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

NCT ID: NCT03989427

Last Updated: 2020-06-02

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-05-20

Study Completion Date

2020-01-20

Brief Summary

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

Detailed Description

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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.

Conditions

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Gingival Inflammation Plaque Gingival Bleeding Plaque Control

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

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.
Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors
The outcome assessor will record measurements at baseline and post intervention. The assessor will be blinded from the sequence of intervention allocation.

Study Groups

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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.

Group Type EXPERIMENTAL

Brushing first and Flossing later (BF)

Intervention Type 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.

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.

Group Type EXPERIMENTAL

Flossing first and Brushing later (FB)

Intervention Type 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.

Interventions

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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.

Intervention Type 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.

Intervention Type OTHER

Other Intervention Names

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Colgate® tooth brush and Colgate® Dental Floss Colgate® tooth brush and Colgate® Dental Floss

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

28 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Colgate Palmolive

INDUSTRY

Sponsor Role collaborator

Melaka Manipal Medical College

OTHER

Sponsor Role lead

Responsible Party

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Rajesh Hosadurga

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Abdul Rashid Ismail, BDS

Role: STUDY_DIRECTOR

Melaka Manipal Medical College

Locations

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Faculty of Dentistry, Melaka-Manipal Medical College

Melaka Tengah, Melaka, Malaysia

Site Status

Countries

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Malaysia

References

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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.

Reference Type BACKGROUND
PMID: 25197738 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 29741239 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 22814692 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 27513809 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 20657090 (View on PubMed)

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Informed Consent Form

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

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MMMC/FOD/AR/B6

Identifier Type: -

Identifier Source: org_study_id

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