Efficacy of Different Toothbrushes and Hygiene Regimen

University of Nove de Julho

Status and phase

Unknown

Phase 2

Phase 1

Conditions

Dental Plaque

Halitosis

Treatments

Other: Total 12 regimen

Other: Toothbrushing alone

Study type

Interventional

Funder types

Other

Identifiers

NCT04216069

Toothbrushes

Details and patient eligibility

About

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).

Enrollment

58 estimated patients

Sex

All

Ages

12 to 17 years old

Volunteers

Accepts Healthy Volunteers

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).