ORAL HEALTH EVIDENCE-BASED PRACTICE PROGRAM
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Title Acellular Dermal Matrix (AlloDerm) Employed in Palatal Fistula Repair May Improve the Rate of Fistula Closure
Clinical Question In patients with cleft palate, does AlloDerm improve postoperative fistula closure rate when compared with the conventional surgical technique (historical control)?
Clinical Bottom Line The use of AlloDerm may be of potential benefit in reducing fistula formation in cleft palate repair but statistically significant evidence is not available at this time.
Best Evidence (you may view more info by clicking on the PubMed ID link)
PubMed ID Author / Year Patient Group Study type
(level of evidence)
#1) 16374096Steele/200630 patients with palatal fistula repair as a result of failure of primary surgical palate repairCase Control Study
Key results30 patients undergoing palatal fistula repair were identified. 4 were excluded secondary to a prealveolar fistula location. 15 patients underwent repair by conventional techniques (Group 1), while 11 patients underwent repair using AlloDerm (Group 2). 3 patients from Group 1 and 2 patients from Group 2 were excluded due to loss to follow-up. Group 1 had 8 males and 4 females with an average age of 4.76 years (range, 15 months to 12 years), and Group 2 had 4 males and 5 females with an average age of 14.2 years (range, 3 months to 69.3 years). In Group 1, 10/12 patients (83.3%) obtained primary fistula closure. In Group 2, 9/9 (100%) patients obtained fistula closure. A statistically significant difference (83.3% versus 100%, P = 0.25) was not observed, which may be associated with a small sample size.
#2) 16877906Cole/20065 patients with oro-nasal fistulaCase Series
Key results5 patients who had previously undergone at least three prior palatal repairs with the recurrence of their oro-nasal fistula in the post-alveolar area were treated with interpositional AlloDerm placed between the nasal and oral mucosa. There were 4 males and 1 female with a median age of 33 months. Median length of follow-up was 7 months (range, 3 to 10 months). All 5 patients healed without adverse effects. This was not a randomized clinical trial.
Evidence Search (("Palatal"[text word]) AND "Fistula"[Mesh]) AND "Alloderm" [Supplementary Concept]
Comments on
The Evidence
Both studies were retrospective studies, and both included a small number of patients. The number of clinical trials, to date, involving AlloDerm and palatal fistula repair is few. Both studies showed that the use of AlloDerm was safe and effective; however, statistically significant reduction in failure rate was not noted compared to the conventional technique (historical control). Clinical trials with a larger patient population are required to determine statistical significance between the use of AlloDerm versus the control group.
Applicability AlloDerm is an acellular dermal matrix derived from human cadaver skin. It is immunologically inert with an intact basement membrane complex. It is composed of extracellular components including collagen, elastin, glycosaminoglycans, and vascular channels. It has a polarity by which one side of the material has a basal lamina for epithelial cells growth and the other side, an underlying porous dermal matrix, allowing for ingrowth of fibroblasts and angiogenic cells – providing an ideal scaffold for tissue ingrowth, revascularization, and mucosal epithelialization without any evidence of immunologic rejection or donor-site morbidity. After placement, the patient’s blood infiltrates the AlloDerm graft through retained vascular channels, bringing host cells that adhere to proteins in the matrix. The host cells respond to the local environment and the matrix is remodeled into the patient’s own tissue, in a fashion similar to the body’s natural tissue attrition and replacement process. AlloDerm is currently being used in dentistry as an oral soft tissue graft and is the most published acellular dermal matrix in implant dentistry. Its applications include root coverage, gingival augmentation, soft tissue ridge augmentation, and soft tissue augmentation around implants. AlloDerm is safe, easy to use and widely available. The main disadvantage is the associated cost. The evidence in this CAT is applicable to patients with palatoplasty and cleft palate repairs.
Specialty/Discipline (Oral Medicine/Pathology/Radiology) (Pediatric Dentistry)
Keywords Alloderm, acellular dermal graft, cleft palate, oro-nasal fistula, fistula
ID# 2887
Date of submission: 04/04/2015spacer
E-mail rakianr@livemail.uthscsa.edu
Author Rubie Rakian
Co-author(s)
Co-author(s) e-mail
Faculty mentor/Co-author Kevin J. Donly, DDS, MS
Faculty mentor/Co-author e-mail DONLY@uthscsa.edu
Basic Science Rationale
(Mechanisms that may account for and/or explain the clinical question, i.e. is the answer to the clinical question consistent with basic biological, physical and/or behavioral science principles, laws and research?)
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Comments on the CAT
(FOR PRACTICING DENTISTS' and/or FACULTY COMMENTS ON PUBLISHED CATs)
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