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

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

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)

Study Overview

• Status: Completed
• Conditions: Peri-Implantitis; Implant Complication; Occlusal Trauma
• Intervention / Treatment: Procedure: implant

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 Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Dakahlya
    • Mansoura, Dakahlya, Egypt, 35511
      • Mansoura University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Six implants in parallel distribution; patients received 6 implants in parallel distribution in anterior, premolar and molar region	Procedure: implant; All on six versus parallel implant distribution; Other Names: prothesis
Active Comparator: 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.	Procedure: implant; All on six versus parallel implant distribution; Other Names: prothesis

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: Mansoura University
• Investigators: Principal Investigator: Mennat Elrahman Essam Eldeen, Phd, Mansoura university Faculty of Dentistry Prosthodontics Department

Study record dates

Study Major Dates

• Study Start (Actual): June 5, 2022
• Primary Completion (Actual): May 10, 2023
• Study Completion (Actual): June 15, 2023

Study Registration Dates

• First Submitted: June 18, 2023
• First Submitted That Met QC Criteria: July 14, 2023
• First Posted (Actual): July 25, 2023

Study Record Updates

• Last Update Posted (Actual): August 1, 2023
• Last Update Submitted That Met QC Criteria: July 28, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Keywords: implant stability; soft tissue changes; occlusal stability
• Additional Relevant MeSH Terms: Stomatognathic Diseases; Periodontal Diseases; Mouth Diseases; Peri-Implantitis
• Other Study ID Numbers: A05080622

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: . Evaluation was done for all patients at three evaluation periods as follows: T0: immediately before screwing the final prosthesis.T6: 6 months after unscrewing of the final prosthesis.T12: 12 months after unscrewing of the final prosthesis.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No