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

Primary Purpose

Gingival Recession

Status
Completed
Phase
Phase 2
Locations
Brazil
Study Type
Interventional
Intervention
acellular dermal matrix graft
enamel matrix derivative
Sponsored by
University of Sao Paulo
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Gingival Recession focused on measuring gingival recession, dental enamel proteins, acellular dermal matrix graft, tobacco

Eligibility Criteria

30 Years - 50 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • any systemic condition
  • daily drug intake
  • periodontal pockets associated with the gingival recessions or adjacent teeth

Sites / Locations

  • Department of Oral Surgery and Periodontology - Ribeirão Preto School of Dentistry, University of São Paulo

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

acellular dermal matrix graft

enamel matrix derivative

Arm Description

Outcomes

Primary Outcome Measures

Percentage of root coverage

Secondary Outcome Measures

Probing depth
relative clinical attachment level
gingival recession height
gingival recession width
keratinized tissue width
keratinized tissue thickness
complete root coverage

Full Information

First Posted
May 5, 2014
Last Updated
May 9, 2014
Sponsor
University of Sao Paulo
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1. Study Identification

Unique Protocol Identification Number
NCT02135471
Brief Title
Root Coverage in Smokers With Acellular Dermal Matrix Graft and Enamel Matrix Derivative
Official Title
A 12-month Randomised Controlled Prospective Clinical Study for Root Coverage in Smokers With Acellular Dermal Matrix Graft and Enamel Matrix Derivative
Study Type
Interventional

2. Study Status

Record Verification Date
May 2014
Overall Recruitment Status
Completed
Study Start Date
June 2009 (undefined)
Primary Completion Date
November 2011 (Actual)
Study Completion Date
November 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Sao Paulo

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
Detailed Description
The present clinical study was designed as a controlled, randomised split-mouth design. Twenty patients will be selected by an experienced periodontist responsible for the study at the Clinic of Periodontology, School of Dentistry of Ribeirão Preto - University of São Paulo (USP). 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. Radiographs will take to evaluate the interproximal alveolar bone level. Before beginning the active therapy, each patient will be randomised to a single treatment group (test or control) by using the method of randomly allocating by simple draw to reduce bias and equalize groups. The allocation was implemented by a senior investigator who will be not directly involved in the examination or treatment procedures. Using a split-mouth design, twenty patients with a total of 40 class I or II recession defects will be randomly allotted and treated either with acellular dermal matrix graft (ADMG) + enamel matrix derivative (EMD) (test group - TG) and the other side received only ADMG (control group - CG). The clinical parameters will be recorded at the selected and adjacent teeth, on both sides, with computerized periodontal probe two weeks after basic periodontal therapy (baseline) and twelve months after surgery by one-blinded experienced periodontist. A calibration exercise will be performed to achieve acceptable intraexaminer reproducibility (≥ 90%). The patients initially will complete a pre-surgical therapy - a program of plaque control was performed before and after surgery and scaling and root planning with curettes. The plaque and bleeding indices should be less than 20% at baseline. All risks and benefits involved in the surgical procedures will be explained to the patients before they signed a consent form in agreement. The methodology was approved by the Human Ethics Research Committee of the School of Dentistry of Ribeirão Preto - USP (process 2009.1.590.58.4/ 004.0.138.000-09). A modified surgical technique will be used in both groups, the flap is extended to adjacent teeth as a modification of the current subepithelial connective tissue graft technique (Langer & Langer, 1985). In the test group, an additional EMD layer will be inserted between the ADMG and the flap, and between the ADMG and the root surface by using a sterile brush. The prescribed medication will include 0.12% chlorhexidine digluconate solution to rinse twice a day for the first fifteen days, amoxicillin for seven days, starting 24 hours before surgery, and an analgesic for three days. Patients will continue to smoke as usual and will be instructed to avoid trauma and to discontinue tooth brushing at the surgical sites during fourteen days. The sutures will be removed after fourteen days. The patients will be recalled for control and prophylaxis after two and four weeks and, subsequently, once a month until the final examination.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gingival Recession
Keywords
gingival recession, dental enamel proteins, acellular dermal matrix graft, tobacco

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Crossover Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
19 (Actual)

8. Arms, Groups, and Interventions

Arm Title
acellular dermal matrix graft
Arm Type
Experimental
Arm Title
enamel matrix derivative
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
acellular dermal matrix graft
Other Intervention Name(s)
Alloderm
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
enamel matrix derivative
Other Intervention Name(s)
Emdogain
Intervention Description
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.
Primary Outcome Measure Information:
Title
Percentage of root coverage
Time Frame
twelve months
Secondary Outcome Measure Information:
Title
Probing depth
Time Frame
twelve months
Title
relative clinical attachment level
Time Frame
Twelve months
Title
gingival recession height
Time Frame
Twelve months
Title
gingival recession width
Time Frame
twelve months
Title
keratinized tissue width
Time Frame
twelve months
Title
keratinized tissue thickness
Time Frame
twelve months
Title
complete root coverage
Time Frame
twelve months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: any systemic condition daily drug intake periodontal pockets associated with the gingival recessions or adjacent teeth
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Arthur B Novaes, Professor
Organizational Affiliation
Department of Oral Surgery and Periodontology - Ribeirão Preto School of Dentistry, University of São Paulo
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Oral Surgery and Periodontology - Ribeirão Preto School of Dentistry, University of São Paulo
City
Ribeirão Preto
State/Province
São Paulo
ZIP/Postal Code
14040-904
Country
Brazil

12. IPD Sharing Statement

Citations:
PubMed Identifier
22409423
Citation
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.
Results Reference
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Root Coverage in Smokers With Acellular Dermal Matrix Graft and Enamel Matrix Derivative

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