NCT02120053

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
37

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Oct 2013

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2013

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

April 15, 2014

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 22, 2014

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2018

Completed
Last Updated

October 3, 2017

Status Verified

September 1, 2017

Enrollment Period

4.4 years

First QC Date

April 15, 2014

Last Update Submit

October 2, 2017

Conditions

Alveolar Bone LossDenture Complete ImmediateBone SubstituteReplacement MaterialBone

Keywords

Immediate complete dentureAlveolar ridge resorptionAlveolar bone lossBone substitute materialEdentulism

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • 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

Study Arms (2)

Bone substitute material group

EXPERIMENTAL

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

Device: Bone substitute material group

Conventional protocol

ACTIVE COMPARATOR

Immediate denture placement following the conventional protocol

Device: Conventional protocol

Interventions

Conventional protocolDEVICE

Teeth extractions and conventional immediate complete denture placement

Conventional protocol
Bone substitute material groupDEVICE

Teeth extractions and sockets filling with bone replacement material before immediate complete denture placement

Bone substitute material group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • \- 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Henri Mondor Hospital

Créteil, 94010, France

Location

Related Publications (6)

  • 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.

    PMID: 9203100BACKGROUND

  • 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.

    PMID: 6987348BACKGROUND

  • 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.

    PMID: 20683287BACKGROUND

  • 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.

    PMID: 20070748BACKGROUND

  • Rignon-Bret C, Rignon-Bret JM. Prothèse amovible complète, prothèse immédiate, prothèse supra-radiculaire et implantaire. Ed CdP, Collection JPIO 2002.

    BACKGROUND

  • 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.

    PMID: 27206923DERIVED

MeSH Terms

Conditions

Alveolar Bone Loss

Condition Hierarchy (Ancestors)

Bone ResorptionBone DiseasesMusculoskeletal DiseasesPeriodontal AtrophyPeriodontal DiseasesMouth DiseasesStomatognathic Diseases

Study Officials

  • Christophe Rignon-Bret, DDS, PhD

    Assistance Publique - Hôpitaux de Paris

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 15, 2014

First Posted

April 22, 2014

Study Start

October 1, 2013

Primary Completion

March 1, 2018

Study Completion

March 1, 2018

Last Updated

October 3, 2017

Record last verified: 2017-09

Locations

FR(1)