Clinical trial NCT03989427: The Effectiveness of Brushing and Flossing Sequence on Control of Plaque and Gingival Inflammation
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
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
Lead sponsor: Melaka Manipal Medical College
Sponsor class: OTHER
Collaborators: name: Colgate Palmolive
First posted: 2019-06-18
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 28
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
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.
Primary purpose: PREVENTION

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

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change From Baseline in Mean BPI Index Scores at 2 Weeks
timeFrame: Baseline and 2 weeks
Secondary outcomes:
measure: Change From Baseline in Mean RMNPI Index Score at 2 Weeks
timeFrame: Baseline and 2 weeks
Other outcomes:
Locations:
city: Melaka Tengah
country: Malaysia
facility: Faculty of Dentistry, Melaka-Manipal Medical College
state: Melaka
Study officials:
affiliation: Melaka Manipal Medical College
name: Abdul Rashid Ismail, BDS
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.