Interest of Bone Substitute Material in Immediate Complete Denture (PANORAMIX)

October 2, 2017 updated by: Assistance Publique - Hôpitaux de Paris

Interest of Bone Substitute Material in Immediate Complete Denture: a Controlled Randomized Clinical Trial

More than 2 million French people suffer from the widespread disability of edentulism, with large consequences on function, nutrition, aesthetics and well-being. Complete denture is a common therapeutic strategy.

The immediate complete denture technique consists in placing the denture in the same clinical session as last anterior teeth extractions. With this technique, aesthetic and function are immediately reintroduced and the patient is never left toothless or without any denture.

After teeth extractions, alveolar healing process leads to ridge resorption with bone volume modifications and reduction in height and width.

However ridge bone volume is an essential factor in removable denture stability. With implantology as an alternative prosthetic strategy, ridge volume is also a most important factor to place dental implants in a situation close to previous dental roots position. In order to preserve bone volume, a current alternative strategy proposes to place bone substitute materials in tooth sockets after extraction. This strategy was never evaluated with the immediate complete denture technique.

Hypothesis: A new strategy associating immediate complete denture and bone substitute material is more effective than conventional immediate complete denture in a bone preservation perspective.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

37

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

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

Study Locations

  • France
      • Creteil, France, 94010
        • Henri Mondor Hospital

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Candidates for maxillary immediate complete denture, presenting a Kennedy
  • Class I partial dentition (bilateral posterior tooth loss)
  • Over 18 years of age
  • Healthy adhering gingiva
  • Willing to participate in the study, able to sign the consent form

Exclusion Criteria:

- Medical conditions contraindicating oral surgery: progressive cancer history of radiotherapy in the head and neck region major neurological disease anti-coagulant treatment with prothrombin time<30% valvulopathy, hematologic disease, agranulocytosis, serious heart failure, recent myocardial infarction < 5 years immune deficiency, AIDES osteomalacia hepatic or renal insufficiency unregulated diabetes long-term steroids treatment bisphosphonates

  • Allergy to collagen
  • Pregnant or nursing women
  • Persons specially protected
  • Non-affiliated with the social security system persons

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 substitute material group
Immediate denture placement following extractions and alveolar sockets filling with bone substitute material
Device: Bone substitute material group
Teeth extractions and sockets filling with bone replacement material before immediate complete denture placement
Active Comparator: Conventional protocol
Immediate denture placement following the conventional protocol
Device: Conventional protocol
Teeth extractions and conventional immediate complete denture placement

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Comparison of bone ridge height one year after maxillary immediate complete denture placement with or without bone substitute material in incisive-canine sockets
Time Frame: one year (365 days)
one year (365 days)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Height and width average between day 10th and day 90th after maxillary immediate complete denture placement, and between day 10th and one year
Time Frame: Day 10, Day 90, Day 365
To compare bone ridge width one year after maxillary immediate complete denture placement with and without bone substitute material in incisive-canine sockets: height and width average between day 10th and day 90th after maxillary immediate complete denture placement, and between day 10th and one year
Day 10, Day 90, Day 365

Collaborators and Investigators

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

Sponsor

Assistance Publique - Hôpitaux de Paris

Collaborators

Geistlich Pharma AG

Investigators

  • Principal Investigator: Christophe Rignon-Bret, DDS, PhD, Assistance Publique - Hôpitaux de Paris

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

October 1, 2013

Primary Completion (Anticipated)

March 1, 2018

Study Completion (Anticipated)

March 1, 2018

Study Registration Dates

First Submitted

April 15, 2014

First Submitted That Met QC Criteria

April 18, 2014

First Posted (Estimate)

April 22, 2014

Study Record Updates

Last Update Posted (Actual)

October 3, 2017

Last Update Submitted That Met QC Criteria

October 2, 2017

Last Verified

September 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • P111116
  • AOR12032 (Other Identifier: APHP sponsor)

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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