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

The Effectiveness of Brushing and Flossing Sequence on Control of Plaque and Gingival Inflammation-A Randomized Controlled Clinical Trial in Klinik Pergigian, MMMC, Melaka

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

Study Overview

• Status: Completed
• Conditions: Plaque; Gingival Inflammation; Gingival Bleeding; Plaque Control
• Intervention / Treatment: Other: Brushing first and Flossing later (BF); Other: Flossing first and Brushing later (FB)

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 Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Malaysia
  • Melaka
    • Melaka Tengah, Melaka, Malaysia, 57150
      • Faculty of Dentistry, Melaka-Manipal Medical College

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 28 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change From Baseline in Mean BPI Index Scores at 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.	Baseline and 2 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change From Baseline in Mean RMNPI Index Score at 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.	Baseline and 2 weeks

Collaborators and Investigators

• Sponsor: Melaka Manipal Medical College
• Collaborators: Colgate Palmolive
• Investigators: Study Director: Abdul Rashid Ismail, BDS, Melaka Manipal Medical College

Publications and helpful links

General Publications

• 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.
• 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.
• Zanatta FB, Antoniazzi RP, Pinto TM, Rosing CK. Supragingival plaque removal with and without dentifrice: a randomized controlled clinical trial. Braz Dent J. 2012;23(3):235-40. doi: 10.1590/s0103-64402012000300009.
• 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.
• 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.

Helpful Links

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

Study record dates

Study Major Dates

• Study Start (Actual): May 20, 2019
• Primary Completion (Actual): December 15, 2019
• Study Completion (Actual): January 20, 2020

Study Registration Dates

• First Submitted: June 14, 2019
• First Submitted That Met QC Criteria: June 14, 2019
• First Posted (Actual): June 18, 2019

Study Record Updates

• Last Update Posted (Actual): June 2, 2020
• Last Update Submitted That Met QC Criteria: May 30, 2020
• Last Verified: May 1, 2020

More Information

Terms related to this study

• Keywords: Gingiva; Dental Plaque; Brushing; Flossing; Gingivitis; Plaque control; Gingival bleeding; Bleeding point index; Rustogi Modified Navy Plaque Index; Tooth brushing
• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Stomatognathic Diseases; Periodontal Diseases; Mouth Diseases; Gingival Diseases; Oral Hemorrhage; Inflammation; Hemorrhage; Gingivitis; Gingival Hemorrhage; Physiological Effects of Drugs; Anti-Infective Agents, Local; Anti-Infective Agents; Protective Agents; Cariostatic Agents; Listerine; Sodium Fluoride
• Other Study ID Numbers: MMMC/FOD/AR/B6

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: If Requested by authors for systematic review, study results will be shared for secondary research.
• IPD Sharing Time Frame: January 2020- January 2023

IPD Sharing Access Criteria

IPD access will be given only to bona fide research groups as evidenced via their resume and the involvement of a qualified statistician.

Consent will be taken from the participants about data sharing prior to the commencement of the study. Confidentiality will be strictly maintained.

Data custodians are scientific committee, Faculty of Dentistry, MMMC, Melaka. Data access will be reviewed and approved by DRC based on Merits of requests.

• IPD Sharing Supporting Information Type: Study Protocol; Statistical Analysis Plan (SAP); Informed Consent Form (ICF); Clinical Study Report (CSR); Analytic Code

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No