Clinical Trials Logo

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
Health authority
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

Study Design


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
See also
  Status Clinical Trial Phase
Not yet recruiting NCT05470673 - Autogenous Demineralized Dentin Graft Combined With Injectable PRF + Metronidazole Versus Autogenous Demineralized Dentin Graft Alone for Alveolar Ridge Preservation N/A
Recruiting NCT02580721 - The Influence of Mucosal Tissue Thickness on Soft and Hard Tissue Changes Around Implants N/A
Completed NCT02515058 - Ridge Preservation Following Tooth Extraction Using Two Mineralized Cancellous Bone Allografts N/A
Enrolling by invitation NCT02209311 - Effectiveness and Safety of Method of Maxilla Alveolar Process Reconstruction Using Synthetic Tricalcium Phosphate and Autologous MMSCs Phase 1/Phase 2
Completed NCT02602223 - Comparison of Amnion Chorion Membrane vs. Dense Polytetrafluoroethylene Membrane in Ridge Preservation Procedures Phase 2
Completed NCT02255149 - A Feasibility Study for Growth Bone Vertically With Titanium Mesh and Allograft in Lower Posterior Jaw N/A
Recruiting NCT05674331 - Clinical, Radiographical, Histological Evaluation and Blood Flow Analysis of Alveolar Ridge Preservation N/A
Recruiting NCT06081296 - Dimensional Changes in Alveolar Ridge Preservation N/A
Completed NCT03944811 - Bone Height Gain Following Transcrestal Sinus Floor Elevation Using Piezoelectric Surgery Versus The Conventional Osteotome Technique N/A
Completed NCT03045458 - Associations of Alveolar Bone Loss and Interleukin-1β Levels in One and Two Stage Surgical Procedures N/A
Completed NCT05595746 - Radiological Bone Loss on Different Levels of Dental Implants N/A
Completed NCT03357705 - Effectiveness in Limiting the Need to Elevate the Maxillary Sinus N/A
Recruiting NCT05311735 - Mineralized and Partial Demineralized Dentin Graft Compared to FDBA N/A
Completed NCT05494476 - Stability of the Marginal Bone Around Subcrestal Implants N/A
Not yet recruiting NCT05536479 - Evaluation of Autogenous Stored Versus Autogenous Fresh Mineralized Dentin Graft for Alveolar Ridge Preservation N/A
Active, not recruiting NCT02275767 - Histological Evaluation of Healing Following Ridge Preservation Using a Combined Cortical/Cancellous Mineralized Freeze-Dried Bone Allograft N/A
Completed NCT01728844 - GUIDOR® Growth Factor Enhanced Bone Graft Substitute for the Treatment of Periodontal Defects 6-months Post-Surgery N/A
Terminated NCT00991432 - Localized Alveolar Ridge Augmentation With Space Maintenance Devices N/A
Terminated NCT00991965 - Localized Alveolar Ridge Augmentation With Dental Implant N/A
Completed NCT03149172 - Comparison of Post Tooth Extraction Healing Using Different Xenograft Materials N/A