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Root Coverage in Smokers With Acellular Dermal Matrix Graft and Enamel Matrix Derivative

NCT02135471 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 19

Last updated 2014-05-12

No results posted yet for this study

Summary

Smoking has a negative effect on the predictability and stability of root coverage procedures because of decreased blood supply and fibroblast activity. Long-term evaluation of this procedure in smokers is important for clinical decision making, because it provides information about the stability of results over time. In smokers, enamel matrix derivative (EMD) used at acellular dermal matrix graft (ADMG)/ soft tissue interface could be an alternative to improve the deficient healing potential, since EMD has the capability of stimulating angiogenesis. At the ADMG/ root surface interface, it could improve the deficient fibroblast activity in smokers and therefore reduce the presence of a long junctional epithelium. The aim of this randomised controlled clinical study was to investigate whether EMD contributes to the root coverage of gingival recessions performed with ADMG in smokers during a 12-month follow-up.

Twenty smokers with bilateral Miller Class I or II gingival recessions ≥ 3 mm will be selected. The test group will be treated with an association of ADMG and EMD, and the control group with ADMG alone. Some clinical parameters as: probing depth, relative clinical attachment level, gingival recession height, gingival recession width, keratinized tissue width and keratinized tissue thickness will be evaluated before surgery and after twelve months.

Conditions

  • Gingival Recession

Interventions

DRUG

acellular dermal matrix graft

On one side, the previously reflected partial-thickness flaps will be coronally positioned to entirely cover the acellular dermal matrix graft (ADMG), and also sutured with sling sutures using 6-0 bioabsorbable sutures.

DRUG

enamel matrix derivative

On the other side, the same procedure will be performed, with an additional layer of enamel matrix derivative between the acellular dermal matrix graft (ADMG) and the flap, and between the ADMG and the root surface by using a sterile brush.

Sponsors & Collaborators

  • University of Sao Paulo

    lead OTHER

Principal Investigators

  • Arthur B Novaes, Professor · Department of Oral Surgery and Periodontology - Ribeirão Preto School of Dentistry, University of São Paulo

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
CROSSOVER

Eligibility

Min Age
30 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-06-30
Primary Completion
2011-11-30
Completion
2012-11-30

Countries

  • Brazil

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02135471 on ClinicalTrials.gov