Root Coverage in Smokers With Acellular Dermal Matrix Graft and Enamel Matrix Derivative
Condition: Gingival Recession
MeSH terms: Gingival Recession
Study type: Interventional
Phase: Phase 2

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.
    

Intervention name(s): acellular dermal matrix graft; enamel matrix derivative
Intervention type(s): Drug; Drug
Intervention description(s): 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.
Other intervention name(s): Alloderm; Emdogain
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: gingival recession; dental enamel proteins; acellular dermal matrix graft; tobacco