Manual Versus Oscillating-rotating Toothbrushes After Root Coverage Procedure

Not Applicable

Completed

• Conditions: Gingival Recession
• Interventions: Device: Manual Toothbrush; Device: Oscillating-rotating toothbrush

• Registration Number: NCT02534220
• Lead Sponsor: University of Milan

Brief Summary

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

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.

Study Timeline

• Study Start: 2014-02
• Primary Completion: 2014-11
• Study Completion: 2014-11
• Status Verified: 2015-08
• Study First Submitted: 2015-08-21
• Study First Submitted QC: 2015-08-26
• Last Update Submitted: 2015-08-26
• Study First Posted: 2015-08-27
• Last Update Posted: 2015-08-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Manual Toothbrush	Manual Toothbrush	Patients were instructed in the Roll Brushing Technique, twice daily for 2 min.
Oscillating-rotating toothbrush	Oscillating-rotating toothbrush	Patients received manufacturer's instructions for use, including brushing twice daily for 2 min.

Primary Outcome Measures

Name	Time	Method
Change in Complete Root Coverage Rate	Change in Complete Root Coverage Rate at 6 months	Abscence of exposed root surface measured ad percentage

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Clinica Odontoiatrica IRCCS Ospedale Maggiore Policlinico; 🇮🇹 Milan, MI, Italy