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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

August 22, 2011
February 1, 2013
August 2011
December 2013   (final data collection date for primary outcome measure)
  • 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.
Same as current
Complete list of historical versions of study NCT01421849 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Mandibular Single Implant Overdenture: a Prospective Clinical Trial
Patient Satisfaction and Clinical Outcomes Following Mandibular Single-implant-retained Overdenture Treatment in Residents of Nursing Homes: a Prospective Clinical Trial

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.

Not Provided
Interventional
Not Provided
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Edentulous
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.

Experimental: Elderly with an unstable mandibular denture.
Intervention: Procedure: Denture implantation
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
50
December 2013
December 2013   (final data collection date for primary outcome measure)

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
Both
70 Years to 90 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Belgium
 
NCT01421849
2011/381
No
University Hospital, Ghent
University Hospital, Ghent
Southern Implants, South Africa
Principal Investigator: Jacques Vanobbergen, MD, PhD University Hospital Ghent, Belgium
University Hospital, Ghent
February 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP