Clinical Trial: Biomaterial to Counteract Ridge Reduction Following the Removal of Multiple Adjacent Teeth.

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Biomaterial to Counteract Ridge Reduction Following the Removal of Multiple Adjacent Teeth. A Prospective Randomized Controlled Study.

Brief Summary: An open, prospective, randomized, multicenter study focused on the ridge diminution in case of grafting of fresh extraction sockets with Bio-Oss Collagen, Bio-Gide (Geistlich Pharma, Wolhusen, Switzerland), placing Dentsply implants (Astra Tech System).

Detailed Summary: The removal of at least 2 adjacent teeth would cause more advanced hard tissue loss during healing than that occurring after removal of a single tooth with adjacent teeth present. In order to maintain the dimension of the ridge following tooth removal, bone grafts and bone substitutes have also been placed in the extraction socket. So far no data have been reported on the effect of removal of multiple adjacent teeth on bone loss at various aspects of the edentulous sites. Furthermore, the potential effect on ridge contraction of implant placement in multiple fresh extraction sites is not documented. Therefore, the objective of the study is to evaluate the possibility of counteracting un favourable ridge modeling after multiple tooth extractions by placing mineral bovine bone in the extraction sockets and covering the wound with a native collagen membrane. In addition, the possibility of placing implants in the grafted sites is evaluated after six month of healing. For these purpose 40 subjects with 2 or more fresh adjacent extraction sites in need of two or more implants replacing teeth will be enrolled. Ridge dimensional changes will be measured after 6 months of healing; marginal bone loss will be measured after 3-years follow-up from the baseline (prosthetic delivery).
Sponsor: Institute Franci

Current Primary Outcome: Cone Beam Computerized Tomographic (CBCT) examination at the center of each extraction socket, between the sockets, at the septum next to adjacent teeth. [ Time Frame: Up to 24 weeks ]

Measurements of alveolar ridge dimensional changes in the first 6 months of healing


Original Primary Outcome: Same as current

Current Secondary Outcome: Standard intraoral radiograph of each experimental socket and inter-dental bone [ Time Frame: 3 years follow up ]

Changes in crestal bone level between baseline (prosthetic restoration) and follow-up (3 years later)


Original Secondary Outcome: Same as current

Information By: Institute Franci

Dates:
Date Received: September 1, 2016
Date Started: March 2015
Date Completion: March 2021
Last Updated: September 12, 2016
Last Verified: September 2016