NCT01928004

Brief Summary

The purpose of this study is to investigate denture satisfaction following the conversion of existing mandibular complete dentures to implant-overdentures (IOD) in very old edentulous patients who depend on help for activities of daily living (ADL) and evaluate secondary endpoints such as functional, structural, nutritional, cognitive and patient-centered outcome measures.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
45

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2007

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2007

Completed
4.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2012

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

August 16, 2013

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 23, 2013

Completed
5.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2019

Completed
Last Updated

April 30, 2021

Status Verified

April 1, 2021

Enrollment Period

4.6 years

First QC Date

August 16, 2013

Last Update Submit

April 27, 2021

Conditions

Edentulous Complete Denture Wearers

Keywords

edentulouscomplete denture

Outcome Measures

Primary Outcomes (1)

  • Change from Baseline in Denture satisfaction

    VAS-scale score to evaluate the subjective satisfaction with the denture

    at 3, 12, 24 and 36 months

Secondary Outcomes (14)

  • Change from Baseline in OHRQoL

    at 3, 12, 24 adn 36 months

  • Change from Baseline in cognitive function

    at 12, 24 and 36 months

  • Change from Baseline in Independence

    at 12, 24 and 36 months

  • Change from Baseline in MNA

    at 3, 12, 24 and 36 months

  • Change from Baseline in Blood markers

    at 3, 12, 24 and 36 months

  • +9 more secondary outcomes

Study Arms (2)

implant placement

EXPERIMENTAL

insertion of 2 interforaminal mandibular implants and conversion of the lower complete denture to an implant-overdenture

Device: Implant placement

denture reline

ACTIVE COMPARATOR

conventional reline of mandibular complete denture

Procedure: Conventional reline

Interventions

Implant placementDEVICE

Participants received two Straumann Standard Implants® in the interforaminal region using the recommended surgical protocol. The implants were loaded using Locator® attachments after six to eight weeks healing time by transforming the existing lower denture to an IOD.

Also known as: Straumann Standard Implants® (SLA surface, 8mm length, RN, 4.1mm diameter), Locator® attachments (Zest Anchors: Escondido, CA, USA)
implant placement
Conventional relinePROCEDURE

conventional reline of the existing mandibular complete denture

denture reline

Eligibility Criteria

Age75 Years+
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)

You may qualify if:

  • years or older
  • living institutionalized or receiving help for the ADL
  • edentulous
  • wearing complete dentures
  • the lower denture had to cause discomfort to the degree that the patients were seeking treatment

You may not qualify if:

  • severe clinical depression
  • dementia
  • poorly controlled diabetes
  • immunosuppression
  • treatment with bisphosphonates
  • condition precluding the surgical intervention for implant placement

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Geneva

Geneva, 1205, Switzerland

Location

Related Publications (2)

  • Muller F, Duvernay E, Loup A, Vazquez L, Herrmann FR, Schimmel M. Implant-supported mandibular overdentures in very old adults: a randomized controlled trial. J Dent Res. 2013 Dec;92(12 Suppl):154S-60S. doi: 10.1177/0022034513509630. Epub 2013 Oct 24.

    PMID: 24158342RESULT

  • Maniewicz S, Duvernay E, Srinivasan M, Perneger T, Schimmel M, Muller F. Effect of implant-supported mandibular overdentures versus reline on masticatory performance and salivary flow rates in very old adults-A randomized clinical trial. Clin Oral Implants Res. 2019 Jan;30(1):59-67. doi: 10.1111/clr.13392. Epub 2018 Dec 30.

    PMID: 30500094RESULT

MeSH Terms

Conditions

Mouth, Edentulous

Condition Hierarchy (Ancestors)

Mouth DiseasesStomatognathic DiseasesTooth Diseases

Study Officials

  • Frauke Müller, Prof. Dr. med. dent.

    University of Geneva

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor and Chair

Study Record Dates

First Submitted

August 16, 2013

First Posted

August 23, 2013

Study Start

September 1, 2007

Primary Completion

April 1, 2012

Study Completion

April 1, 2019

Last Updated

April 30, 2021

Record last verified: 2021-04

Locations

CH(1)