PMID- 21808759 OWN - NLM STAT- MEDLINE DCOM- 20110830 LR - 20210227 IS - 1756-2406 (Print) IS - 1756-2406 (Linking) VI - 4 IP - 2 DP - 2011 Summer TI - Use of a new cross-linked collagen membrane for the treatment of peri-implant dehiscence defects: a randomised controlled double-blinded clinical trial. PG - 87-100 AB - PURPOSE: The aim of this randomised controlled double-blinded clinical trial was to determine the efficacy of a new cross-linked membrane (VN) in guided bone regeneration (GBR) around exposed dental implants compared to a native collagen membrane (BG). MATERIAL AND METHODS: A total of 16 patients in need of implant treatment at two different sites with osseous defects were planned for this split-mouth study. After inserting the dental implants, peri-implant defects were treated according to the GBR technique using a VN membrane with prolonged resorption time in the randomised test site and a BG membrane in the control site. After a healing time of 6 months, mucoperiosteal flaps were elevated for the evaluation of the primary (vertical bone fill [DeltaDL] and quality of newly formed tissue [QT]) and secondary outcome variables (infrabony defect height [DH], defect width [DW], defect depth [DD] and augmentation depth [AD]) and the sampling of biopsies apical to the implant shoulder. RESULTS: A total of 16 patients fulfilled the initial non-surgical inclusion and exclusion criteria. However, the study was discontinued early after 9 surgically treated patients because unacceptable safety issues arose and severe infection related to the VN membranes. The VN membrane revealed statistically significantly more soft tissue dehiscence than the BG membrane (56% and 11%, respectively, P = 0.0455). In 3 of these 9 patients the VN membrane had to be removed due to infection early after the first follow-up visit. For the statistical analyses these sites were designated as the value of the baseline. The mean DeltaDL values were 1.8 +/- 1.6 mm at the VN site and 4.7 +/- 3.3 mm at the BG site. The DeltaDD values were 0.6 +/- 1.0 mm and 1.1 +/- 1.2 mm, respectively, and reached statistical significance (P = 0.0208, CI 95% = -2.9 [-5.2;-0.6]). The corresponding linear defect fill (DF) values were 44% and 78%, respectively. The clinical assessment of QT showed comparable median values at sites treated with VN (3, interquartile range: 0; 3.5) and BG (3, interquartile range: 3; 4) without statistical significance. The histomorphometric analysis showed an average area density of 24.4% (SD 10.3, range 8-35%) newly formed bone at the test sites and of 35.0% (SD 20.6, range 8-60%) at the control sites. The histological data showed only some trends and did not reach statistical significance. CONCLUSION: In the present study, the VN membranes with prolonged resorption time demonstrated significantly more adverse events and insufficient bone regeneration compared to the native BG membranes and no advantages in favour of the VN membranes were detectable. FAU - Annen, Beat Martin AU - Annen BM AD - Center of Dental Medicine, University of Zurich, Switzerland. FAU - Ramel, Christian Felix AU - Ramel CF FAU - Hammerle, Christoph Hans AU - Hammerle CH FAU - Jung, Ronald Ernst AU - Jung RE LA - eng PT - Journal Article PT - Randomized Controlled Trial PL - England TA - Eur J Oral Implantol JT - European journal of oral implantology JID - 101473719 RN - 0 (Bio-Oss) RN - 0 (Bone Substitutes) RN - 0 (Membranes, Artificial) RN - 0 (Minerals) RN - 9007-34-5 (Collagen) SB - IM MH - Absorbable Implants/*adverse effects MH - Adult MH - Alveolar Bone Loss/etiology/*surgery MH - Bone Regeneration MH - Bone Substitutes MH - Collagen/adverse effects/*chemistry MH - *Dental Implantation, Endosseous/adverse effects MH - Double-Blind Method MH - Early Termination of Clinical Trials MH - Female MH - Guided Tissue Regeneration, Periodontal/*methods MH - Humans MH - Male MH - *Membranes, Artificial MH - Middle Aged MH - Minerals MH - Statistics, Nonparametric MH - Surgical Wound Dehiscence/etiology/surgery MH - Surgical Wound Infection/etiology EDAT- 2011/08/03 06:00 MHDA- 2011/08/31 06:00 CRDT- 2011/08/03 06:00 PHST- 2011/08/03 06:00 [entrez] PHST- 2011/08/03 06:00 [pubmed] PHST- 2011/08/31 06:00 [medline] AID - 855658 [pii] PST - ppublish SO - Eur J Oral Implantol. 2011 Summer;4(2):87-100.