Interest of Bone Substitute Material in Immediate Complete Denture

Phase 2

• Conditions: Replacement Material; Bone Substitute; Alveolar Bone Loss; Bone; Denture Complete Immediate
• Interventions: Device: Bone substitute material group; Device: Conventional protocol

• Registration Number: NCT02120053
• Lead Sponsor: Assistance Publique - Hôpitaux de Paris

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-10
• Study First Submitted: 2014-04-15
• Study First Submitted QC: 2014-04-18
• Study First Posted: 2014-04-22
• Status Verified: 2017-09
• Last Update Submitted: 2017-10-02
• Last Update Posted: 2017-10-03
• Primary Completion: 2018-03
• Study Completion: 2018-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 37

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Bone substitute material group	Bone substitute material group	Immediate denture placement following extractions and alveolar sockets filling with bone substitute material
Conventional protocol	Conventional protocol	Immediate denture placement following the conventional protocol

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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	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

Trial Locations

Locations (1)

Henri Mondor Hospital; 🇫🇷 Creteil, France