Alveolar Bone Loss, Denture Complete Immediate, Bone Substitute, Replacement Material, Bone
Conditions
Keywords
Immediate complete denture, Alveolar ridge resorption, Alveolar bone loss, Bone substitute material, Edentulism
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.
Interventions
DEVICEConventional protocol
Teeth extractions and conventional immediate complete denture placement
DEVICEBone substitute material group
Teeth extractions and sockets filling with bone replacement material before immediate complete denture placement
Sponsors
Geistlich Pharma AG
Assistance Publique - Hôpitaux de Paris
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| 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 | one year (365 days) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
France
Outcome results
None listed