Clinical trial NCT02903667: Biomaterial to Counteract Ridge Reduction Following the Removal of Multiple Adjacent Teeth.
Official title: Biomaterial to Counteract Ridge Reduction Following the Removal of Multiple Adjacent Teeth. A Prospective Randomized Controlled Study.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Alveolar Ridge Trauma
Bone Resorption
Keywords: bone grafting
implantology
oral surgery
Lead sponsor: Institute Franci
Sponsor class: OTHER
First posted: 2016-09-16
Enrollment: 40
Sex: ALL
Minimum age (years): 25
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

Eligibility criteria: 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.

Primary outcomes:
measure: Cone Beam Computerized Tomographic (CBCT) examination at the center of each extraction socket, between the sockets, at the septum next to adjacent teeth.
timeFrame: Up to 24 weeks
Secondary outcomes:
measure: Standard intraoral radiograph of each experimental socket and inter-dental bone
timeFrame: 3 years follow up
Other outcomes:
Locations:
city: Padova
country: Italy
facility: Franci Institute
Study officials:
References: