Management of Severely Atrophied Maxillary Ridge Using Quad Zygomatic Implants

Prosthesis Durability Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT06031506
• Other study ID #: M03071221
• Status: Active, not recruiting
• Phase: N/A
• Start date: December 15, 2022
• Est. completion date: June 16, 2024

Study information

• Verified date: September 2023
• Source: Mansoura University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 15
• Est. completion date: June 16, 2024
• Est. primary completion date: March 7, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 45 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Prosthesis Durability
• Prosthesis Failure

Intervention

Device:
• Implant supported hybrid maxillary prosthesis
All patients will receive immediately loaded hybrid prosthesis supported by 4 zygomatic implants.

Locations

Country	Name	City	State
Egypt	Mansoura University ,Faculty of dentistry	Mansoura

Sponsors (1)

Lead Sponsor	Collaborator
Mansoura University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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