Manual Versus Oscillating-rotating Toothbrushes After Root Coverage Procedure

Study Overview
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Brief Summary
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The aim of this study is to evaluate the gingival margin stability with the use of oscillating-rotating toothbrushes compared to manual toothbrushes.

Detailed Description
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BACKGROUND Oscillating-rotating power toothbrushes have been proven clinically efficacious. To the investigators' knowledge, a clinical evaluation of the safety of these toothbrushes after surgical root coverage procedure have not been published. The aim of this study is to evaluate the gingival margin stability with the use of oscillating-rotating toothbrushes compared to manual toothbrushes. METHODS Sixty healthy patients with at least a single Miller Class I or II gingival recession underwent surgical root coverage procedure. Soft-bristle manual and powered toothbrushes were given to participants randomly assigned to control and test group, respectively. Full-mouth plaque score, Full-mouth Bleeding Score, Probing Pocket Depth and Recession Depth were recorded 1, 3 and 6 months after completion of surgical procedure. Longitudinal analyses were performed using linear random-intercept models to take into account within-subject correlations over time. Temporal trend differences across treatments by including treatment-time interaction terms were then tested using a global Wald test.

Official Title
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Gingival Margin Stability After Mucogingival Plastic Surgery. The Effect of Manual Versus Powered Toothbrushing: a Randomized Clinical Trial

Conditions
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Gingival Recession

Intervention / Treatment
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* Device: Manual Toothbrush
* Device: Oscillating-rotating toothbrush


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Full-Mouth Plaque Score (FMPS) ≤25% Full-Mouth Bleeding Score (FMBS) ≤25% Miller Class I and II buccal recession ≥2 mm Exclusion Criteria: Relevant systemic condition or disease Smokers Teeth with prosthetic crowns or restorations in the cervical area Presence of pulling frenum in the keratinized tissue Previous mucogingival or periodontal surgery in the experimental site

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Manual Toothbrush<br>Patients were instructed in the Roll Brushing Technique, twice daily for 2 min. | Device: Manual Toothbrush<br>* Gum Delicate Post-Surgical Toothbrush, Oral-B, Procter & Gamble, Cincinnati, OH<br>|
| Experimental: Oscillating-rotating toothbrush<br>Patients received manufacturer's instructions for use, including brushing twice daily for 2 min. | Device: Oscillating-rotating toothbrush<br>* Triumph 5000, Oral-B, Procter & Gamble, Cincinnati, OH<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Complete Root Coverage Rate | Abscence of exposed root surface measured ad percentage | Change in Complete Root Coverage Rate at 1 month | 
| Change in Complete Root Coverage Rate | Abscence of exposed root surface measured ad percentage | Change in Complete Root Coverage Rate at 3 months | 
| Change in Complete Root Coverage Rate | Abscence of exposed root surface measured ad percentage | Change in Complete Root Coverage Rate at 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Recession Depth | Distance from the gingival margin to the cementum-enamel junction, measured in millimeters | Baseline, 1 month, 3 months, 6 months | 
| Change in Clinical Attachment Level | Distance from the cementum-enamel junction to the bottom of the periodontal Pocket, measured in millimeters | Baseline, 1 month, 3 months, 6 months | 
| Change in Probing Pocket Depth | Distance from the gingival margin to the bottom of the periodontal pocket, measured in millimeters | Baseline, 1 month, 3 months, 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Toothbrushing, Oral hygiene, Dental hygiene