Evaluation of the safety and efficacy of periodontal applications of a living tissue-engineered human fibroblast-derived dermal substitute. II. Comparison to the subepithelial connective tissue graft: a randomized controlled feasibility study.

摘要

BACKGROUND: The subepithelial connective tissue graft, traditionally harvested from the patient's palate, is commonly used for root coverage in periodontal recession defects. This study evaluates the safety and effectiveness of a living human fibroblast-derived dermal substitute (HF-DDS) compared to a connective tissue graft (CTG) for root coverage in these situations. METHODS: Thirteen patients were selected for this study. Each patient had Miller Class I or II bilateral facial recession defects > or =3 mm on two non-adjacent teeth. The test tooth received an HF-DDS graft, while a CTG was placed on the control site. The 10 test surgeries were performed by one operator and three pilot surgeries were performed by another surgeon. Eight of the HF-DDS sites received a single thickness of material; five received a double thickness. Clinical measurements were taken at baseline; 1 week; and 1, 3, and 6 months following surgery. Parameters measured were plaque index, recession depth, clinical attachment levels, recession width, probing depth, and width of keratinized tissue. All clinical readings were taken by a masked, calibrated examiner. RESULTS: There were no statistically significant differences between the test and control groups. The amount of root coverage was slightly greater for the control group than for the test group, but statistically the difference was insignificant. The width of the recession defect measured at the cemento-enamel junction (CEJ) for the test group was slightly smaller than that of the control group at the conclusion of the study. The amount of keratinized tissue was the same in both groups at 6 months. The probing depth was slightly greater in the control group as was the gain in clinical attachment, but neither was statistically significant. The amount of root coverage obtained when one layer of HF-DDS was used compared to the amount of coverage obtained when two layers were used approached statistical significance, but the small sample size may have been responsible for the difference. CONCLUSION: Within the limits of this study, the human fibroblast-derived dermal substitute may offer potential as a substitute to the connective tissue graft for covering areas of facial Miller Class I or Class II gingival recession in humans.