All on Six Versus Parallel Implant Distribution for Maxillary Denture Opposing Mandibular All on Four

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

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-06-05

Study Completion Date

2023-06-15

Brief Summary

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Thirty maxillary edentulous patients with previous mandibular All-on-4 screw retained prosthesis and their age ranged from 55 to 65 years were selected from the outpatient clinic, of prosthodontics Department, Faculty of Dentistry, Mansoura University from March 2022 to July2022 and 80% power was used to calculate patients sample according to the results of a previous study 1 which showed no significant difference was reported when comparing occlusal stability ,implant stability and periimplant soft tissue changes between different implants angulation of both groups. (Effect size=.70mm and α=.05). The power analysis was performed using the G\*Power program (version 3.1.5, Kiel, Germany)

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Detailed Description

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the aim of this study is to compare between All-on-Six distributed dental implants "Anterior 4 Implant Parallel and Posterior 2 Implant Distally Tilted" versus parallel distribution supporting screw retained maxillary single denture regarding soft tissue changes around implants, implant stability and occlusal stability.

The primary outcome is to study implant stability and occlusal stability. The secondary outcome is to evaluate periimplant soft tissue changes. The null hypothesis of this study will be there is no difference between the two studied groups.All patients were informed about the proposal of this study, the line of treatment, and the need for regular and frequent recalls. Their acceptance to participate in this study was confirmed and they signed the consent form of the ethical committee of the faculty of dentistry. This study gained the approval of the ethical committee of the Faculty of Dentistry, with approval number (A05080622).

all the patients were divided randomly into two equal groups as follows Group I patients received four axially placed anterior Implants(\*General system) in lateral and first premolar region and two distally tilted 30 degree posteriorly in molar region relative to the occlusal plane supporting screw retained maxillary single denture.

Group II patients received 6 implants in parallel distribution in anterior, premolar and molar region

Conditions

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Peri-Implantitis Occlusal Trauma Implant Complication

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Six implants in parallel distribution

patients received 6 implants in parallel distribution in anterior, premolar and molar region

Group Type ACTIVE_COMPARATOR

implant

Intervention Type PROCEDURE

All on six versus parallel implant distribution

Six implants according to all on six concept

patients recived four axially placed anterior Implants(\*General system) in lateral and first premolar region and two distally tilted 30 degree posteriorly in molar region relative to the occlusal plane supporting screw retained maxillary single denture.

Group Type ACTIVE_COMPARATOR

implant

Intervention Type PROCEDURE

All on six versus parallel implant distribution

Interventions

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implant

All on six versus parallel implant distribution

Intervention Type PROCEDURE

Other Intervention Names

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prothesis

Eligibility Criteria

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Inclusion Criteria

* patient with maxillary edentulous alveolar ridges.
* patient complained from insufficient retention and stability of their maxillary single denture.