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Four Implant Retained Mandibular Overdenture VERSUS Fixed-detachable Prosthesis.

NCT ID: NCT07144787

Last Updated: 2025-12-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-05-01

Study Completion Date

2025-01-12

Brief Summary

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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.

Detailed Description

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Conditions

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Oral Health Impact Profile Short Version 14 (OHIP 14)

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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implant retained complete Overdenture

implant retained complete Overdenture

Group Type ACTIVE_COMPARATOR

implant retained complete Overdenture

Intervention Type OTHER

four implant retained complete Overdenture versus Fixed-detachable prosthesis

Fixed-detachable prosthesis.

Fixed-detachable prosthesis.

Group Type ACTIVE_COMPARATOR

Fixed-detachable prosthesis

Intervention Type OTHER

four implant retained complete Overdenture versus Fixed-detachable prosthesis.

Interventions

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implant retained complete Overdenture

four implant retained complete Overdenture versus Fixed-detachable prosthesis

Intervention Type OTHER

Fixed-detachable prosthesis

four implant retained complete Overdenture versus Fixed-detachable prosthesis.

Intervention Type OTHER

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Mansoura University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Basmsa

Al Mansurah, , Egypt

Site Status

Countries

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Egypt

Other Identifiers

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A02010024RP

Identifier Type: -

Identifier Source: org_study_id