Manual Versus Oscillating-rotating Toothbrushes After Root Coverage Procedure

Gingival Recession Clinical Trial

Official title:

Gingival Margin Stability After Mucogingival Plastic Surgery. The Effect of Manual Versus Powered Toothbrushing: a Randomized Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02534220
• Other study ID #: Oral-B
• Status: Completed
• Phase: N/A
• First received: August 21, 2015
• Last updated: August 26, 2015
• Start date: February 2014
• Est. completion date: November 2014

Study information

• Verified date: August 2015
• Source: University of Milan
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: November 2014
• Est. primary completion date: November 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Gingival Recession

Intervention

Device:
• Manual Toothbrush
Gum Delicate Post-Surgical Toothbrush, Oral-B, Procter & Gamble, Cincinnati, OH
• Oscillating-rotating toothbrush
Triumph 5000, Oral-B, Procter & Gamble, Cincinnati, OH

Locations

Country	Name	City	State
Italy	Clinica Odontoiatrica IRCCS Ospedale Maggiore Policlinico	Milan	MI

Sponsors (1)

Lead Sponsor	Collaborator
University of Milan

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Complete Root Coverage Rate	Abscence of exposed root surface measured ad percentage	Change in Complete Root Coverage Rate at 1 month	No
Primary	Change in Complete Root Coverage Rate	Abscence of exposed root surface measured ad percentage	Change in Complete Root Coverage Rate at 3 months	No
Primary	Change in Complete Root Coverage Rate	Abscence of exposed root surface measured ad percentage	Change in Complete Root Coverage Rate at 6 months	No
Secondary	Change in Recession Depth	Distance from the gingival margin to the cementum-enamel junction, measured in millimeters	Baseline, 1 month, 3 months, 6 months	No
Secondary	Change in Clinical Attachment Level	Distance from the cementum-enamel junction to the bottom of the periodontal Pocket, measured in millimeters	Baseline, 1 month, 3 months, 6 months	No
Secondary	Change in Probing Pocket Depth	Distance from the gingival margin to the bottom of the periodontal pocket, measured in millimeters	Baseline, 1 month, 3 months, 6 months	No