Manual Versus Oscillating-rotating Toothbrushes After Root Coverage Procedure

NCT ID: NCT02534220

Last Updated: 2015-08-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-02-28
• Study Completion Date: 2014-11-30

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.

Conditions

Gingival Recession

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Manual Toothbrush

Patients were instructed in the Roll Brushing Technique, twice daily for 2 min.

Group Type: ACTIVE_COMPARATOR

Manual Toothbrush

Intervention Type: DEVICE

Gum Delicate Post-Surgical Toothbrush, Oral-B, Procter \& Gamble, Cincinnati, OH

Oscillating-rotating toothbrush

Patients received manufacturer's instructions for use, including brushing twice daily for 2 min.

Group Type: EXPERIMENTAL

Oscillating-rotating toothbrush

Intervention Type: DEVICE

Triumph 5000, Oral-B, Procter \& Gamble, Cincinnati, OH

Interventions

Manual Toothbrush

Gum Delicate Post-Surgical Toothbrush, Oral-B, Procter \& Gamble, Cincinnati, OH

Intervention Type: DEVICE

Oscillating-rotating toothbrush

Triumph 5000, Oral-B, Procter \& Gamble, Cincinnati, OH

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Milan

OTHER

Sponsor Role: lead

Responsible Party

Giulio Rasperini

Prof.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Giulio Rasperini

Role: STUDY_DIRECTOR

Unit of Periodontology, Department of Biomedical, Surgical and Dental Sciences, University of Milan, Foundation IRCCS Ca' Granda Policlinic

Locations

Clinica Odontoiatrica IRCCS Ospedale Maggiore Policlinico

Milan, MI, Italy

Countries

Italy

Other Identifiers

Oral-B

Identifier Type: -

Identifier Source: org_study_id