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11 February 2012
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| [ Print-friendly version ] |
| The effect of improved oral prostheses on the nutritional state of elderly edentulous individuals |
| ISRCTN | ISRCTN24273915 |
| ClinicalTrials.gov identifier | |
| Public title | The effect of improved oral prostheses on the nutritional state of elderly edentulous individuals |
| Scientific title | The effect of improved oral prostheses on the nutritional state of elderly edentulous individuals: a randomised controlled trial |
| Acronym | SIN II |
| Serial number at source | UCT-36052 |
| Study hypothesis |
Null Hypothesis:
That there will be no difference in nutritional status measured by serum homocysteine levels in elderly edentulous males and females wearing mandibular 2-implant overdentures and those wearing mandibular conventional dentures at six months following delivery of the prostheses. |
| Lay summary | Not provided at time of registration |
| Ethics approval | McGill University Faculty of Medicine IRB, original approval received November 15, 2002; renewed yearly; latest renewal approved 29 August 2006 (study number A08-M75-02B). |
| Study design | Randomised controlled trial |
| Countries of recruitment | Canada |
| Disease/condition/study domain | Edentulism (lack of all teeth) |
| Participants - inclusion criteria |
1. Male and female seniors aged 65 and older
2. Completely edentulous for a minimum of five years 3. Wishing to replace existing conventional dentures 4. An adequate understanding of written and spoken English or French 5. Able to understand and respond to questionnaires used in the study 6. Willing and able to accept the protocol and give informed consent |
| Participants - exclusion criteria |
1. Insufficient bone to place two implants in the anterior mandible
2. Other oral conditions that preclude immediate prosthetic treatment 3. Acute or chronic symptoms of temporomandibular disorders 4. History of radiation therapy to the orofacial region 5. Systemic or neurological disease that contraindicate implant surgery 6. Any neoplasia diagnosed less than five years previously 7. Body mass index (BMI) less than 20 or greater than 32 kg/m^2 8. Score of 20 or less on the Mini-Mental State Evaluation 9. Taking any of the following which will affect blood nutrient concentrations: 9.1. Dietary supplements 9.2. Anti-neoplastic medication 9.3. Phenytoin or corticosteroids 9.4. Insulin 10. Other conditions that jeopardise surgical treatment (e.g. alcoholism) 11. Psychological or psychiatric conditions that could influence diet and reaction to treatment |
| Anticipated start date | 01/09/2002 |
| Anticipated end date | 31/12/2006 |
| Status of trial | Completed |
| Patient information material | Not available in web format, please use the contact details below to request a patient information sheet |
| Target number of participants | 254 |
| Interventions |
Control: Complete conventional dentures
Experimental: Mandibular 2-implant overdenture with ball attachments and maxillary conventional denture |
| Primary outcome measure(s) | Serum level of homocysteine. |
| Secondary outcome measure(s) |
1. Patient satisfaction
2. Vitamin status 3. Changes in serum albumin 4. Changes in dietary habits 5. Changes in function 6. Cost effectiveness |
| Sources of funding |
1. Canadian Institutes of Health Research (CIHR) (Canada) - http://www.cihr-irsc.gc.ca (ref: UCT-36052)
2. Straumann Canada (Canada) |
| Trial website | |
| Publications |
1. 2008 etiological factor results in http://www.ncbi.nlm.nih.gov/pubmed/18434573
2. 2008 sex differences results in http://www.ncbi.nlm.nih.gov/pubmed/18394770 3. 2008 research approaches http://www.ncbi.nlm.nih.gov/pubmed/19177731 4. 2009 methodological issues in http://www.ncbi.nlm.nih.gov/pubmed/19157673 5. 2011 mandibular bone height results in http://www.ncbi.nlm.nih.gov/pubmed/20708062 6. 2012 implant overdentures and nutrition results in http://www.ncbi.nlm.nih.gov/pubmed/21951464 |
| Contact name | Prof Jocelyne Feine |
| Address |
Oral Health and Society Research Unit
Suite #101 Faculty of Dentistry McGill University 3550 University Street |
| City/town | Montreal, Quebec |
| Zip/Postcode | H3A 2A7 |
| Country | Canada |
| Tel | +1 514 398 7203 ext. 00052 |
| Fax | +1 514 398 7220 |
| jocelyne.feine@mcgill.ca | |
| Sponsor | McGill University (Canada) |
| Address |
845 Sherbrooke Street West
James Administration Bldg., Suite 429 |
| City/town | Montreal, Quebec |
| Zip/Postcode | H3A 2T5 |
| Country | Canada |
| Tel | +1 514 398 4455 |
| Fax | +1 514 398 3594 |
| jacques.hurtubise@mcgill.ca | |
| Sponsor website: | http://www.mcgill.ca/ |
| Date applied | 20/10/2004 |
| Last edited | 31/01/2012 |
| Date ISRCTN assigned | 28/07/2005 |
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