A Seven-year Follow-up Study of Patient Satisfaction With Three-Implant-Retained Mandibular Overdentures
1 other identifier
observational
30
0 countries
N/A
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Jan 2013
Longer than P75 for all trials
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 12, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 15, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
January 25, 2020
CompletedFirst Submitted
Initial submission to the registry
January 22, 2021
CompletedFirst Posted
Study publicly available on registry
January 27, 2021
CompletedJanuary 27, 2021
January 1, 2021
6 years
January 22, 2021
January 22, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Study Arms (2)
Group I
Group II
Interventions
Patients were then asked to grade their overdentures/dentures on a visual analog scale and written questionnaire to evaluate their overall satisfaction.
Eligibility Criteria
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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- OTHER
- Time Perspective
- OTHER
- Target Duration
- 7 Years
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Ass. Prof. Prosthodontics
Study Record Dates
First Submitted
January 22, 2021
First Posted
January 27, 2021
Study Start
January 12, 2013
Primary Completion
January 15, 2019
Study Completion
January 25, 2020
Last Updated
January 27, 2021
Record last verified: 2021-01
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, CSR