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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Total 12 regimen group | Experimental | This group will use the following procedure: Colgate Ultrasoft toothbrush, Colgate Total 12 toothpaste and Plax Mouthwash. |
|
| Tooth brushing alone group | Experimental | This group will use Colgate Ultrasoft toothbrush and Colgate Cavity Protection toothpaste. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Total 12 regimen | Other | 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. |
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in halitosis index | Halitosis index using the portable BreathAlertâ„¢ sulfide monitor (Tanita Corporation, Japan). | Baseline, after 1, 3 and 6 months of toothbrushing. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Universidade Metropolitana de Santos | Santos | São Paulo | 11045-401 | Brazil |
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| ID | Term |
|---|---|
| D003773 | Dental Plaque |
| D006209 | Halitosis |
| ID | Term |
|---|---|
| D003741 | Dental Deposits |
| D014076 | Tooth Diseases |
| D009057 | Stomatognathic Diseases |
| D012817 | Signs and Symptoms, Digestive |
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| ID | Term |
|---|---|
| D014099 | Toothbrushing |
| ID | Term |
|---|---|
| D009910 | Oral Hygiene |
| D011313 | Preventive Dentistry |
| D003813 | Dentistry |
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The outcome assessor will not know to which group the participant belongs.
|
| Toothbrushing alone | Other | 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. |
|
| D012816 |
| Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |