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The effect of improved oral prostheses on the nutritional state of elderly edentulous individuals

The effect of improved oral prostheses on the nutritional state of elderly edentulous individuals: a randomised controlled trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN24273915
Enrollment
254
Registered
2005-07-28
Start date
2002-09-01
Completion date
Unknown
Last updated
2015-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Edentulism (lack of all teeth) Oral Health Edentulism

Interventions

Control: Complete conventional dentures Experimental: Mandibular 2-implant overdenture with ball attachments and maxillary conventional denture

Sponsors

McGill University (Canada)
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frame
Serum level of homocysteine.

Secondary

MeasureTime frame
1. Patient satisfaction 2. Vitamin status 3. Changes in serum albumin 4. Changes in dietary habits 5. Changes in function 6. Cost effectiveness

Countries

Canada

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026