Edentulous
Conditions
Brief summary
The purpose of this study is to investigate to what extent IOs improve the functionality of edentulous patients and changes in quality of life and overall patient satisfaction following treatment with IOs.
Detailed description
Edentulous individuals will be selected from patients attending the prosthodontic clinic. Then, new complete dentures will be provided; in a second stage half of these subjects (randomly selected) will receive IOs. The effect of different treatment protocols on chewing ability, patient satisfaction and OHRQoL will be investigated and assessed.
Interventions
PROCEDUREimplant-retained overdentures
subjects will receive two-implant-retained overdentures in the mandible,and they continue wearing their complete denture in the maxilla.
Sponsors
Chufan Ma
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
40 Years to 75 Years
Healthy volunteers
Yes
Inclusion criteria
1. Being edentulous in the upper and lower jaw for at least 1 year 2. Dissatisfied or cannot function with their complete lower denture 3. Age between 40 and 75 4. Suitable bone quality as assessed radiographically (CBCT) according to Zarb's classification。
Exclusion criteria
1. Physical and mental disabilities which interfere with the maintenance of implants; 2. Severe skeletal jaw discrepancies (class III) 3. Those who have already received or lost dental implants 4. Those who abuse drugs or alcohol 5. Smoking more than 10 cigarettes a day 6. Having received radiotherapy to the head and neck region for malignancies 7. Undergoing chemotherapy 8. On long-term therapy with steroids 9. immunosuppressants or biphosphonates 10. Insulin-dependent diabetic patients and uncontrolled onset diabetic patients 11. Those affected by chronic renal or liver disease 12. Systemic and local bone disorders and pathology 13. Serious cardiac and pulmonary disorders 14. Haemophilic disorders who are susceptible for increased bleeding and tendency for post-operative infections 15. Those who are at risk of developing bacterial endocarditis 16. Immune system compromised patients, including those with HIV
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| masticatory efficiency | three months after restoration of the implant-retained overdenture | masticatory efficiency will be measured with chwing-gum ,and the outcome will be analysed with the viewgum software |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Oral health related quality of life | three months after restoration of the implant-retained overdenture | Oral health related quality of life will be measured with the Oral Health Impact Profile 14(OHIP-14). |
| patients' satisfaction | three months after restoration of the implant-retained overdenture | patients' satisfaction will be assessed on visual analog scales (VAS) |
Countries
China
Contacts
Primary ContactChufan Ma
Outcome results
None listed