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Management of Severely Atrophied Maxillary Ridge Using Quad Zygomatic Implants

Primary Purpose

Prosthesis Durability

Status
Active
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Implant supported hybrid maxillary prosthesis
Sponsored by
Mansoura University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Prosthesis Durability

Eligibility Criteria

45 Years - 70 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: All patients will have healthy healed residual alveolar ridges, Angle's class I maxillomandibular relations, available maxillary restorative space. This will be verified by tentative jaw relation records. Exclusion Criteria: All detrimental bad habits like smoking, TMJ clicking or TMJ dysfunction will be excluded.

Sites / Locations

  • Mansoura University ,Faculty of dentistry

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

quad zygomatic hybrid maxillary prosthesis

Arm Description

All patients will be rehabilitated with immediate loaded hybrid prosthesis supported by 4 zygomatic implants.

Outcomes

Primary Outcome Measures

patient satisfaction
The patient satisfaction will be evaluated using the visual analog scale (VAS) questionnaire at base line, 6, and 12 months later
marginal implant bone loss
The implant marginal bone height changes will be measured radiographically at base line, 6, and 12 months later

Secondary Outcome Measures

posterior area index
the area index of the anterior and posterior maxillary ridge will be measured radiographically at base line, 6, and 12 months later

Full Information

First Posted
September 4, 2023
Last Updated
September 4, 2023
Sponsor
Mansoura University
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1. Study Identification

Unique Protocol Identification Number
NCT06031506
Brief Title
Management of Severely Atrophied Maxillary Ridge Using Quad Zygomatic Implants
Official Title
Management of Severely Atrophied Maxillary Ridge Using Quad Zygomatic Implants to Support Immediately Loaded Hybrid Prosthesis.One Year Evaluation of Occlusal Contact and Ridge Resorption
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
December 15, 2022 (Actual)
Primary Completion Date
March 7, 2023 (Actual)
Study Completion Date
June 16, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
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
This clinical study will aim to compare and evaluate zygomatic implant stability, occlusal contact, and bone level changes around dental implants
Detailed Description
The aim of this study will be to compare and evaluate zygomatic implant stability, occlusal contact, and bone level changes around dental implants and that of the atrophied maxilla rehabilitated with immediate loaded hyprid prosthesis supported by 4 zygomatic implants.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prosthesis Durability

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
All patients will receive conventional maxillary and mandibular complete dentures The implant size will be selected for each area according to the available bone length and width as measured by CBCT radiograph. All implants will be surgically installed guided by steriolethognathic stents - Multi-unit abutments will be connected to implants and will be immedietly loaded by fixed full arch screw retained provisional acrylic restoration. Final prosthesis will be delivered 6-8 months later
Masking
None (Open Label)
Allocation
N/A
Enrollment
15 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
quad zygomatic hybrid maxillary prosthesis
Arm Type
Experimental
Arm Description
All patients will be rehabilitated with immediate loaded hybrid prosthesis supported by 4 zygomatic implants.
Intervention Type
Device
Intervention Name(s)
Implant supported hybrid maxillary prosthesis
Intervention Description
All patients will receive immediately loaded hybrid prosthesis supported by 4 zygomatic implants.
Primary Outcome Measure Information:
Title
patient satisfaction
Description
The patient satisfaction will be evaluated using the visual analog scale (VAS) questionnaire at base line, 6, and 12 months later
Time Frame
one year
Title
marginal implant bone loss
Description
The implant marginal bone height changes will be measured radiographically at base line, 6, and 12 months later
Time Frame
one year
Secondary Outcome Measure Information:
Title
posterior area index
Description
the area index of the anterior and posterior maxillary ridge will be measured radiographically at base line, 6, and 12 months later
Time Frame
one year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: All patients will have healthy healed residual alveolar ridges, Angle's class I maxillomandibular relations, available maxillary restorative space. This will be verified by tentative jaw relation records. Exclusion Criteria: All detrimental bad habits like smoking, TMJ clicking or TMJ dysfunction will be excluded.
Facility Information:
Facility Name
Mansoura University ,Faculty of dentistry
City
Mansoura
ZIP/Postal Code
P.O.Box:35516
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Management of Severely Atrophied Maxillary Ridge Using Quad Zygomatic Implants

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