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| ID | Type | Description | Link |
|---|---|---|---|
| ITI_458_2006 | Other Grant/Funding Number | International Team of Implantology ITI |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| implant placement | Experimental | insertion of 2 interforaminal mandibular implants and conversion of the lower complete denture to an implant-overdenture |
|
| denture reline | Active Comparator | conventional reline of mandibular complete denture |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Implant placement | 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. |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Frauke Müller, Prof. Dr. med. dent. | University of Geneva, Switzerland | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Geneva | Geneva | 1205 | Switzerland |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24158342 | Result | 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. | |
| 30500094 | Result | 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. |
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| ID | Term |
|---|---|
| D009066 | Mouth, Edentulous |
| ID | Term |
|---|---|
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
| D014076 | Tooth Diseases |
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| Conventional reline | Procedure | conventional reline of the existing mandibular complete denture |
|
| 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 |