Manual Versus Oscillating-rotating Toothbrushes After Root Coverage Procedure

University of Milan60 enrolled

Overview

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

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Gingival Recession

Interventions

Manual ToothbrushDEVICE

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

Oscillating-rotating toothbrushDEVICE

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Clinica Odontoiatrica IRCCS Ospedale Maggiore Policlinico

Milan, MI, Italy

Outcomes

Primary Outcomes

Change in Complete Root Coverage Rate

Abscence of exposed root surface measured ad percentage

Time frame: Change in Complete Root Coverage Rate at 1 month

Change in Complete Root Coverage Rate

Abscence of exposed root surface measured ad percentage

Time frame: Change in Complete Root Coverage Rate at 3 months

Change in Complete Root Coverage Rate

Abscence of exposed root surface measured ad percentage

Time frame: Change in Complete Root Coverage Rate at 6 months

Secondary Outcomes

Change in Recession Depth

Distance from the gingival margin to the cementum-enamel junction, measured in millimeters

Time frame: 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

Time frame: 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

Time frame: Baseline, 1 month, 3 months, 6 months

Data from ClinicalTrials.gov

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