Management of Severely Atrophied Maxillary Ridge Using Quad Zygomatic Implants

NCT06031506 | Unknown

• 1 other identifier: M03071221
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Prosthesis Durability

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• posterior area index

  one year

Study Arms (1)

quad zygomatic hybrid maxillary prosthesis

EXPERIMENTAL

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

Device: Implant supported hybrid maxillary prosthesis

Interventions

Implant supported hybrid maxillary prosthesis DEVICE

All patients will receive immediately loaded hybrid prosthesis supported by 4 zygomatic implants.

quad zygomatic hybrid maxillary prosthesis

Eligibility Criteria

• Age: 45 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• All detrimental bad habits like smoking, TMJ clicking or TMJ dysfunction will be excluded.

Sponsors & Collaborators

• Mansoura University: lead

Study Sites (1)

Mansoura University ,Faculty of dentistry

Al Mansurah, P.O.Box:35516, Egypt

Location

MeSH Terms

Conditions

Prosthesis Failure

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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

Study Record Dates

• First Submitted: September 4, 2023
• First Posted: September 11, 2023
• Study Start: December 15, 2022
• Primary Completion: March 7, 2023
• Study Completion: June 16, 2024
• Last Updated: September 11, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)