Interest of Bone Substitute Material in Immediate Complete Denture

Alveolar Bone Loss Clinical Trial

— PANORAMIX  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02120053
• Other study ID #: P111116
• Secondary ID: AOR12032
• Status: Active, not recruiting
• Phase: Phase 2/Phase 3
• First received: April 15, 2014
• Last updated: October 2, 2017
• Start date: October 2013
• Est. completion date: March 2018

Study information

• Verified date: September 2017
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Alveolar Bone Loss
• Bone
• Bone Substitute
• Denture Complete Immediate
• Replacement Material

Intervention

Device:
• Conventional protocol
Teeth extractions and conventional immediate complete denture placement
• Bone substitute material group
Teeth extractions and sockets filling with bone replacement material before immediate complete denture placement

Locations

Country	Name	City	State
France	Henri Mondor Hospital	Creteil

Sponsors (2)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris	Geistlich Pharma AG

Country where clinical trial is conducted

France, 

References & Publications (5)

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

Outcome

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