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Mandibular Single Implant Overdenture: a Prospective Clinical Trial

NCT01421849 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2022-12-15

No results posted yet for this study

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

Interventions

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.

Sponsors & Collaborators

  • Southern Implants, South Africa

    collaborator UNKNOWN

  • University Hospital, Ghent

    lead OTHER

Principal Investigators

  • Jacques Vanobbergen, MD, PhD · University Hospital Ghent, Belgium

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
70 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2011-08-31
Primary Completion
2015-12-31
Completion
2015-12-31

Countries

  • Belgium

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01421849 on ClinicalTrials.gov