevant MeSH terms: Gingivitis; Gingival Hemorrhage; Inflammation; Hemorrhage; Listerine; Sodium Fluoride

Study Results

Participant Flow

Recruitment Details	221 students were screened for eligibility between January 25, 2019 to May 10, 2019 in the Out-Patient Department (OPD) of Dept.of Periodontics, Poly clinic A, Klinik Pergigian, Melaka, Malaysia.
Pre-assignment Detail	30 of 221 participants were randomized. Of those not randomized, 120 did not meet inclusion criteria and 71 declined to participate.

Arm/Group Title	Brushing Flossing (BF)	Flossing Brushing (FB)
Arm/Group Description	Participants used Brushing first and Flossing (BF) sequence in the study. After 1 week wash out period they used Flossing first and brushing (FB) later sequence. Toothbrush used was Colgate® tooth brush- Soft bristled, waxed dental floss (Colgate® dental floss) and toothpaste (Colgate® tooth paste) were standardized. The method of brushing used was Modified Bass Method, the amount of dentifrice used is half-length of the toothbrush's head and Spool method of flossing was used.	Participants used Flossing first and brush (FB) later sequence in the study. After 1 week wash out period they used Brushing first and flossing (FB) later sequence. Toothbrush used was Colgate® tooth brush- Soft bristled, waxed dental floss (Colgate® dental floss) and toothpaste (Colgate® tooth paste) were standardized. The method of brushing used was Modified Bass Method, the amount of dentifrice used is half-length of the toothbrush's head and Spool method of flossing was used.
Period Title: First Intervention (2 Weeks)
STARTED	15	15
COMPLETED	15	15
NOT COMPLETED	0	0
Period Title: First Intervention (2 Weeks)
STARTED	15	15
COMPLETED	15	15
NOT COMPLETED	0	0
Period Title: First Intervention (2 Weeks)
STARTED	15	15
COMPLETED	15	15
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	Brushing Flossing (BF) First	Flossing Brushing (FB) First	Total
Arm/Group Description	Participants used Brushing first and Flossing later (BF) sequence for 2 weeks. After a washout period of 1 week they used flossing first and brushing later (FB) sequence Toothbrush used was Colgate® tooth brush- Soft bristled, waxed dental floss (Colgate® dental floss) and toothpaste (Colgate® tooth paste) were standardized. The method of brushing used was Modified Bass Method, the amount of dentifrice used is half-length of the toothbrush's head. The method of flossing used was Spool method of flossing.	Participants used Flossing first and Brushing later (FB) sequence for a period of 2 weeks. After a washout period of 1 week they used Brushing first and flossing later (BF) sequence Toothbrush used was Colgate® tooth brush- Soft bristled, waxed dental floss (Colgate® dental floss) and toothpaste (Colgate® tooth paste) were standardized. The method of brushing used was Modified Bass Method, the amount of dentifrice used is half-length of the toothbrush's head and the method of flossing used was Spool method of flossing.	Total of all reporting groups
Overall Participants	15	15	30
Age (Years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Years]	22.87 (0.52)	23.00 (0.38)	22.93 (0.45)
Sex: Female, Male (Count of Participants)
Female	14 93.3%	12 80%	26 86.7%
Male	1 6.7%	3 20%	4 13.3%
Race/Ethnicity, Customized (participants) [Number]
Malaysian Malay	6 40%	6 40%	12 40%
Malaysian Chinese	3 20%	4 26.7%	7 23.3%
Malaysian Indians	4 26.7%	3 20%	7 23.3%
others	2 13.3%	2 13.3%	4 13.3%
Region of Enrollment (participants) [Number]
Malaysia	15 100%	15 100%	30 100%
BPI scores (units on a scale) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [units on a scale]	1.8840 (1.765)	2.5253 (2.388)	2.2047 (2.089)
RMNPI index scores (units on a scale) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [units on a scale]	0.0866 (0.687)	0.025 (0.020)	0.080 (0.066)

Outcome Measures

1. Primary Outcome

Title	Change From Baseline in Mean BPI Index Scores at 2 Weeks
Description	Bleeding on probing (BOP) is an objective indicator of inflammation. BPI (Bleeding Point Index) is a validated index used to measure BOP. BOP is determined at the buccal, lingual and proximal surfaces of all teeth using BPI scores. BPI scores are measured at baseline and 2 weeks, followed by a wash out period of one week. BPI score is measured again at baseline and 2 weeks after cross over in intervention. Change in BPI scores will give the estimation of effect of the intervention. BPI score- minimum value is 0% and Maximum is 100% of bleeding surfaces in each individual patient with teeth. A positive error means that the predicted value is larger than the true value, and a negative error means that the predicted value is less than the true value. The mean error should be close to zero. Sometimes it will be negative or positive depending on the population.. Higher mean score is poor outcome. However, higher reduction in mean score compared to baseline is better outcome.
Time Frame	Baseline and 2 weeks

Outcome Measure Data

Analysis Population Description

All participants who received at least one intervention each and completed all study visits were included in the effectiveness analysis.

Arm/Group Title	Brushing First and Flossing Later (BF)	Flossing First and Brushing Later (FB)
Arm/Group Description	Participants who performed Brushing first and flossing later (BF) in either the first or last 2 weeks of the study	Participants who performed Flossing first and brushing later (FB) in either the first or last 2 weeks of the study.
Measure Participants	30	30
Mean (Standard Error) [score on a scale]	0.396 (0.410)	-1.028 (0.392)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Brushing First and Flossing Later (BF), Flossing First and Brushing Later (FB)
	Comments	Null hypothesis is that the sequence of brushing first and flossing later has no effect on gingival inflammation. No previous studies with Mean and SD were available. Hence, a pilot study was done. 30 participants were randomly assigned to Brush first and floss later (BF) group ; and Floss first brush later(FB) group. After 1 week there was cross-over. 80% power is required to detect mean difference in BPI scores.
	Type of Statistical Test	Equivalence
	Comments	The two treatment sequence could be called equivalent if the observed difference and its 95% CI are completely inside the interval of clinical equivalence. A significant result (p < 0.05) means that the two treatments are equivalent, according the definition of equivalence as defined clinically.
Statistical Test of Hypothesis	p-Value	0.022
	Comments	The threshold for statistical significance was p <0.05
	Method	ANOVA
	Comments	Three-way mixed ANOVA was done to determine the effect of Intervention on BPI scores .
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	1.424
	Confidence Interval	(2-Sided) 95%; 0.221 to 2.628
	Parameter Dispersion	Type: Value:
	Estimation Comments

2. Secondary Outcome

Title	Change From Baseline in Mean RMNPI Index Score at 2 Weeks
Description	Rustogi Modified Navy Plaque Index(RMNPI) is a self validated tool to assess dental plaque accumulation on the teeth surfaces. RMNPI scores are used to assess change in plaque scores at baseline and at the end of 2 weeks .This will be followed by a 1 week wash out period. Then there is a cross over in the intervention. RMNPI scores are measured again from Baseline and 2 weeks. Maximum number of surfaces examined are 504 per person. A Minimum value of 0 and maximum value of 1 can be calculated in each patient. Higher mean score is a worse outcome. However,higher percent reduction in mean score when compared to baseline is better outcome.
Time Frame	Baseline and 2 weeks

Outcome Measure Data

Analysis Population Description

All participants who received at least one intervention each and completed all study visits were included in the effectiveness analysis.

Arm/Group Title	Brushing First and Flossing Later (BF)	Flossing First and Brushing Later (FB)
Arm/Group Description	Participants who performed Brushing First and Flossing Later(BF) in either the first or last 2 weeks of the study.	Participants who performed Flossing First and Brushing later (FB) in either the first or last 2 weeks of the study.
Measure Participants	30	30
Mean (Standard Error) [score on a scale]	0.042 (1.043)	0.101 (1.427)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Brushing First and Flossing Later (BF), Flossing First and Brushing Later (FB)
	Comments	Null hypothesis: The sequence of brushing and flossing has no effect on plaque scores There were no previous studies with Mean and SD to calculate sample. So a pilot study was conducted. 30 participants were randomly assigned in 1:1 fashion to Brush-floss (GroupA) and Floss brush group (group B). Then after 1 week there was cross-over among the groups.2 groups would have at least 80% power to detect the mean difference in BPI scores.
	Type of Statistical Test	Equivalence
	Comments	The two treatment sequence could be called equivalent if the observed difference and its 95% CI are completely inside the interval of clinical equivalence. A significant result (p < 0.05) means that the two treatments are equivalent, according the definition of equivalence as defined clinically.
Statistical Test of Hypothesis	p-Value	0.971
	Comments
	Method	ANOVA
	Comments	Three-way mixed ANOVA was done to determine the effect of Intervention on RMNPI index scores
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	-0.058
	Confidence Interval	(2-Sided) 95%; -3.335 to 3.219
	Parameter Dispersion	Type: Value:
	Estimation Comments

Adverse Events

Time Frame	Baseline, 24 hours, 2 weeks, 5 weeks
Adverse Event Reporting Description	We followed the description provided by clinical trials. gov. Adverse event and serious adverse event was recorded in our data collection sheet for each participant. Checklist was prepared for each participant and attached to the data form. The data was recorded at baseline examination carried out in the morning clinical session, the participants were reviewed after 24 hours, 2 weeks and 5 weeks. They were asked to report immediately if any adverse events occurred in other periods of time.
Arm/Group Title	Brushing and Flossing
Arm/Group Description	No adverse events were reported
All Cause Mortality
	Brushing and Flossing
	Affected / at Risk (%)	# Events
Total	0/30 (0%)
Serious Adverse Events
	Brushing and Flossing
	Affected / at Risk (%)	# Events
Total	0/30 (0%)
Other (Not Including Serious) Adverse Events
	Brushing and Flossing
	Affected / at Risk (%)	# Events
Total	0/30 (0%)

Limitations/Caveats

There was no article with available to calculate sample size. Hence we conducted the pilot study among 30 participants. We recalculated the sample size from mean and SE of our study. It was estimated to be 40.

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.