Root Coverage in Smokers With Acellular Dermal Matrix Graft and Enamel Matrix Derivative
A 12-month Randomised Controlled Prospective Clinical Study for Root Coverage in Smokers With Acellular Dermal Matrix Graft and Enamel Matrix Derivative
1 other identifier
interventional
19
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2
Started Jun 2009
Typical duration for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2012
CompletedFirst Submitted
Initial submission to the registry
May 5, 2014
CompletedFirst Posted
Study publicly available on registry
May 12, 2014
CompletedMay 12, 2014
May 1, 2014
2.4 years
May 5, 2014
May 9, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Percentage of root coverage
twelve months
Secondary Outcomes (7)
Probing depth
twelve months
relative clinical attachment level
Twelve months
gingival recession height
Twelve months
gingival recession width
twelve months
keratinized tissue width
twelve months
- +2 more secondary outcomes
Study Arms (2)
acellular dermal matrix graft
EXPERIMENTALenamel matrix derivative
EXPERIMENTALInterventions
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.
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.
Eligibility Criteria
You may qualify if:
- smokers (consuming 10 or more cigarettes/ day, for over five years)
- The subjects should have bilateral large, Miller (1985) Class I or II, ≥ 3 mm maxillary or mandibular gingival recession in non-molar teeth of different quadrants and in the same dental arch.
You may not qualify if:
- any systemic condition
- daily drug intake
- periodontal pockets associated with the gingival recessions or adjacent teeth
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Department of Oral Surgery and Periodontology - Ribeirão Preto School of Dentistry, University of São Paulo
Ribeirão Preto, São Paulo, 14040-904, Brazil
Related Publications (1)
Alves LB, Costa PP, Scombatti de Souza SL, de Moraes Grisi MF, Palioto DB, Taba M Jr, Novaes AB Jr. Acellular dermal matrix graft with or without enamel matrix derivative for root coverage in smokers: a randomized clinical study. J Clin Periodontol. 2012 Apr;39(4):393-9. doi: 10.1111/j.1600-051X.2012.01851.x. Epub 2012 Feb 5.
PMID: 22409423BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Arthur B Novaes, Professor
Department of Oral Surgery and Periodontology - Ribeirão Preto School of Dentistry, University of São Paulo
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Titular Professor of Department of Oral Surgery and Periodontology
Study Record Dates
First Submitted
May 5, 2014
First Posted
May 12, 2014
Study Start
June 1, 2009
Primary Completion
November 1, 2011
Study Completion
November 1, 2012
Last Updated
May 12, 2014
Record last verified: 2014-05