Patient Satisfaction Using Implant Retained Overdentures Clinical Trial
Official title:
A Seven-year Follow-up Study of Patient Satisfaction With Three-Implant-Retained Mandibular Overdentures
| NCT number | NCT04726540 |
| Other study ID # | 1224 |
| Secondary ID | |
| Status | Completed |
| Phase | |
| First received | |
| Last updated | |
| Start date | January 12, 2013 |
| Est. completion date | January 25, 2020 |
| Verified date | January 2021 |
| Source | October University for Modern Sciences and Arts |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational [Patient Registry] |
Purpose: This study aimed to compare patients' satisfaction with mandibular overdentures retained by three-splinted implants and conventional complete dentures during a seven-year follow-up period. Materials and Methods: Thirty edentulous male patients (mean age: 60 years) were carefully selected and divided into two equal groups. All patients received a new set of complete dentures. (Group I) patients received three implants in the anterior mandible and were connected after three months with bars, clips and loaded. (Group II) patients' received conventional complete dentures. Patients' satisfaction was recorded for both groups at three weeks (baseline) and after 1, 3, 5 and 7 years. Patients were then asked to grade their overdentures/dentures on a visual analog scale and written questionnaire to evaluate their overall satisfaction. Results: satisfaction scores of Group I patients was found to be statistically significantly higher than that of Group II patients (p < .05) at 3, 5 and 7 years follow-up, meanwhile no statistically significant difference was found at baseline or after 12 months. Conclusions: The long-term results suggest that three implants-retained mandibular overdenture with a clip-bar attachment appears to be a successful rehabilitation strategy which is superior to conventional dentures for patients with advanced ridge resorption.
| Status | Completed |
| Enrollment | 30 |
| Est. completion date | January 25, 2020 |
| Est. primary completion date | January 15, 2019 |
| Accepts healthy volunteers | |
| Gender | Male |
| Age group | 58 Years to 62 Years |
| Eligibility | Inclusion Criteria: - The inclusion criteria stipulated that patients must have been wearing dentures on a regular basis, have been edentulous for a minimum of 3-years, and are capable of reading and writing. Exclusion Criteria: - insufficient bone volume to install three 13mm. interforaminal implants (Group I), insufficient interarch space. Patients with diabetes, osteoporosis, smokers, psychological problems of removable denture acceptance, gag reflex, absence of a maxillary complete denture and medical or physical considerations that would seriously affect the surgical procedure (Group I) or the follow-up period were also excluded |
| Country | Name | City | State |
|---|---|---|---|
| n/a | |||
| Lead Sponsor | Collaborator |
|---|---|
| October University for Modern Sciences and Arts |
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Patient Satisfaction | Patients were then asked to grade their overdentures/dentures on a visual analog scale and written questionnaire to evaluate their overall satisfaction. | Seven years |