NCT02423473

Brief Summary

The aim of the present study is to evaluate the clinical, aesthetic and patient-centered parameters of connective tissue graft associated or not with composite resin for the treatment of gingival recession.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
36

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2011

Longer than P75 for not_applicable

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, 2011

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2014

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2015

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

April 3, 2015

Completed
19 days until next milestone

First Posted

Study publicly available on registry

April 22, 2015

Completed
Last Updated

April 23, 2015

Status Verified

April 1, 2015

Enrollment Period

3.2 years

First QC Date

April 3, 2015

Last Update Submit

April 22, 2015

Conditions

Gingival Recession

Outcome Measures

Primary Outcomes (1)

  • Percentage of defect coverage

    1 year

Secondary Outcomes (1)

  • Root coverage esthetic score

    1 year

Study Arms (2)

Connective tissue graft (CTG)

ACTIVE COMPARATOR

After local anesthesia, the surgical procedure performed was the trapezoidal-type of CAF (de Sanctis \& Zucchelli, 2007). After the flap was raised, the exposed root surface was gently scaled and planed until it became smooth. Afterward, a thin and small connective tissue graft that was sutured over the root surface. Then, the flap was coronally positioned and sutured to completely cover the graft.

Procedure: Connective tissue graft

Connective tissue graft plus composite resin restoration.

EXPERIMENTAL

After local anesthesia, the surgical procedure performed was the trapezoidal-type of CAF (de Sanctis \& Zucchelli, 2007). After the flap was raised, a sterile rubber dam was placed to isolate the operative field and the non-carious cervical lesion restoration was performed with a nanocomposite resin (Filtek Supreme - 3M ESPE - St. Paul, MN, USA), following the manufacturer's instructions. Afterward, a thin and small connective tissue graft that was sutured over the restoration surface. Then, the flap was coronally positioned and sutured to completely cover the graft.

Procedure: Connective tissue graftProcedure: Composite resin restoration (Filtek Supreme - 3M)

Interventions

Connective tissue graftPROCEDURE

Periodontal surgical technique to treat gingival recessions

Also known as: Periodontal plastic surgery
Connective tissue graft (CTG)Connective tissue graft plus composite resin restoration.
Composite resin restoration (Filtek Supreme - 3M)PROCEDURE

Restorative procedure do treat tooth structure loss

Also known as: Non-carious cervical lesion restoration
Connective tissue graft plus composite resin restoration.

Eligibility Criteria

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

You may qualify if:

  • presenting Miller class I or II gingival recession in the maxillary canines or premolars associated with non-carious cervical lesion;
  • teeth included in the study should present pulp vitality;
  • patients presenting no signs of active periodontal disease and full-mouth plaque and bleeding score ≤ 20%;
  • patients older than 18 years old;
  • probing depth ˂ 3 mm in the included teeth;
  • patients who agreed to participate and signed an informed consent form

You may not qualify if:

  • patients with systemic problems (cardiovascular, blood dyscrasias, immunodeficiency, and diabetes, among others) that will contraindicate the surgical procedure
  • patients taking medications known to interfere with the wound healing process or that contraindicate the surgical procedure
  • smokers or pregnant women
  • patients who underwent periodontal surgery in the area of interest; and

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Santamaria MP, da Silva Feitosa D, Casati MZ, Nociti FH Jr, Sallum AW, Sallum EA. Randomized controlled clinical trial evaluating connective tissue graft plus resin-modified glass ionomer restoration for the treatment of gingival recession associated with non-carious cervical lesion: 2-year follow-up. J Periodontol. 2013 Sep;84(9):e1-8. doi: 10.1902/jop.2013.120447. Epub 2013 Jan 31.

    PMID: 23368948BACKGROUND

MeSH Terms

Conditions

Gingival Recession

Interventions

Filtek Supreme

Condition Hierarchy (Ancestors)

Gingival DiseasesPeriodontal DiseasesMouth DiseasesStomatognathic DiseasesPeriodontal Atrophy

Study Officials

  • Mauro P Santamaria, PhD

    ICT-UNESP

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

April 3, 2015

First Posted

April 22, 2015

Study Start

August 1, 2011

Primary Completion

October 1, 2014

Study Completion

February 1, 2015

Last Updated

April 23, 2015

Record last verified: 2015-04