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

NCT03989427 | Completed Results DMC

• 1 other identifier: MMMC/FOD/AR/B6
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Gingival Inflammation; Plaque; Gingival Bleeding; Plaque Control

Keywords

Gingiva; Gingivitis; Flossing; Brushing; Plaque control; Gingival bleeding; Bleeding point index; Rustogi Modified Navy Plaque Index; Dental Plaque; Tooth brushing

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Change From Baseline in Mean RMNPI Index Score at 2 Weeks

  Baseline and 2 weeks

Study Arms (2)

Brushing First and Flossing Later (BF)

EXPERIMENTAL

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)

Flossing First and Brushing Later (FB)

EXPERIMENTAL

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)

Interventions

Brushing first and Flossing later (BF) OTHER

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.

Also known as: Colgate® tooth brush and Colgate® Dental Floss

Brushing First and Flossing Later (BF)

Flossing first and Brushing later (FB) OTHER

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.

Also known as: Colgate® tooth brush and Colgate® Dental Floss

Flossing First and Brushing Later (FB)

Eligibility Criteria

• Age: 18 Years - 28 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• Participants who had systemic diseases
• Gingivitis or periodontitis
• Use of antibiotics in the past 3 months,
• Pregnancy,
• Smoking
• Orthodontic appliances.

Sponsors & Collaborators

• Melaka Manipal Medical College: lead
• Colgate Palmolive: collaborator

Study Sites (1)

Faculty of Dentistry, Melaka-Manipal Medical College

Melaka Tengah, Melaka, 57150, Malaysia

Location

Related Publications (5)

• 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.

  PMID: 25197738 BACKGROUND

• 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.

  PMID: 29741239 BACKGROUND

• 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.

  PMID: 22814692 BACKGROUND

• 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.

  PMID: 27513809 BACKGROUND

• 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.

  PMID: 20657090 BACKGROUND

MeSH Terms

Conditions

Gingivitis; Plaque, Amyloid; Gingival Hemorrhage; Dental Plaque

Condition Hierarchy (Ancestors)

Infections; Gingival Diseases; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Oral Hemorrhage; Hemorrhage; Pathologic Processes; Dental Deposits; Tooth Diseases

Limitations and 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.

Results Point of Contact

• Title: Dr. Rajesh Hosadurga
• Organization: Melaka-Manipal Medical College

rajesh.hosadurga@manipal.edu.my

+6062896662

Study Officials

• Abdul Rashid Ismail, BDS

  Melaka Manipal Medical College

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The outcome assessor will record measurements at baseline and post intervention. The assessor will be blinded from the sequence of intervention allocation.
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: 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.

Study Record Dates

• First Submitted: June 14, 2019
• First Posted: June 18, 2019
• Study Start: May 20, 2019
• Primary Completion: December 15, 2019
• Study Completion: January 20, 2020
• Last Updated: June 2, 2020
• Results First Posted: June 2, 2020

Record last verified: 2020-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: January 2020- January 2023
• 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.

Locations

MY (1)