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Completed

NCT Number: NCT07144787

Four Implant Retained Mandibular Overdenture VERSUS Fixed-detachable Prosthesis.

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.

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Key information

Conditions

Oral Health Impact Profile Short Version 14 (OHIP 14)

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Basmsa

Al Mansurah, 35511, Egypt

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

implant retained complete Overdenture

Other

four implant retained complete Overdenture versus Fixed-detachable prosthesis

Fixed-detachable prosthesis

Other

four implant retained complete Overdenture versus Fixed-detachable prosthesis.

Primary outcomes

  1. 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

  1. oral health impact profile (OHIP-14) was recorded for both prostheses.

    Time frame: 6 months

    Regarding 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.

Sponsors and collaborators

Lead sponsor

Mansoura University

Other

Registry information

Official study title

Patient Satisfaction and Oral Health Related Quality of Life for Four Implant Retained Mandibular Overdenture VERSUS Fixed-detachable Prosthesis. Crossover Clinical Study

Important dates

Study start
2024
Primary completion
2024
Study completion
2025
First posted
Aug 28, 2025
Registry last updated
Dec 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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