Alveolar Bone Loss Clinical Trial
— PANORAMIXOfficial title:
Interest of Bone Substitute Material in Immediate Complete Denture: a Controlled Randomized Clinical Trial
Verified date | September 2017 |
Source | Assistance Publique - Hôpitaux de Paris |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Active, not recruiting |
Enrollment | 37 |
Est. completion date | March 2018 |
Est. primary completion date | March 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
France | Henri Mondor Hospital | Creteil |
Lead Sponsor | Collaborator |
---|---|
Assistance Publique - Hôpitaux de Paris | Geistlich Pharma AG |
France,
Araújo MG, Liljenberg B, Lindhe J. Dynamics of Bio-Oss Collagen incorporation in fresh extraction wounds: an experimental study in the dog. Clin Oral Implants Res. 2010 Jan;21(1):55-64. doi: 10.1111/j.1600-0501.2009.01854.x. — View Citation
Lekovic V, Kenney EB, Weinlaender M, Han T, Klokkevold P, Nedic M, Orsini M. A bone regenerative approach to alveolar ridge maintenance following tooth extraction. Report of 10 cases. J Periodontol. 1997 Jun;68(6):563-70. — View Citation
Park JB. Healing of extraction socket grafted with deproteinized bovine bone and acellular dermal matrix: histomorphometric evaluation. Implant Dent. 2010 Aug;19(4):307-13. doi: 10.1097/ID.0b013e3181e5abbc. — View Citation
Rignon-Bret C, Rignon-Bret JM. Prothèse amovible complète, prothèse immédiate, prothèse supra-radiculaire et implantaire. Ed CdP, Collection JPIO 2002.
Tallgren A, Lang BR, Walker GF, Ash MM Jr. Roentgen cephalometric analysis of ridge resorption and changes in jaw and occlusal relationships in immediate complete denture wearers. J Oral Rehabil. 1980 Jan;7(1):77-94. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | 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 |
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