Clinical trial NCT02534220: Manual Versus Oscillating-rotating Toothbrushes After Root Coverage Procedure
Official title: Gingival Margin Stability After Mucogingival Plastic Surgery. The Effect of Manual Versus Powered Toothbrushing: a Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Gingival Recession
Keywords: Toothbrushing
Oral hygiene
Dental hygiene
Lead sponsor: University of Milan
Sponsor class: OTHER
First posted: 2015-08-27
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Change in Complete Root Coverage Rate
timeFrame: Change in Complete Root Coverage Rate at 1 month
measure: Change in Complete Root Coverage Rate
timeFrame: Change in Complete Root Coverage Rate at 3 months
measure: Change in Complete Root Coverage Rate
timeFrame: Change in Complete Root Coverage Rate at 6 months
Secondary outcomes:
measure: Change in Recession Depth
timeFrame: Baseline, 1 month, 3 months, 6 months
measure: Change in Clinical Attachment Level
timeFrame: Baseline, 1 month, 3 months, 6 months
measure: Change in Probing Pocket Depth
timeFrame: Baseline, 1 month, 3 months, 6 months
Other outcomes:
Locations:
city: Milan
country: Italy
facility: Clinica Odontoiatrica IRCCS Ospedale Maggiore Policlinico
state: MI
Study officials:
affiliation: Unit of Periodontology, Department of Biomedical, Surgical and Dental Sciences, University of Milan, Foundation IRCCS Ca' Granda Policlinic
name: Giulio Rasperini
role: STUDY_DIRECTOR
References: