Gingival Margin Stability After Mucogingival Plastic Surgery. The Effect of Manual Versus Powered Toothbrushing: a Randomized Clinical Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- University of Milan
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- Change in Complete Root Coverage Rate
Study Overview
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
- •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
Arms & Interventions
Manual Toothbrush
Patients were instructed in the Roll Brushing Technique, twice daily for 2 min.
Intervention: Manual Toothbrush (Device)
Oscillating-rotating toothbrush
Patients received manufacturer's instructions for use, including brushing twice daily for 2 min.
Intervention: Oscillating-rotating toothbrush (Device)
Outcomes
Primary Outcomes
Change in Complete Root Coverage Rate
Time Frame: Change in Complete Root Coverage Rate at 6 months
Abscence of exposed root surface measured ad percentage
Change in Complete Root Coverage Rate
Time Frame: Change in Complete Root Coverage Rate at 1 month
Abscence of exposed root surface measured ad percentage
Change in Complete Root Coverage Rate
Time Frame: Change in Complete Root Coverage Rate at 3 months
Abscence of exposed root surface measured ad percentage
Secondary Outcomes
- Change in Recession Depth(Baseline, 1 month, 3 months, 6 months)
- Change in Clinical Attachment Level(Baseline, 1 month, 3 months, 6 months)
- Change in Probing Pocket Depth(Baseline, 1 month, 3 months, 6 months)
Investigators
Giulio Rasperini
Prof.
University of Milan