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

NCT05960500 | Completed

• 1 other identifier: A05080622
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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)

Conditions

Peri-Implantitis; Occlusal Trauma; Implant Complication

Keywords

soft tissue changes; occlusal stability; implant stability

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• occlusal stability

  1 year

• implant stability

  1year

Study Arms (2)

Six implants in parallel distribution

ACTIVE COMPARATOR

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

Procedure: implant

Six implants according to all on six concept

ACTIVE COMPARATOR

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

Interventions

implant PROCEDURE

All on six versus parallel implant distribution

Also known as: prothesis

Six implants according to all on six concept; Six implants in parallel distribution

Eligibility Criteria

• Age: 55 Years - 65 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• medically compromised patients.
• patients with parafunctional habits.

Sponsors & Collaborators

• Mansoura University: lead

Study Sites (1)

Mansoura university

Al Mansurah, Dakahlya, 35511, Egypt

Location

MeSH Terms

Conditions

Peri-Implantitis

Interventions

Drug Implants

Condition Hierarchy (Ancestors)

Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Delayed-Action Preparations; Dosage Forms; Pharmaceutical Preparations

Study Officials

• Mennat Elrahman Essam Eldeen, Phd

  Mansoura university Faculty of Dentistry Prosthodontics Department

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Lecturer

Study Record Dates

• First Submitted: June 18, 2023
• First Posted: July 25, 2023
• Study Start: June 5, 2022
• Primary Completion: May 10, 2023
• Study Completion: June 15, 2023
• Last Updated: August 1, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)