Mandibular Single Implant Overdenture: a Prospective Clinical Trial

NCT01421849 | Withdrawn

• 1 other identifier: 2011/381
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Edentulous

Keywords

single implant denture; Elderly with an unstable mandibular denture

Outcome Measures

Primary Outcomes (8)

• Patient satisfaction after insertion of the new complete dentures.

  This will be measured by a questionnaire with 20 items.

  1 week after insertion of the new complete dentures.

• Patient satisfaction after insertion of the complete dentures.

  This will be measured by a questionnaire with 20 items.

  8 weeks after insertion of the complete dentures.

• Patient satisfaction post-surgical.

  This will be measured by a questionnaire with 20 items.

  1 week post-surgical.

• Patient satisfaction after surgical procedure, functional loading.

  This will be measured by a questionnaire with 20 items.

  6-8 weeks after surgical procedure.

• Patient satisfaction after loading the implant.

  This will be measured by a questionnaire with 20 items.

  1 week after loading the implant.

• Patient satisfaction after loading.

  This will be measured by a questionnaire with 20 items.

  1 months after loading.

• Patient satisfaction after loading.

  This will be measured by a questionnaire with 20 items.

  6 months after loading

• Patient satisfaction after loading.

  This will be measured by a questionnaire with 20 items.

  1 year after loading

Secondary Outcomes (6)

• Implant level : lost implants, loose implants, …

  From the first week post-surgical to 1 year after loading.

• Soft tissue level : Peri-implant inflammation, bleeding index, probing depth

  From the first week post-surgical to 1 year after loading.

• Denture related: soft tissue problems.

  From 1 week after insertion of the new complete dentures to 6 months after loading.

• Repair management: type (fracture, matrix replacement, patrix activation, mechanical problems of the abutment, replacement of denture, relining, adjustment without adding new material) and number.

  From 8 weeks after insertion of the complete dentures to 6 months after loading.

• Maintenance - oral hygiene: Implant abutment: plaque index according to Mombelli, presence of calculus.

  From 1 week after loading the implant to 6 months after loading.

Study Arms (1)

Elderly with an unstable mandibular denture.

EXPERIMENTAL

Procedure: Denture implantation

Interventions

Denture implantation PROCEDURE

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.

Elderly with an unstable mandibular denture.

Eligibility Criteria

• Age: 70 Years - 90 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Ghent: lead
• Southern Implants, South Africa: collaborator

Study Sites (1)

University Hospital Ghent

Ghent, 9000, Belgium

Location

Related Links

• Related Info

MeSH Terms

Conditions

Mouth, Edentulous

Condition Hierarchy (Ancestors)

Mouth Diseases; Stomatognathic Diseases; Tooth Diseases

Study Officials

• Jacques Vanobbergen, MD, PhD

  University Hospital Ghent, Belgium

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 22, 2011
• First Posted: August 23, 2011
• Study Start: August 1, 2011
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2015
• Last Updated: December 15, 2022

Record last verified: 2022-12

Locations

BE (1)