Oral rehabilitation coupled with dietary intervention for older patients

Not Applicable

Completed

• Conditions: utrition; Nutritional, Metabolic, Endocrine

• Registration Number: ISRCTN66118345
• Lead Sponsor: Queen's University Belfast (UK)

Brief Summary

2020 Other publications in https://pubmed.ncbi.nlm.nih.gov/32855815/ feasibility paper (added 02/09/2020) 2023 Results article in https://pubmed.ncbi.nlm.nih.gov/36771437/ (added 19/05/2023)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-04-25
• Study Completion: 2019-07-23
• Last Update Posted: 29 May 2023

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 54

Inclusion Criteria

Current inclusion criteria as of 18/03/2020::
1. A minimum of six natural teeth in at least one jaw with missing natural teeth replaced with removable partial dentures or fixed prosthodontics
2. Patients over the age of 65 years
3. No medical complications which contraindicate routine dental treatment (e.g., unstable cngina; INR level> 4; high risk of infective endocarditis)
4. No evidence of dementia
5. Able to communicate in English
6. Sufficient level of literacy to read study materials and keep a food diary
7. No evidence of diabetes mellitus (Type 1, or Type 2)
8. No history of alcoholism
9. Free-living participant
10. No active treatment for psychiatric disorders
11. Did not follow a strict diet regime recommended by a physician in the prevention or treatment of disease

Previous inclusion criteria:
1. A minimum of six natural teeth in at least one jaw with missing natural teeth replaced with removable partial dentures or fixed prosthodontics
2. Patients over the age of 65 years
3. No medical complications which contraindicate routine dental treatment (e.g., unstable Angina; INR level> 4; high risk of Infective Endocarditis)
4. No evidence of Dementia
5. Able to communicate in English
6. Sufficient level of literacy to read study materials and keep a food diary

Exclusion Criteria

Current exclusion criteria as of 18/03/2020::
1. Less than six natural teeth in at least one jaw
2. Patients under the age of 65 years
3. Medical complications which contraindicate routine dental treatment (e.g., unstable Angina; INR level> 4; high risk of infective endocarditis)
4. Evidence of dementia
5. Inability to communicate in English
6. Insufficient level of literacy to read study materials and keep a food diary
7. Evidence of diabetes mellitus (Type 1, or Type 2)
8. History of alcoholism
9. Not a free-living participant
10. Active treatment for psychiatric disorders
11. Followed a strict diet regime recommended by a physician in the prevention or treatment of disease

Previous exclusion criteria:
1. Less than six natural teeth in at least one jaw
2. Patients under the age of 65 years
3. Medical complications which contraindicate routine dental treatment (e.g., unstable Angina; INR level> 4; high risk of Infective Endocarditis)
4. Evidence of Dementia
5. Inability to communicate in English
6. Insufficient level of literacy to read study materials and keep a food diary

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Self-reported automaticity for healthy food choices (habit-formation indicator) measured using 4-item Self-Report Habit Index (SRHI) on a scale of 1-7

Secondary Outcome Measures

Name	Time	Method
1. Consumption of fruit and vegetables, wholegrains and proteins using validated food diaries<br>2. Food-related well-being using the validated self-report satisfaction with food-related life scale<br>3. Knowledge of diet-disease relationships and food preparation abilities (from validated General nutrition knowledge questionnaire [Parmenter & Wardle, 1999]; cooking and food abilities [McGowan et al. in press])<br>4. Oral health-related Quality of Life using the validated short -form Oral Health Impact profile<br>5. Markers of nutritional status including haematological analysis of carotenoids, vitamin C, alkylresorcinols and iron, vitamin B12 and folate and the Mini Nutritional Assessment (MNA)