Loss of teeth Oral Health
Conditions
Interventions
Patients will receive treatment based upon random assignment to one of the treatment arms in the study.
1. Functionally orientated treatment (SDA group)
Following an initial clinical examination by
Sponsors
Health Research Board (Ireland)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: In this study, the target population is older partially dentate patients living in Cork city and the surrounding areas in the southwest of Ireland. 1. Partially dentate patients aged 65 years and older 2. Who request treatment to replace missing teeth 3. A minimum of six sound natural teeth in at least one jaw which are suitable for fixed bridges 4.. No medical complications which contraindicate routine dental treatment (e.g., unstable angina; INR level > 4; high risk of infective endocarditis) 5. No evidence of dementia 6. Able to have dental treatment in a dental chair 7. Able to communicate in English
Exclusion criteria
Exclusion criteria: 1. Less than six sound natural teeth remaining in at least one jaw 2. Medical complications which precluded routine dental care 3. Evidence of dementia 4. Inability to receive dental treatment in a dental chair 5. Inability to communicate in English 6. Unwilling to accept randomised treatment allocation 7. Unwilling to participate with questionnaires 8. Unwilling/unable to provide a haematological sample 9. Unwilling/unable to provide anthropometry measurements for Mini Nutritional Assessment (MNA) 10. Unwilling to attend for follow-up appointments post treatment
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Oral Health related Quality of Life (OHrQOL) is the primary outcome measure in this study. OHrQoL will be measured using the OHIP-14 questionnaire. The questionnaire will be administered by a research nurse at baseline, 6 months, 12 months and 24 months after treatment intervention. The research nurse will read the questionnaire aloud to each of the patients and complete their responses in an answer booklet. Patients record their opinions on 14 statements related to their mouth, teeth or dentures using the OHIP-14 questionnaire. The reference period used in all cases will 1 month i.e. all of the questions asked began with the stem ?during the last month?. Each statement is accompanied with a Likert-type scale which generated a score ranging from 0 to 4 (0 = never; 1 = hardly ever; 2 = occasionally; 3 = fairly often; 4 = very often). These individual scores will be added together to give a summary score ranging from 0 (minimum) to 56 (maximum). As the questionnaire only records negative events, high scores indicate poor OHrQoL with low scores indicating better OHrQoL. The research nurse administering the questionnaires will be blinded to the treatment group allocation of all participants. | — |
Secondary
| Measure | Time frame |
|---|---|
| Nutritional status will be assessed using the full version of the Mini Nutritional Assessment (MNA), which includes a measurement of Body Mass Index (BMI). This measure also includes subjective assessment and dietetic components and has been widely used as an outcome measure in studies of older adults. The MNA involves subjective assessment of appetite, mobility, dietary behaviours in addition to anthropometric data. Using the MNA scoring system, a patient who scored 17 points or less from a possible 30 is considered malnourished. A score of 17-23.5 points indicates that the patient is at risk of malnutrition. The MNA will be administered at baseline, 6 months, 12 months and 24 months after treatment intervention by a research nurse. The research nurse administering the MNA will be blinded to the treatment group allocation of all participants. In addition, each patient will provide haematological samples which will be screened for biochemical markers of nutritional status. Each sample will be tested in Cork University Hospital for: 1. C reactive protein 2. Serum albumin 3. Serum cholesterol 4. Total lymphocyte count 5. Ferritin 6. Folate 7. Vitamin B12 8. Vitamin D For each biochemical marker, levels will be compared to ?normal ranges? to indicate the nutritional status for each patient. Haematological samples will be collected from each patient at baseline (pre treatment), 6 months, 12 months and 24 months after the treatment intervention by a research nurse trained in phlebotomy. The research nurse who collected the haematological samples will be blinded to the treatment group allocation of all participants. | — |
Countries
Ireland
Outcome results
None listed