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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-03-31

Study Completion Date

2023-09-30

Brief Summary

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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).

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Detailed Description

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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).

Conditions

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Alveolar Ridge Trauma Bone Resorption

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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bone grafting

The possibility of counteracting unfavourable ridge modelling after multiple tooth extractions by placing bone grafting material in the fresh extraction sites.

Group Type EXPERIMENTAL

Bone grafting

Intervention Type DEVICE

natural healing

ridge modelling after multiple tooth extractions.

Group Type SHAM_COMPARATOR

Bone grafting

Intervention Type DEVICE

Interventions

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Bone grafting

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* 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.

Minimum Eligible Age

25 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No