Mandibular Implants in Elderly Patients

NCT ID: NCT01928004

Last Updated: 2021-04-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

45 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-09-30

Study Completion Date

2019-04-30

Brief Summary

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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.

Detailed Description

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Conditions

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Edentulous Complete Denture Wearers

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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implant placement

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

Group Type EXPERIMENTAL

Implant placement

Intervention Type DEVICE

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.

denture reline

conventional reline of mandibular complete denture

Group Type ACTIVE_COMPARATOR

Conventional reline

Intervention Type PROCEDURE

conventional reline of the existing mandibular complete denture

Interventions

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Implant placement

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.

Intervention Type DEVICE

Conventional reline

conventional reline of the existing mandibular complete denture

Intervention Type PROCEDURE

Other Intervention Names

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Straumann Standard Implants® (SLA surface, 8mm length, RN, 4.1mm diameter) Locator® attachments (Zest Anchors: Escondido, CA, USA)

Eligibility Criteria

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Inclusion Criteria

* 75 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

Exclusion Criteria

* severe clinical depression
* dementia
* poorly controlled diabetes
* immunosuppression
* treatment with bisphosphonates
* condition precluding the surgical intervention for implant placement
Minimum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Geneva, Switzerland

OTHER

Sponsor Role lead

Responsible Party

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Frauke Müller

Professor and Chair

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Frauke Müller, Prof. Dr. med. dent.

Role: PRINCIPAL_INVESTIGATOR

University of Geneva

Locations

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University of Geneva

Geneva, , Switzerland

Site Status

Countries

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Switzerland

References

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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.

Reference Type RESULT
PMID: 24158342 (View on PubMed)

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.

Reference Type RESULT
PMID: 30500094 (View on PubMed)

Other Identifiers

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ITI_458_2006

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

MDGPA_02

Identifier Type: -

Identifier Source: org_study_id

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