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.

Study Overview

• Status: Withdrawn
• Conditions: Edentulous
• Intervention / Treatment: Procedure: Denture implantation

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Belgium
  • Ghent, Belgium, 9000
    • University Hospital Ghent

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 70 years to 90 years (Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Time Frame
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.
Maintenance - oral hygiene: Dentures using the denture plaque index by Augsburger and Elahi.	From 8 weeks after insertion of the complete dentures to 6 months after loading.

Collaborators and Investigators

• Sponsor: University Hospital, Ghent
• Collaborators: Southern Implants, South Africa
• Investigators: Principal Investigator: Jacques Vanobbergen, MD, PhD, University Hospital Ghent, Belgium

Publications and helpful links

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start: August 1, 2011
• Primary Completion (Anticipated): December 1, 2015
• Study Completion (Anticipated): December 1, 2015

Study Registration Dates

• First Submitted: August 22, 2011
• First Submitted That Met QC Criteria: August 22, 2011
• First Posted (Estimate): August 23, 2011

Study Record Updates

• Last Update Posted (Estimate): December 15, 2022
• Last Update Submitted That Met QC Criteria: December 13, 2022
• Last Verified: December 1, 2022

More Information

Terms related to this study

• Keywords: single implant denture; Elderly with an unstable mandibular denture
• Additional Relevant MeSH Terms: Stomatognathic Diseases; Mouth Diseases; Tooth Diseases; Mouth, Edentulous
• Other Study ID Numbers: 2011/381