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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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07144787
Enrollment
10
Registered
2025-08-28
Start date
2024-05-01
Completion date
2025-01-12
Last updated
2025-12-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Oral Health Impact Profile Short Version 14 (OHIP 14)

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.

Interventions

OTHERimplant retained complete Overdenture

four implant retained complete Overdenture versus Fixed-detachable prosthesis

OTHERFixed-detachable prosthesis

four implant retained complete Overdenture versus Fixed-detachable prosthesis.

Sponsors

Mansoura University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
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

Design outcomes

Primary

MeasureTime frameDescription
patients indicated satisfaction with their prosthesis using a visual analog scale (VAS)6 monthsparticipants 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

MeasureTime frameDescription
oral health impact profile (OHIP-14) was recorded for both prostheses.6 monthsRegarding the oral health-related quality of life (OHRQoL), oral health impact profile (OHIP-14), the questions covered seven domains: functional limitation, physical pain, physical disability, psychologic discomfort, psychologic disability, social disability, and handicap. Also, these questions will be translated into Arabic by linguistic professionals who act in collaboration with the authors to prepare the final version. The translation will be made using a forward-backward approach. The answers of the questionnaire include score 1 = never, score 2 = hardly ever, score 3 = occasionally, score 4 = fairly often, and score 5 = very often.

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026