Interest of Bone Substitute Material in Immediate Complete Denture (PANORAMIX)
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.
|Alveolar Bone Loss Denture Complete Immediate Bone Substitute Replacement Material Bone||Device: Conventional protocol Device: Bone substitute material group||Phase 2 Phase 3|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||Interest of Bone Substitute Material in Immediate Complete Denture: a Controlled Randomized Clinical Trial|
- 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) ]
- 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
|Study Start Date:||October 2013|
|Estimated Study Completion Date:||April 2018|
|Estimated Primary Completion Date:||April 2016 (Final data collection date for primary outcome measure)|
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT02120053
|Contact: Christophe Rignon-Bret, DDS, PhD||1 49 81 33 33 ext +email@example.com|
|Henri Mondor Hospital||Recruiting|
|Creteil, France, 94010|
|Contact: Christophe Rignon-Bret, DDS, PhD 1 49 81 33 33 ext +33 firstname.lastname@example.org|
|Contact: Fatiha Djennaoui, CRA 1 49 81 33 84 ext +33 email@example.com|
|Principal Investigator: Christophe Rignon-Bret, DDS, PhD|
|Principal Investigator:||Christophe Rignon-Bret, DDS, PhD||Assistance Publique - Hôpitaux de Paris|