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

Not Applicable

Recruiting

• Conditions: Alveolar Ridge Trauma; Bone Resorption

• Registration Number: NCT02903667
• Lead Sponsor: Institute Franci

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 Description

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).

Study Timeline

• Study Start: 2015-03
• Study First Submitted: 2016-09-01
• Study First Submitted QC: 2016-09-12
• Study First Posted: 2016-09-16
• Status Verified: 2023-09
• Primary Completion: 2023-09
• Study Completion: 2023-09
• Last Update Submitted: 2023-09-26
• Last Update Posted: 2023-09-28

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

intact extraction sockets following removal of the natural teeth defined by:

• a marginal dehiscence defect of any of the facial bone walls of 3 mm
• no facial fenestration present in the apical of the marginal bone crest

Exclusion Criteria

• untreated rampant caries and uncontrolled periodontal disease
• uncontrolled diabetes or any other systemic or local disease or condition that would compromise post-operative healing
• unable or unwilling to return for follow-up or unlikely to be able to comply with study procedures according to investigators judgement.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Cone Beam Computerized Tomographic (CBCT) examination at the center of each extraction socket, between the sockets, at the septum next to adjacent teeth.	Up to 24 weeks	Measurements of alveolar ridge dimensional changes in the first 6 months of healing

Secondary Outcome Measures

Name	Time	Method
Standard intraoral radiograph of each experimental socket and inter-dental bone	3 years follow up	Changes in crestal bone level between baseline (prosthetic restoration) and follow-up (3 years later)

Trial Locations

Locations (1)

Franci Institute; 🇮🇹 Padova, Italy