Interest of Bone Substitute Material in Immediate Complete Denture

• Register: ClinicalTrials.gov
• Last refreshed on: 16 December 2017
• Main ID: NCT02120053
• Date of registration: 15/04/2014
• Prospective Registration: No
• Primary sponsor: Assistance Publique - Hôpitaux de Paris
• Public title: Interest of Bone Substitute Material in Immediate Complete Denture PANORAMIX
• Scientific title: Interest of Bone Substitute Material in Immediate Complete Denture: a Controlled Randomized Clinical Trial
• Date of first enrolment: October 2013
• Target sample size: 37
• Recruitment status: Active, not recruiting
• URL: https://clinicaltrials.gov/show/NCT02120053
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Single (Outcomes Assessor).
• Phase: Phase 2/Phase 3

Countries of recruitment

France

Contacts

• Name: Christophe Rignon-Bret, DDS, PhD
• Affiliation: Assistance Publique - Hôpitaux de Paris

Key inclusion & exclusion criteria

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



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Replacement Material

Alveolar Bone Loss

Denture Complete Immediate

Bone

Bone Substitute

Intervention(s)

Device: Bone substitute material group

Device: Conventional protocol

Primary Outcome(s)

Comparison of bone ridge height one year after maxillary immediate complete denture placement with or without bone substitute material in incisive-canine sockets [Time Frame: one year (365 days)]

Secondary Outcome(s)

Height and width average between day 10th and day 90th after maxillary immediate complete denture placement, and between day 10th and one year [Time Frame: Day 10, Day 90, Day 365]

Secondary ID(s)

AOR12032

P111116

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Geistlich Pharma AG