Evaluation of the All-on-three Concept in Mandible.

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

2022-03-19

Study Completion Date

2025-02-09

Brief Summary

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Evaluation of the clinical and radiographic treatment outcomes of immediately loaded three implants by fixed-detachable prostheses for the management of totally edentulous mandibles.

The hypothesis is that mandibular immediately loaded fixed detachable restorations supported only by three implants in the inter-foraminal region will not adversely affect the clinical or radiographical treatment outcome.

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Detailed Description

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The ideal amount of implants for edentulous mandible rehabilitation continues to be a subject of scholarly debate. Traditionally, at least four implants are required for fixed detachable prostheses, but increasing implant numbers raises costs and complexity, leading to patient reluctance. Reducing the number to three implants may simplify surgery, minimize trauma, and encourage patient acceptance.

Conditions

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Dental Prosthesis Dental Implant

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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completely edentulous patients

fixed detachable restorations on three dental implants in the mandible

Group Type EXPERIMENTAL

three dental implants

Intervention Type PROCEDURE

fixed detachable prosthesis

Interventions

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three dental implants

fixed detachable prosthesis

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Completely edentulous patients with skeletal Class I maxilla-mandibular relationship.
* Adequate inter-arch space (22 mm), measured using the "try in" before any intervention.
* Male or female patients aged between 40 and 60 years.
* Maxillary and mandibular ridges with no history of recent extraction.
* Mandibular ridge should be ≥15 mm in height and ≥7 mm in width to accommodate three implants in the intra-foramina area of the mandibular arch, verified by using cone beam computed tomography (CBCT).

Exclusion Criteria

* History of radiotherapy in the head and neck region.
* History of hard tissue augmentation.
* Presence of any intra-oral pathological condition.
* Any medical disorder that could complicate the surgical phase or affect osseointegration, such as osteoporosis, uncontrolled diabetes, and hypertension.
* Smoker and bruxer patients.

Minimum Eligible Age

40 Years

Maximum Eligible Age

60 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes