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

Primary Purpose

Alveolar Bone Loss, Denture Complete Immediate, Bone Substitute

Status
Unknown status
Phase
Phase 2
Locations
France
Study Type
Interventional
Intervention
Conventional protocol
Bone substitute material group
Sponsored by
Assistance Publique - Hôpitaux de Paris
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Alveolar Bone Loss focused on measuring Immediate complete denture, Alveolar ridge resorption, Alveolar bone loss, Bone substitute material, Edentulism

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Henri Mondor Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Bone substitute material group

Conventional protocol

Arm Description

Immediate denture placement following extractions and alveolar sockets filling with bone substitute material

Immediate denture placement following the conventional protocol

Outcomes

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

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
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

Full Information

First Posted
April 15, 2014
Last Updated
October 2, 2017
Sponsor
Assistance Publique - Hôpitaux de Paris
Collaborators
Geistlich Pharma AG
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1. Study Identification

Unique Protocol Identification Number
NCT02120053
Brief Title
Interest of Bone Substitute Material in Immediate Complete Denture
Acronym
PANORAMIX
Official Title
Interest of Bone Substitute Material in Immediate Complete Denture: a Controlled Randomized Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
September 2017
Overall Recruitment Status
Unknown status
Study Start Date
October 2013 (undefined)
Primary Completion Date
March 2018 (Anticipated)
Study Completion Date
March 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Assistance Publique - Hôpitaux de Paris
Collaborators
Geistlich Pharma AG

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alveolar Bone Loss, Denture Complete Immediate, Bone Substitute, Replacement Material, Bone
Keywords
Immediate complete denture, Alveolar ridge resorption, Alveolar bone loss, Bone substitute material, Edentulism

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
37 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Bone substitute material group
Arm Type
Experimental
Arm Description
Immediate denture placement following extractions and alveolar sockets filling with bone substitute material
Arm Title
Conventional protocol
Arm Type
Active Comparator
Arm Description
Immediate denture placement following the conventional protocol
Intervention Type
Device
Intervention Name(s)
Conventional protocol
Intervention Description
Teeth extractions and conventional immediate complete denture placement
Intervention Type
Device
Intervention Name(s)
Bone substitute material group
Intervention Description
Teeth extractions and sockets filling with bone replacement material before immediate complete denture placement
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
Height and width average between day 10th and day 90th after maxillary immediate complete denture placement, and between day 10th and one year
Description
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
Time Frame
Day 10, Day 90, Day 365

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christophe Rignon-Bret, DDS, PhD
Organizational Affiliation
Assistance Publique - Hôpitaux de Paris
Official's Role
Principal Investigator
Facility Information:
Facility Name
Henri Mondor Hospital
City
Creteil
ZIP/Postal Code
94010
Country
France

12. IPD Sharing Statement

Citations:
PubMed Identifier
9203100
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. doi: 10.1902/jop.1997.68.6.563.
Results Reference
background
PubMed Identifier
6987348
Citation
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. doi: 10.1111/j.1365-2842.1980.tb01466.x.
Results Reference
background
PubMed Identifier
20683287
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.
Results Reference
background
PubMed Identifier
20070748
Citation
Araujo 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.
Results Reference
background
Citation
Rignon-Bret C, Rignon-Bret JM. Prothèse amovible complète, prothèse immédiate, prothèse supra-radiculaire et implantaire. Ed CdP, Collection JPIO 2002.
Results Reference
background
PubMed Identifier
27206923
Citation
Rignon-Bret C, Hadida A, Aidan A, Nguyen TH, Pasquet G, Fron-Chabouis H, Wulfman C. Efficacy of bone substitute material in preserving volume when placing a maxillary immediate complete denture: study protocol for the PANORAMIX randomized controlled trial. Trials. 2016 May 20;17(1):255. doi: 10.1186/s13063-016-1380-7.
Results Reference
derived

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Interest of Bone Substitute Material in Immediate Complete Denture

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