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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05960500
Other study ID # A05080622
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date June 5, 2022
Est. completion date June 15, 2023

Study information

Verified date July 2023
Source Mansoura University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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)


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


Recruitment information / eligibility

Status Completed
Enrollment 30
Est. completion date June 15, 2023
Est. primary completion date May 10, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Male
Age group 55 Years to 65 Years
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
implant
All on six versus parallel implant distribution

Locations

Country Name City State
Egypt Mansoura university Mansoura Dakahlya

Sponsors (1)

Lead Sponsor Collaborator
Mansoura University

Country where clinical trial is conducted

Egypt, 

Outcome

Type Measure Description Time frame Safety issue
Primary soft tissue changes around implants 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. 1 year
Secondary occlusal stability - Evaluation of the the concentration, changes of occlusion and visualization of the masticatory pressure conditions and amount of occlusal wear occured by Digital Occlusal Analyzer System (OccluSense) 1 year
Secondary implant stability - Evaluation of the rate of Implant stability A range of PTVs (- 6 to +2) was considered for integrated implants that was measured by periotest device*. The hand piece was. held perpendicular to the long axis of the implants. 1year
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