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

September 26, 2023 updated by: Institute Franci

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

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).

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Italy
      • Padova, Italy, 35121
        • Recruiting
        • Franci Institute
        • Contact:
        • Sub-Investigator:
          • Enrico Corrà, DDS
        • Sub-Investigator:
          • Marco Toia, DDS
        • Principal Investigator:
          • Denis Cecchinato, MD-DDS
        • Sub-Investigator:
          • Eriberto Bressan, DDs
        • Sub-Investigator:
          • Jan Lindhe, Prof.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

25 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: bone grafting
The possibility of counteracting unfavourable ridge modelling after multiple tooth extractions by placing bone grafting material in the fresh extraction sites.
Device: Bone grafting
Sham Comparator: natural healing
ridge modelling after multiple tooth extractions.
Device: Bone grafting

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Up to 24 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
3 years follow up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Institute Franci

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2015

Primary Completion (Estimated)

September 1, 2023

Study Completion (Estimated)

September 1, 2023

Study Registration Dates

First Submitted

September 1, 2016

First Submitted That Met QC Criteria

September 12, 2016

First Posted (Estimated)

September 16, 2016

Study Record Updates

Last Update Posted (Actual)

September 28, 2023

Last Update Submitted That Met QC Criteria

September 26, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • G-2013-018

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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