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

Assistance Publique - Hôpitaux de Paris

Status and phase: Unknown; Phase 3; Phase 2

Conditions: Bone Substitute; Replacement Material; Alveolar Bone Loss; Denture Complete Immediate; Bone

Treatments: Device: Conventional protocol; Device: Bone substitute material group

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02120053

P111116

AOR12032 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 37 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

37 participants in 2 patient groups

Bone substitute material group

Experimental group

Description:

Immediate denture placement following extractions and alveolar sockets filling with bone substitute material

Treatment:

Device: Bone substitute material group

Conventional protocol

Active Comparator group

Description:

Immediate denture placement following the conventional protocol

Treatment:

Device: Conventional protocol