Clinical trial NCT04216069: Efficacy of Different Toothbrushes and Hygiene Regimen
Official title: 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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: Dental Plaque
Halitosis
Lead sponsor: University of Nove de Julho
Sponsor class: OTHER
First posted: 2020-01-02
Enrollment: 58
Sex: ALL
Minimum age (years): 12
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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).


Eligibility criteria: 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).

Primary outcomes:
measure: Evaluation of change in biofilm index
timeFrame: Baseline, after 1, 3 and 6 months of toothbrushing.
Secondary outcomes:
measure: Change in halitosis index
timeFrame: Baseline, after 1, 3 and 6 months of toothbrushing.
Other outcomes:
Locations:
city: Santos
country: Brazil
facility: Universidade Metropolitana de Santos
state: SP
Study officials:
References: