Interest of Bone Substitute Material in Immediate Complete Denture

Study Overview
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Brief Summary
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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.

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

Conditions
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Alveolar Bone Loss, Denture Complete Immediate, Bone Substitute, Replacement Material, Bone

Intervention / Treatment
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* Device: Conventional protocol
* Device: Bone substitute material group


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Bone substitute material group<br>Immediate denture placement following extractions and alveolar sockets filling with bone substitute material | Device: Bone substitute material group<br>* Teeth extractions and sockets filling with bone replacement material before immediate complete denture placement<br>|
| Active Comparator: Conventional protocol<br>Immediate denture placement following the conventional protocol | Device: Conventional protocol<br>* Teeth extractions and conventional immediate complete denture placement<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 |  | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Immediate complete denture, Alveolar ridge resorption, Alveolar bone loss, Bone substitute material, Edentulism