NCT03989427: RCT

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

Completed NA Results posted Last updated 2 June 2020

What this trial tests

NA trial testing Brushing first and Flossing later (BF) in Gingival Inflammation in 30 participants. Completed in 20 January 2020.

Timeline

20 May 2019

Primary endpoint
15 December 2019

20 January 2020

Quick facts

Lead sponsor	Melaka Manipal Medical College
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	crossover
Masking	single
Primary purpose	prevention
Enrollment	30
Start date	20 May 2019
Primary completion	15 December 2019
Estimated completion	20 January 2020
Sites	1 location across Malaysia

Drugs / interventions tested

• Brushing first and Flossing later (BF)
• Flossing first and Brushing later (FB)

Conditions studied

• Gingival Inflammation — all drugs for Gingival Inflammation →
• Plaque — all drugs for Plaque →
• Gingival Bleeding — all drugs for Gingival Bleeding →
• Plaque Control — all drugs for Plaque Control →

Sponsor

Melaka Manipal Medical College

Who can join

Adults 18 to 28, any sex, with Gingival Inflammation or Plaque. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Change From Baseline in Mean BPI Index Scores at 2 Weeks Primary · 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

Group	Value	95% CI
Brushing First and Flossing Later (BF)	0.396	± 0.410
Flossing First and Brushing Later (FB)	-1.028	± 0.392

Change From Baseline in Mean RMNPI Index Score at 2 Weeks Secondary · 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

Group	Value	95% CI
Brushing First and Flossing Later (BF)	0.042	± 1.043
Flossing First and Brushing Later (FB)	0.101	± 1.427

Sponsor's own description

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

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.