| Abstrakt: |
Two separate investigationswere undertaken to assess the clinical characteristics and the safety, and to determine whether an absorbable type 1 bovine collagen barrier membrane would result in the improvement of clinical parameters during guided tissue regeneration in humans. The collagen membrane barrier was placed over a total of 21 interdental intrabony periodontal defects in 18 patients. The surgical procedures and postsurgical regimen were similar in both components of the investigation. Sulcular incisions were used and the sites were surgically exposed by reflection of full thickness mucoperiosteal flaps. The intrabony defects were debrided and the root surfaces prepared with automatic sealers and curets. Four 1‐minute applications of tetracycline HCl 50 mg/ml were applied to the root surface. The collagen membrane barrier was hydrated in sterile saline until pliable, then trimmed so it covered the osseous defect and extended 2 to 3 mm beyond the defect. In both investigations, the collagen barrier membrane was not sutured, but retained by “pouching” or undermining the flap. Healing occurred without complications. There were no untoward or adverse reactions to the material in either phase of the study. In the initial investigation, 13 intrabony defects with probing depths of ≥ 5 mm were treated in 9 patients having a mean age of 50.6 years. No controls defects were treated. Soft and hard tissue measurements were taken at the time of initial surgery and at 2, 4, and 6 months. In the second phase, 9 patients were enrolled with a mean age of 49.7 years. They had similar bilateral interdental intrabony defects with probing depths ≥ 6 mm. One defect received the collagen membrane barrier, while the other was treated by flap debridement alone. The collagen membrane had undergone modification since the initial investigation, and was more highly cross‐linked to retard absorption. After initial therapy, and prior to the surgical procedure, a series of 3 dermal patch tests were used to determine whether the patient would elicit a reaction to the collagen. Venous blood was drawn at baseline, 7 to 10 days, 18 to 21 days and at 8 weeks for analysis by ELISA for comparison of test and control sites relative to baseline. There were no allergic response to the dermal tests, and the ELISA tests indicated no significant differences between test and control sites. An automated probe was used to record soft and hard tissue measurements. These included the probing depths and clinical attachment levels. Hard tissue measurements were taken from a stent to the base of the intrabony defect and from the alveolar crest to the base of the bony defect. Data collection was done at baseline, at subsequent examinations, and during the 12 month re‐entry. The results suggest the use of type I bovine collagen as a membrane barrier did not elicit adverse clinical reactions, enhanced the formation of new bone in intrabony defects, resulted in a gain of clinical attachment, and reduced probing depths. J Periodontol 1995;66:635–645. |
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