NCT04216069

Efficacy of Different Toothbrushes and Hygiene Regimen

Status unknown Phase 1, PHASE2 Last updated 21 September 2020

What this trial tests

Phase 1, PHASE2 trial testing Total 12 regimen in Dental Plaque in 58 participants. Status unknown.

Timeline

5 January 2021

Primary endpoint
30 June 2021

25 December 2021

Quick facts

Lead sponsor	University of Nove de Julho
Phase	Phase 1, PHASE2
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	prevention
Enrollment	58
Start date	5 January 2021
Primary completion	30 June 2021
Estimated completion	25 December 2021
Sites	1 location across Brazil

Drugs / interventions tested

• Total 12 regimen
• Toothbrushing alone

Conditions studied

• Dental Plaque — all drugs for Dental Plaque →
• Halitosis — all drugs for Halitosis →

Sponsor

University of Nove de Julho

Who can join

Adults 12 to 17, any sex, with Dental Plaque or Halitosis. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

To evaluate: 1) Evaluate the efficacy of a regimen commercially available versus brush alone on established plaque and gingivitis on adolescents. The Group 1 will use the following procedure: Colgate Ultrasoft toothbrush, Colgate Total 12 toothpaste and Plax Mouthwash, and the other Group will use Colgate Ultrasoft toothbrush and Colgate Cavity Protection toothpaste; 2) The level of halitosis. Two calibrated and blinded examiners (Cohen Kappa 85%) will evaluate the gingival condition using the visible plaque indices, a simplified oral hygiene index - IHOS and gingival bleeding index, with the aid of a WHO probe. For the evaluation of halitosis levels, all individuals will respond to a questionnaire regarding personal data, general and oral health, which includes hygiene habits and received previous guidelines for the procedures to be performed in the second moment. At the next consultation, subjects will be assessed clinically for halitosis using the portable BreathAlert™ sulfide monitor (Tanita Corporation, Japan), in addition to the evaluation of the tongue flap index (ISL), pH and salivary flow. The evaluations will be in the following periods: baseline, 1, 3 and 6 months of brushing. Data will be submitted to descriptive statistical analysis to demonstrate the distributions frequency of biofilm indices and gingival bleeding. The differences in the criteria evaluated will be submitted to Fisher's exact test (α = 0.05) and their performance at different times will be evaluated by the Mann-Whitney test (α = 0.05).

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Evaluation of the efficacy of a commercially available regimen vs brushing alone on established plaque and gingivitis on adolescents: Study protocol for a randomized, controlled, blind clinical trial.
   Moriyama CM, Santos EM, Gonçalves MLL, Tubel CA, et al · · 2020 · cited 1× · PMID 33157981 · DOI 10.1097/md.0000000000023092