Complete Digital Workflow for Construction of Full Arch Implant Supported Screw Retained Restoration

Complete Digital Workflow for Construction of Full Arch Implant Supported Screw Retained Restoration :occlusal Accuracy of Different Techniques Used to Record Maxillo-mandibular Relationship(Crossover Study)

This study will compare the occlusal accuracy of different techniques for recording maxillomandibular relationships in a Complete digital workflow to construct full arch implant-supported screw-retained restoration.

Study Overview

• Status: Completed
• Conditions: Prosthesis Durability
• Intervention / Treatment: Device: Implant supported screw retained prosthesis

• Study Type: Interventional
• Enrollment (Actual): 10
• 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:

• • Inclusion criteria: i- complete maxillary and mandibular edentulous arches ii- residual alveolar ridges covered with healthy firmly attached mucosa. iii- Angel's class I maxillo-mandibular relationship and iv- Adequate bone height and width for placement of standard diameter implants.

Exclusion Criteria:

• History of drug administration that interfere with bone quality ii- Surgical contraindication (patients under anticoagulant ,immunosuppressive drugs, chemotherapy and irradiation therapy) iv- tempromandibular or myoneurological disorders.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Group 1; Patients who will use surgical stent in recording the digital Jaw relation	Device: Implant supported screw retained prosthesis; All patients will receive six maxillary and mandibular implants for full arch screw retained prosthesis
Active Comparator: Group 2; Patients who will use acrylic complete denture in recording the digital Jaw relation	Device: Implant supported screw retained prosthesis; All patients will receive six maxillary and mandibular implants for full arch screw retained prosthesis
Active Comparator: Group 3; Patients who will use mandibular stent in recording the digital Jaw relation	Device: Implant supported screw retained prosthesis; All patients will receive six maxillary and mandibular implants for full arch screw retained prosthesis

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
measurement of occlusal prematurity	Occlusal prematureties of final prosthesis will be measured using occlusense device	one year
prosthestic complications	prosthetic complications will be recorded for all patients and statistically analyzed	one year

Collaborators and Investigators

• Sponsor: Mansoura University

Study record dates

Study Major Dates

• Study Start (Actual): March 30, 2023
• Primary Completion (Actual): May 20, 2024
• Study Completion (Actual): December 20, 2024

Study Registration Dates

• First Submitted: October 10, 2023
• First Submitted That Met QC Criteria: March 19, 2024
• First Posted (Actual): March 27, 2024

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 15, 2025
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Postoperative Complications; Pathologic Processes; Prosthesis Failure
• Other Study ID Numbers: M0303023RP

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
• product manufactured in and exported from the U.S.: No