Patient Satisfaction and Oral Health Related Quality of Life for Four Implant Retained Mandibular Overdenture VERSUS Fixed-detachable Prosthesis. Crossover Clinical Study
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Mansoura University
- Enrollment
- 10
- Locations
- 1
- Primary Endpoint
- patients indicated satisfaction with their prosthesis using a visual analog scale (VAS)
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Inclusion Criteria:
- •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
Exclusion Criteria
- •uncontrolled diabetic patients
Arms & Interventions
implant retained complete Overdenture
implant retained complete Overdenture
Intervention: implant retained complete Overdenture (Other)
Fixed-detachable prosthesis.
Fixed-detachable prosthesis.
Intervention: Fixed-detachable prosthesis (Other)
Outcomes
Primary Outcomes
patients indicated satisfaction with their prosthesis using a visual analog scale (VAS)
Time Frame: 6 months
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).
patients indicated satisfaction with their prosthesis using a visual analog scale (VAS)
Time Frame: 6 months
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).
Secondary Outcomes
- oral health impact profile (OHIP-14) was recorded for both prostheses.(6 months)
- oral health impact profile (OHIP-14) was recorded for both prostheses.(6 months)