Efficacy of Different Toothbrushes and Hygiene Regimen

Evaluation of the Efficacy of a Commercially Available Regimen Versus Brushing Alone on Established Plaque and Gingivitis on Adolescents: Study Protocol for a Randomized, Controlled, Blind Clinical Trial

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).

Study Overview

• Status: Unknown
• Conditions: Dental Plaque; Halitosis
• Intervention / Treatment: Other: Total 12 regimen; Other: Toothbrushing alone

• Study Type: Interventional
• Enrollment (Anticipated): 58
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• Brazil
  • SP
    • Santos, SP, Brazil, 11045-401
      • Universidade Metropolitana De Santos
      • Contact: Caroline M Moriyama, PhD; Phone Number: +55 13 32283400; Email: caroline.cmm@hotmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 12 years to 17 years (Child)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Good general health;
• Age 12 to 17;
• Absence of motor, comprehension and cognitive difficulties that impede adequate oral hygiene.

Exclusion Criteria:

• Active dental caries with cavity exposing dentin (visible cavity) on teeth for which the simplified oral hygiene index will be used. If these teeth are not present, adjacent teeth may be considered;
• Teeth with formation defects and dental crowding;
• Periodontal disease (tooth mobility > 2 mm, pocket > 5 mm, gingivitis);
• Parafunctional habits (bruxism, nail biting), active clamps for removable partial dentures, use of orthodontic appliance;
• Volunteer or legal guardian who does not agree with the terms of the study or has difficulty appearing for the follow up appointments;
• Pregnant volunteers;
• Use of medications that alter gingival health, such as antibiotics, in the previous three months;
• Use of mouthwash or toothpaste containing products for the control of biofilm;
• Smokers;
• Systemic disease (diabetes).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Total 12 regimen group; This group will use the following procedure: Colgate Ultrasoft toothbrush, Colgate Total 12 toothpaste and Plax Mouthwash.	Other: Total 12 regimen; The volunteers will be invited with their caregivers to a lecture administered with the aim of clarifying the importance of oral hygiene and motivating brushing among the volunteers. Written clarifications will also be given in the form of an illustrative pamphlet. The volunteers will be trained in the technique through supervised brushing in front of a mirror. Subjects from the Group 1 will use a regimen with Colgate Total 12 toothpaste + Plax mouthwash + Colgate Ultrasoft toothbrush. Subjects will be instructed to use only their assigned group during the study period. The treatment products will be re-supplied at regular intervals. Subjects will return with their assigned products to the study site before receiving new products. There will be no restrictions regarding diet habits during the course of the study. Upon completion of the study, subjects will be instructed to return all used and used products.
Experimental: Tooth brushing alone group; This group will use Colgate Ultrasoft toothbrush and Colgate Cavity Protection toothpaste.	Other: Toothbrushing alone; The volunteers will be invited with their caregivers to a lecture administered with the aim of clarifying the importance of oral hygiene and motivating brushing among the volunteers. Written clarifications will also be given in the form of an illustrative pamphlet. The volunteers will be trained in the technique through supervised brushing in front of a mirror. Group 2 will use Colgate Cavity Protection Toothpaste + Colgate Ultrasoft toothbrush. Subjects will be instructed to use only their assigned group during the study period. The treatment products will be re-supplied at regular intervals. Subjects will return with their assigned products to the study site before receiving new products. There will be no restrictions regarding diet habits during the course of the study. Upon completion of the study, subjects will be instructed to return all used and used products.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evaluation of change in biofilm index	The gingival health assessments will be performed through a visual examination for the determination of the visible plaque index, gingival bleeding and oral health at baseline as well as after the use of brush.	Baseline, after 1, 3 and 6 months of toothbrushing.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in halitosis index	Halitosis index using the portable BreathAlert™ sulfide monitor (Tanita Corporation, Japan).	Baseline, after 1, 3 and 6 months of toothbrushing.

Collaborators and Investigators

• Sponsor: University of Nove de Julho

Study record dates

Study Major Dates

• Study Start (Anticipated): January 5, 2021
• Primary Completion (Anticipated): June 30, 2021
• Study Completion (Anticipated): December 25, 2021

Study Registration Dates

• First Submitted: December 18, 2019
• First Submitted That Met QC Criteria: December 31, 2019
• First Posted (Actual): January 2, 2020

Study Record Updates

• Last Update Posted (Actual): September 21, 2020
• Last Update Submitted That Met QC Criteria: September 17, 2020
• Last Verified: September 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Signs and Symptoms, Digestive; Stomatognathic Diseases; Tooth Diseases; Dental Deposits; Dental Plaque; Halitosis
• Other Study ID Numbers: Toothbrushes

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No