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OpenTrials
Completed

NCT Number: NCT02903667

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

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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Key information

Age range

25 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Franci Institute

Padova, 35121, Italy

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Bone grafting

Device

Primary outcomes

  1. 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

Secondary outcomes

  1. 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)

Sponsors and collaborators

Lead sponsor

Institute Franci

Other

Registry information

Official study title

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

Acronym: Biomaterial

Important dates

Study start
2015
Primary completion
2023
Study completion
2023
First posted
Sep 16, 2016
Registry last updated
Nov 19, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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