NCT06332482

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2023

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 30, 2023

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

October 10, 2023

Completed
6 months until next milestone

First Posted

Study publicly available on registry

March 27, 2024

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 20, 2024

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 20, 2024

Completed
Last Updated

January 17, 2025

Status Verified

December 1, 2024

Enrollment Period

1.1 years

First QC Date

October 10, 2023

Last Update Submit

January 15, 2025

Conditions

Prosthesis Durability

Outcome Measures

Primary Outcomes (2)

  • 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

Study Arms (3)

Group 1

ACTIVE COMPARATOR

Patients who will use surgical stent in recording the digital Jaw relation

Device: Implant supported screw retained prosthesis

Group 2

ACTIVE COMPARATOR

Patients who will use acrylic complete denture in recording the digital Jaw relation

Device: Implant supported screw retained prosthesis

Group 3

ACTIVE COMPARATOR

Patients who will use mandibular stent in recording the digital Jaw relation

Device: Implant supported screw retained prosthesis

Interventions

Implant supported screw retained prosthesisDEVICE

All patients will receive six maxillary and mandibular implants for full arch screw retained prosthesis

Group 1Group 2Group 3

Eligibility Criteria

Age45 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

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 ComplicationsPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
CROSSOVER
Model Details: digital impressions will be made for each patient,3 technique will be used to determine intermaxillary relation. Occlusal prematurties of final prosthesis will compared using occlusense device and all patients will be followed up for one year
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 10, 2023

First Posted

March 27, 2024

Study Start

March 30, 2023

Primary Completion

May 20, 2024

Study Completion

December 20, 2024

Last Updated

January 17, 2025

Record last verified: 2024-12

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)