Mandibular Single Implant Overdenture: a Prospective Clinical Trial

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Southern Implants, South Africa
Information provided by (Responsible Party):
University Hospital, Ghent
ClinicalTrials.gov Identifier:
NCT01421849
First received: August 22, 2011
Last updated: February 1, 2013
Last verified: February 2013
  Purpose

Study hypothesis: that there would be no difference in patient satisfaction among institutionalised older people before and after treatment with a mandibular single implant-retained overdenture.

In a preliminary phase, a new denture is made or the old denture is adapted to provide a well-fitting denture.

Eight weeks after insertion of the new denture a single implant is placed in the centre of the mandibula. If the level of primary stability is sufficient to enable the implant to resist micromovement, the implant is immediately loaded . If not, the implant is loaded after 6 to 12 weeks. Primary stability is assessed by the final seating torque and by the clinician's interpretation and tactile sense of primary stability. Before, during and after the treatment patient satisfaction and clinical outcomes are evaluated by a 20 item questionnaire and a clinical examination.


Condition Intervention
Edentulous
Procedure: Denture implantation

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Patient Satisfaction and Clinical Outcomes Following Mandibular Single-implant-retained Overdenture Treatment in Residents of Nursing Homes: a Prospective Clinical Trial

Resource links provided by NLM:


Further study details as provided by University Hospital, Ghent:

Primary Outcome Measures:
  • Patient satisfaction after insertion of the new complete dentures. [ Time Frame: 1 week after insertion of the new complete dentures. ] [ Designated as safety issue: No ]
    This will be measured by a questionnaire with 20 items.

  • Patient satisfaction after insertion of the complete dentures. [ Time Frame: 8 weeks after insertion of the complete dentures. ] [ Designated as safety issue: No ]
    This will be measured by a questionnaire with 20 items.

  • Patient satisfaction post-surgical. [ Time Frame: 1 week post-surgical. ] [ Designated as safety issue: No ]
    This will be measured by a questionnaire with 20 items.

  • Patient satisfaction after surgical procedure, functional loading. [ Time Frame: 6-8 weeks after surgical procedure. ] [ Designated as safety issue: No ]
    This will be measured by a questionnaire with 20 items.

  • Patient satisfaction after loading the implant. [ Time Frame: 1 week after loading the implant. ] [ Designated as safety issue: No ]
    This will be measured by a questionnaire with 20 items.

  • Patient satisfaction after loading. [ Time Frame: 1 months after loading. ] [ Designated as safety issue: No ]
    This will be measured by a questionnaire with 20 items.

  • Patient satisfaction after loading. [ Time Frame: 6 months after loading ] [ Designated as safety issue: No ]
    This will be measured by a questionnaire with 20 items.

  • Patient satisfaction after loading. [ Time Frame: 1 year after loading ] [ Designated as safety issue: No ]
    This will be measured by a questionnaire with 20 items.


Secondary Outcome Measures:
  • Implant level : lost implants, loose implants, … [ Time Frame: From the first week post-surgical to 1 year after loading. ] [ Designated as safety issue: No ]
  • Soft tissue level : Peri-implant inflammation, bleeding index, probing depth [ Time Frame: From the first week post-surgical to 1 year after loading. ] [ Designated as safety issue: No ]
  • Denture related: soft tissue problems. [ Time Frame: From 1 week after insertion of the new complete dentures to 6 months after loading. ] [ Designated as safety issue: No ]
  • Repair management: type (fracture, matrix replacement, patrix activation, mechanical problems of the abutment, replacement of denture, relining, adjustment without adding new material) and number. [ Time Frame: From 8 weeks after insertion of the complete dentures to 6 months after loading. ] [ Designated as safety issue: No ]
  • Maintenance - oral hygiene: Implant abutment: plaque index according to Mombelli, presence of calculus. [ Time Frame: From 1 week after loading the implant to 6 months after loading. ] [ Designated as safety issue: No ]
  • Maintenance - oral hygiene: Dentures using the denture plaque index by Augsburger and Elahi. [ Time Frame: From 8 weeks after insertion of the complete dentures to 6 months after loading. ] [ Designated as safety issue: No ]

Estimated Enrollment: 50
Study Start Date: August 2011
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Elderly with an unstable mandibular denture. Procedure: Denture implantation

In a preliminary phase, a new denture is made according to standardized prosthodontic protocol or the old denture is adapted to provide a well-fitting denture.

Eight weeks after insertion of the new denture an implant is placed under local anaesthetics in the centre of the mandibula.If primary stability is good, the implant is immediately loaded by the denture. If not, the implant is loaded after 6 to 12 weeks. Before, during and after the treatment patient satisfaction is evaluated by a 20 item questionnaire. Afterwards questionnaires are compared. After the insertion of the implant clinical evaluations take place at several moments.

The total duration of the study will be 12 to 18 months.


  Eligibility

Ages Eligible for Study:   70 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Edentulous residents of nursing homes treated in the mobile dental unit 'Gerodent'.
  • They have to be willing to commit to 1.5 year of participation in the study.
  • They have to be edentulous for at least one year before starting the implant procedure.

Exclusion Criteria:

  • Medical conditions contraindicating implant surgery (unregulated diabetes type II, bisphosphonates)
  • History of radiotherapy in the head and neck region
  • Insufficient bone for an implant of at least 10 mm length and 4 mm diameter
  • Previously treated with dental implants
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01421849

Locations
Belgium
University Hospital Ghent
Ghent, Belgium, 9000
Sponsors and Collaborators
University Hospital, Ghent
Southern Implants, South Africa
Investigators
Principal Investigator: Jacques Vanobbergen, MD, PhD University Hospital Ghent, Belgium
  More Information

Additional Information:
No publications provided

Responsible Party: University Hospital, Ghent
ClinicalTrials.gov Identifier: NCT01421849     History of Changes
Other Study ID Numbers: 2011/381
Study First Received: August 22, 2011
Last Updated: February 1, 2013
Health Authority: Belgium: Ethics Committee

Keywords provided by University Hospital, Ghent:
single implant denture
Elderly with an unstable mandibular denture

Additional relevant MeSH terms:
Mouth, Edentulous
Mouth Diseases
Stomatognathic Diseases
Tooth Diseases

ClinicalTrials.gov processed this record on July 23, 2014