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

Not Applicable

Completed

• Conditions: Implant Complication; Peri-Implantitis; Occlusal Trauma
• Interventions: Procedure: implant

• Registration Number: NCT05960500
• Lead Sponsor: Mansoura University

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

Study Timeline

• Study Start: 2022-06-05
• Primary Completion: 2023-05-10
• Study Completion: 2023-06-15
• Study First Submitted: 2023-06-18
• Status Verified: 2023-07
• Study First Submitted QC: 2023-07-14
• Study First Posted: 2023-07-25
• Last Update Submitted: 2023-07-28
• Last Update Posted: 2023-08-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 30

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Six implants in parallel distribution	implant	patients received 6 implants in parallel distribution in anterior, premolar and molar region
Six implants according to all on six concept	implant	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.

Primary Outcome Measures

Name	Time	Method
soft tissue changes around implants	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 Outcome Measures

Name	Time	Method
occlusal stability	1 year	- 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)
implant stability	1year	- 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.

Trial Locations

Locations (1)

Mansoura university; 🇪🇬 Mansoura, Dakahlya, Egypt