Mandibular Implants in Elderly Patients

Implant-supported Mandibular Overdentures in Very Old Adults - a Randomized Controlled Trial

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.

Study Overview

• Status: Completed
• Conditions: Edentulous Complete Denture Wearers
• Intervention / Treatment: Device: Implant placement; Procedure: Conventional reline

• Study Type: Interventional
• Enrollment (Actual): 45
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Switzerland
  • Geneva, Switzerland, 1205
    • University of Geneva

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 75 years and older (Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: implant placement; insertion of 2 interforaminal mandibular implants and conversion of the lower complete denture to an implant-overdenture	Device: 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.; Other Names: Straumann Standard Implants® (SLA surface, 8mm length, RN, 4.1mm diameter); Locator® attachments (Zest Anchors: Escondido, CA, USA)
Active Comparator: denture reline; conventional reline of mandibular complete denture	Procedure: Conventional reline; conventional reline of the existing mandibular complete denture

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from Baseline in OHRQoL	OHIP-Edent questionnaire, 20 questions	at 3, 12, 24 adn 36 months
Change from Baseline in cognitive function	Mini-Mental State Examination, to evaluate cognitive function (Folstein et al. 1975) Trail-making test A and B Verbal fluency test	at 12, 24 and 36 months
Change from Baseline in Independence	IADL Instrumental Activities of Daily Living Scale (Lawton and Brody, 1969) MIF Measure of functional independence	at 12, 24 and 36 months
Change from Baseline in MNA	Mini-nutritional Assessement questionnaire (Guigoz 1994)	at 3, 12, 24 and 36 months
Change from Baseline in Blood markers	Albumin, Folic acid, Vitamin B12 (VitB12), Hemoglobin (Hb), C-reactive protein (CRP)	at 3, 12, 24 and 36 months
Change from Baseline in BMI	Body Mass Index kg/m2	at 12, 24 and 36 months
Change from Insertion in implant survival	inserted implants in vivo	at 3, 12, 24 and 36 months
Change from Insertion in Pocket depth	mesial and distal peri-implant probing depth	at 3, 12, 24 and 36 months
Change from Insertion in Plaque index	Plaque index on implants (Silness & Loe 1963) Denture plaque index	at 3, 12, 24 and 36 months
Change from Insertion in peri-implant bone loss	mesial and distal peri-implant bone loss, as evaluated on intraoral radiographs or OPTs	at 3, 12, 24 and 36 months
Change from Baseline in Chewing efficiency	two color mixing test with bi-colored chewing gum (Schimmel et al 2007)	at Intervention, 3, 12, 24 and 36 months
Change from Baseline in Maximum bite force	unilateral maximal bite force measured with force gauge	at Intervention, 3, 12, 24 and 36 months
Change from Baseline in Stimulated Saliva Flow Rate	whole saliva collected after chewing wax for 2 minutes on one side	at Intervention, 3, 12, 24 and 36 months
Changes from Baseline in Masseter Muscle Thickness	ultrasound measurements of the masseter muscle thickness in contracted and relaxed state	at 3, 12, 24 and 36 months

Collaborators and Investigators

• Sponsor: University of Geneva, Switzerland
• Investigators: Principal Investigator: Frauke Müller, Prof. Dr. med. dent., University of Geneva

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start: September 1, 2007
• Primary Completion (Actual): April 1, 2012
• Study Completion (Actual): April 1, 2019

Study Registration Dates

• First Submitted: August 16, 2013
• First Submitted That Met QC Criteria: August 20, 2013
• First Posted (Estimate): August 23, 2013

Study Record Updates

• Last Update Posted (Actual): April 30, 2021
• Last Update Submitted That Met QC Criteria: April 27, 2021
• Last Verified: April 1, 2021

More Information

Terms related to this study

• Keywords: complete denture; edentulous
• Additional Relevant MeSH Terms: Stomatognathic Diseases; Mouth Diseases; Tooth Diseases; Mouth, Edentulous
• Other Study ID Numbers: MDGPA_02; ITI_458_2006 (Other Grant/Funding Number: International Team of Implantology ITI)