NCT01175720

Brief Summary

The aim of this study is to test a surgical technique for the treatment of gingival recessions. The hypothesis of the study is to promote greater root coverage and better healing.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
15

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2010

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

August 1, 2010

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

August 3, 2010

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 5, 2010

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2011

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2011

Completed
Last Updated

November 16, 2011

Status Verified

November 1, 2011

Enrollment Period

10 months

First QC Date

August 3, 2010

Last Update Submit

November 11, 2011

Conditions

Keywords

gingival recessionacellular dermal matrix graftroot coverage

Outcome Measures

Primary Outcomes (1)

  • Percentage of root coverage

    Clinical parameters will be assessed after 6 months of surgical procedures.

    6 months

Secondary Outcomes (1)

  • Keratinized Tissue

    6 months

Study Arms (1)

test and control

EXPERIMENTAL

The test and control technique will be tested in a split-mouth design.

Procedure: Periodontal surgery to gingival recessions

Interventions

Test and control technique to treat gingival recessions.

test and control

Eligibility Criteria

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

You may qualify if:

  • Recession defects are Miller's class I or II and do not vary more or equal than 3 mm
  • Main complaint aesthetic issues or dentine hypersensitivity
  • The patient must be a candidate for bilateral root coverage procedure
  • Patient shows sufficient plaque control (FMPS \< 20%)
  • The patient is able to comply with the study-related procedures such as exercising good oral hygiene and attending all follow-up procedures
  • The patient is able to fully understand the nature of the proposed surgery and is able to provide a signed informed consent

You may not qualify if:

  • Smokers
  • Systemic diseases
  • Pregnants or lactating
  • Periodontal disease
  • General contraindications for dental and/or surgical treatment are present
  • The patient has a history of malignancy, radiotherapy, or chemotherapy for malignancy within the past five years
  • The patient is taking medications or having treatments which have an effect on mucosal healing in general (e.g. steroids, large doses of anti-inflammatory drugs)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Dentistry of Ribeirão Preto USP

Ribeirão Preto, São Paulo, 14040-904, Brazil

Location

Related Publications (1)

  • Ayub LG, Ramos UD, Reino DM, Grisi MF, Taba M Jr, Souza SL, Palioto DB, Novaes AB Jr. A Randomized comparative clinical study of two surgical procedures to improve root coverage with the acellular dermal matrix graft. J Clin Periodontol. 2012 Sep;39(9):871-8. doi: 10.1111/j.1600-051X.2012.01915.x. Epub 2012 Jun 19.

MeSH Terms

Conditions

Gingival Recession

Condition Hierarchy (Ancestors)

Gingival DiseasesPeriodontal DiseasesMouth DiseasesStomatognathic DiseasesPeriodontal Atrophy

Study Officials

  • Arthur B. Novaes Júnior, PhD

    University of Sao Paulo

    PRINCIPAL INVESTIGATOR
  • Lauro G. Ayub, MSD student

    University of Sao Paulo

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical comparison between two surgical techniques with acellular dermal matrix graft in the treatment of gingival recessions

Study Record Dates

First Submitted

August 3, 2010

First Posted

August 5, 2010

Study Start

August 1, 2010

Primary Completion

June 1, 2011

Study Completion

October 1, 2011

Last Updated

November 16, 2011

Record last verified: 2011-11

Locations