NCT02534220

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2014

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2014

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2014

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

August 21, 2015

Completed
6 days until next milestone

First Posted

Study publicly available on registry

August 27, 2015

Completed
Last Updated

August 27, 2015

Status Verified

August 1, 2015

Enrollment Period

9 months

First QC Date

August 21, 2015

Last Update Submit

August 26, 2015

Conditions

Gingival Recession

Keywords

ToothbrushingOral hygieneDental hygiene

Outcome Measures

Primary Outcomes (3)

  • Change in Complete Root Coverage Rate

    Abscence of exposed root surface measured ad percentage

    Change in Complete Root Coverage Rate at 1 month

  • Change in Complete Root Coverage Rate

    Abscence of exposed root surface measured ad percentage

    Change in Complete Root Coverage Rate at 3 months

  • Change in Complete Root Coverage Rate

    Abscence of exposed root surface measured ad percentage

    Change in Complete Root Coverage Rate at 6 months

Secondary Outcomes (3)

  • 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

Study Arms (2)

Manual Toothbrush

ACTIVE COMPARATOR

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

Device: Manual Toothbrush

Oscillating-rotating toothbrush

EXPERIMENTAL

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

Device: Oscillating-rotating toothbrush

Interventions

Manual ToothbrushDEVICE

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

Manual Toothbrush
Oscillating-rotating toothbrushDEVICE

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

Oscillating-rotating toothbrush

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Full-Mouth Plaque Score (FMPS) ≤25%
  • Full-Mouth Bleeding Score (FMBS) ≤25%
  • Miller Class I and II buccal recession ≥2 mm

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Clinica Odontoiatrica IRCCS Ospedale Maggiore Policlinico

Milan, MI, 20122, Italy

Location

MeSH Terms

Conditions

Gingival Recession

Condition Hierarchy (Ancestors)

Gingival DiseasesPeriodontal DiseasesMouth DiseasesStomatognathic DiseasesPeriodontal Atrophy

Study Officials

  • Giulio Rasperini

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

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof.

Study Record Dates

First Submitted

August 21, 2015

First Posted

August 27, 2015

Study Start

February 1, 2014

Primary Completion

November 1, 2014

Study Completion

November 1, 2014

Last Updated

August 27, 2015

Record last verified: 2015-08

Locations

IT(1)