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Clinical Trials/NCT05960500
NCT05960500
Completed
Not Applicable

All on Six Versus Parallel Implant Distribution for Screw Retained Maxillary Fixed Single Denture Opposing Mandibular All on Four Implant Distribution

Mansoura University1 site in 1 country30 target enrollmentJune 5, 2022

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Peri-Implantitis
Sponsor
Mansoura University
Enrollment
30
Locations
1
Primary Endpoint
soft tissue changes around implants
Status
Completed
Last Updated
2 years ago

Overview

Brief Summary

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)

Detailed Description

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

Registry
clinicaltrials.gov
Start Date
June 5, 2022
End Date
June 15, 2023
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Male

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Mennat Elrahman Essam Eldeen

Assistant Lecturer

Mansoura University

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

  • medically compromised patients.
  • patients with parafunctional habits.

Outcomes

Primary Outcomes

soft tissue changes around implants

Time Frame: 1 year

The distance between marginal gingiva and the tip of the probe was measured using a calibrated plastic periodontal probe this distance is considered as pocket depth (PD).Probing depth was evaluated at buccal, lingual, mesial and distal aspect of each implant. using a calibrated pressure sensitive plastic periodontal probe.

Secondary Outcomes

  • occlusal stability(1 year)
  • implant stability(1year)

Study Sites (1)

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