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Interest of Bone Substitute Material in Immediate Complete Denture (PANORAMIX)

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02120053
First Posted: April 22, 2014
Last Update Posted: October 3, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Geistlich Pharma AG
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris
  Purpose

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.


Condition Intervention Phase
Alveolar Bone Loss Denture Complete Immediate Bone Substitute Replacement Material Bone Device: Conventional protocol Device: Bone substitute material group Phase 2 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Interest of Bone Substitute Material in Immediate Complete Denture: a Controlled Randomized Clinical Trial

Resource links provided by NLM:


Further study details as provided by Assistance Publique - Hôpitaux de Paris:

Primary Outcome Measures:
  • 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 Measures:
  • 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 ]
    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


Enrollment: 37
Study Start Date: October 2013
Estimated Study Completion Date: March 2018
Estimated Primary Completion Date: March 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Bone substitute material group
Immediate denture placement following extractions and alveolar sockets filling with bone substitute material
Device: Bone substitute material group
Teeth extractions and sockets filling with bone replacement material before immediate complete denture placement
Active Comparator: Conventional protocol
Immediate denture placement following the conventional protocol
Device: Conventional protocol
Teeth extractions and conventional immediate complete denture placement

  Eligibility

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02120053


Locations
France
Henri Mondor Hospital
Creteil, France, 94010
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Geistlich Pharma AG
Investigators
Principal Investigator: Christophe Rignon-Bret, DDS, PhD Assistance Publique - Hôpitaux de Paris
  More Information

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT02120053     History of Changes
Other Study ID Numbers: P111116
AOR12032 ( Other Identifier: APHP sponsor )
First Submitted: April 15, 2014
First Posted: April 22, 2014
Last Update Posted: October 3, 2017
Last Verified: September 2017

Keywords provided by Assistance Publique - Hôpitaux de Paris:
Immediate complete denture
Alveolar ridge resorption
Alveolar bone loss
Bone substitute material
Edentulism

Additional relevant MeSH terms:
Alveolar Bone Loss
Bone Resorption
Bone Diseases
Musculoskeletal Diseases
Periodontal Atrophy
Periodontal Diseases
Mouth Diseases
Stomatognathic Diseases