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

Primary Purpose

Peri-Implantitis, Occlusal Trauma, Implant Complication

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
implant
Sponsored by
Mansoura University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Peri-Implantitis focused on measuring soft tissue changes, occlusal stability, implant stability

Eligibility Criteria

55 Years - 65 Years (Adult, Older Adult)MaleAccepts Healthy Volunteers

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.

Sites / Locations

  • Mansoura university

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Six implants in parallel distribution

Six implants according to all on six concept

Arm Description

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

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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)
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.

Full Information

First Posted
June 18, 2023
Last Updated
July 28, 2023
Sponsor
Mansoura University
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1. Study Identification

Unique Protocol Identification Number
NCT05960500
Brief Title
All on Six Versus Parallel Implant Distribution for Maxillary Denture Opposing Mandibular All on Four
Acronym
ASPISRMSDOMF
Official Title
All on Six Versus Parallel Implant Distribution for Screw Retained Maxillary Fixed Single Denture Opposing Mandibular All on Four Implant Distribution
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Completed
Study Start Date
June 5, 2022 (Actual)
Primary Completion Date
May 10, 2023 (Actual)
Study Completion Date
June 15, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mansoura University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Peri-Implantitis, Occlusal Trauma, Implant Complication
Keywords
soft tissue changes, occlusal stability, implant stability

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Non-Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Six implants in parallel distribution
Arm Type
Active Comparator
Arm Description
patients received 6 implants in parallel distribution in anterior, premolar and molar region
Arm Title
Six implants according to all on six concept
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
implant
Other Intervention Name(s)
prothesis
Intervention Description
All on six versus parallel implant distribution
Primary Outcome Measure Information:
Title
soft tissue changes around implants
Description
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.
Time Frame
1 year
Secondary Outcome Measure Information:
Title
occlusal stability
Description
- 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)
Time Frame
1 year
Title
implant stability
Description
- 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.
Time Frame
1year

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
55 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mennat Elrahman Essam Eldeen, Phd
Organizational Affiliation
Mansoura university Faculty of Dentistry Prosthodontics Department
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mansoura university
City
Mansoura
State/Province
Dakahlya
ZIP/Postal Code
35511
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing 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.

Learn more about this trial

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

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