Four Implant Retained Mandibular Overdenture VERSUS Fixed-detachable Prosthesis.
Patient Satisfaction and Oral Health Related Quality of Life for Four Implant Retained Mandibular Overdenture VERSUS Fixed-detachable Prosthesis. Crossover Clinical Study
1 other identifier
interventional
10
1 country
1
Brief Summary
ABSTRACT Statement of the problem: completely edentulous patient can be treated by four implants for implant retained overdenture or fixed detachable prosthesis. Purpose: the purpose of this clinical study is to evaluate patient satisfaction and oral health impact profile (OHIP-14) for four implant retained complete Overdenture versus Fixed-detachable prosthesis. Material and methods: This clinical cross-over study included 10 completely edentulous patients with maxillary single denture and four parallel implants were placed intraforminal. Every patient received two mandibular implants at the 1st premolar region and two mandibular implants in lateral incisor region. Ten completely edentulous patients received implant retained overdenture for six months (Group I), then fixed detachable prostheses on four implants for the following six months (Group II). For both designs, patient satisfaction using visual analogue scale (VAS) and oral health impact profile (OHIP-14) will be recorded for both prostheses. SPSS program will be used for statistical analysis.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started May 2024
Shorter than P25 for not_applicable
1 active site
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
May 1, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
January 12, 2025
CompletedFirst Submitted
Initial submission to the registry
August 25, 2025
CompletedFirst Posted
Study publicly available on registry
August 28, 2025
CompletedDecember 24, 2025
August 1, 2025
3 months
August 25, 2025
December 17, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
patients indicated satisfaction with their prosthesis using a visual analog scale (VAS)
participants will be asked to score their answer according to the amount of satisfaction on a 100 mm line (Score 0 = no satisfaction at all and score 100 = complete satisfaction).
6 months
Secondary Outcomes (1)
oral health impact profile (OHIP-14) was recorded for both prostheses.
6 months
Study Arms (2)
implant retained complete Overdenture
ACTIVE COMPARATORimplant retained complete Overdenture
Fixed-detachable prosthesis.
ACTIVE COMPARATORFixed-detachable prosthesis.
Interventions
four implant retained complete Overdenture versus Fixed-detachable prosthesis
four implant retained complete Overdenture versus Fixed-detachable prosthesis.
Eligibility Criteria
You may qualify if:
- This research will be done on patients who were previously received 2 mesially placed implants in the 1st premolar region with only two remaining mandibular canines with opposing maxillary single denture
You may not qualify if:
- uncontrolled diabetic patients
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Basmsa
Al Mansurah, 35511, Egypt
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 25, 2025
First Posted
August 28, 2025
Study Start
May 1, 2024
Primary Completion
August 1, 2024
Study Completion
January 12, 2025
Last Updated
December 24, 2025
Record last verified: 2025-08