Management of Severely Atrophied Maxillary Ridge Using Quad Zygomatic Implants

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

This clinical study will aim to compare and evaluate zygomatic implant stability, occlusal contact, and bone level changes around dental implants

Study Overview

• Status: Active, not recruiting
• Conditions: Prosthesis Durability
• Intervention / Treatment: Device: Implant supported hybrid maxillary prosthesis

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.

• Study Type: Interventional
• Enrollment (Estimated): 15
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Mansoura, Egypt, P.O.Box:35516
    • Mansoura University ,Faculty of dentistry

Participation Criteria

Eligibility Criteria

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

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: quad zygomatic hybrid maxillary prosthesis; All patients will be rehabilitated with immediate loaded hybrid prosthesis supported by 4 zygomatic implants.	Device: Implant supported hybrid maxillary prosthesis; All patients will receive immediately loaded hybrid prosthesis supported by 4 zygomatic implants.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	one year

Collaborators and Investigators

• Sponsor: Mansoura University

Study record dates

Study Major Dates

• Study Start (Actual): December 15, 2022
• Primary Completion (Actual): March 7, 2023
• Study Completion (Estimated): June 16, 2024

Study Registration Dates

• First Submitted: September 4, 2023
• First Submitted That Met QC Criteria: September 4, 2023
• First Posted (Actual): September 11, 2023

Study Record Updates

• Last Update Posted (Actual): September 11, 2023
• Last Update Submitted That Met QC Criteria: September 4, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Prosthesis Failure
• Other Study ID Numbers: M03071221

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

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