Back to results

Manual Versus Oscillating-rotating Toothbrushes After Root Coverage Procedure

Primary Purpose

Gingival Recession

Status

Completed

Phase

Not Applicable

Locations

Italy

Study Type

Interventional

Intervention

Manual Toothbrush

Oscillating-rotating toothbrush

About this trial

This is an interventional treatment trial for Gingival Recession focused on measuring Toothbrushing, Oral hygiene, Dental hygiene

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Clinica Odontoiatrica IRCCS Ospedale Maggiore Policlinico

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Manual Toothbrush

Oscillating-rotating toothbrush

Arm Description

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

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

Outcomes

Primary Outcome Measures

Change in Complete Root Coverage Rate

Abscence of exposed root surface measured ad percentage

Change in Complete Root Coverage Rate

Abscence of exposed root surface measured ad percentage

Change in Complete Root Coverage Rate

Abscence of exposed root surface measured ad percentage

Secondary Outcome Measures

Change in Recession Depth

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

Change in Clinical Attachment Level

Distance from the cementum-enamel junction to the bottom of the periodontal Pocket, measured in millimeters

Change in Probing Pocket Depth

Distance from the gingival margin to the bottom of the periodontal pocket, measured in millimeters

Full Information

NCT ID

NCT02534220

First Posted

August 21, 2015

Last Updated

August 26, 2015

Sponsor

University of Milan

1. Study Identification

Unique Protocol Identification Number

NCT02534220

Brief Title

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

2. Study Status

Record Verification Date

August 2015

Overall Recruitment Status

Completed

Study Start Date

February 2014 (undefined)

Primary Completion Date

November 2014 (Actual)

Study Completion Date

November 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of Milan

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Gingival Recession

Keywords

Toothbrushing, Oral hygiene, Dental hygiene

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

InvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

60 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Manual Toothbrush

Arm Type

Active Comparator

Arm Description

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

Arm Title

Oscillating-rotating toothbrush

Arm Type

Experimental

Arm Description

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

Intervention Type

Device

Intervention Name(s)

Manual Toothbrush

Intervention Description

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

Intervention Type

Device

Intervention Name(s)

Oscillating-rotating toothbrush

Intervention Description

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

Primary Outcome Measure Information:

Title

Change in Complete Root Coverage Rate

Description

Abscence of exposed root surface measured ad percentage

Time Frame

Change in Complete Root Coverage Rate at 1 month

Title

Change in Complete Root Coverage Rate

Description

Abscence of exposed root surface measured ad percentage

Time Frame

Change in Complete Root Coverage Rate at 3 months

Title

Change in Complete Root Coverage Rate

Description

Abscence of exposed root surface measured ad percentage

Time Frame

Change in Complete Root Coverage Rate at 6 months

Secondary Outcome Measure Information:

Title

Change in Recession Depth

Description

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

Time Frame

Baseline, 1 month, 3 months, 6 months

Title

Change in Clinical Attachment Level

Description

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

Title

Change in Probing Pocket Depth

Description

Distance from the gingival margin to the bottom of the periodontal pocket, measured in millimeters

Time Frame

Baseline, 1 month, 3 months, 6 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Giulio Rasperini

Organizational Affiliation

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

Official's Role

Study Director

Facility Information:

Facility Name

Clinica Odontoiatrica IRCCS Ospedale Maggiore Policlinico

City

Milan

State/Province

ZIP/Postal Code

20122

Country

Italy

12. IPD Sharing Statement

Learn more about this trial

Manual Versus Oscillating-rotating Toothbrushes After Root Coverage Procedure

We'll reach out to this number within 24 hrs