Impact of Mandibular Overdenture Base Construction Techniques on Assessment of Occlusion

October 8, 2023 updated by: Mansoura University

Impact of Mandibular 4-Implant Overdenture Base Construction Techniques on Assessment of Occlusion With Digital Occlusion Analysis System (Within Patient Study)

This within patient study will be conducted to compare between two different construction techniques (CAD-CAM Milled and Conventional techniques) of 4-implant-assisted complete mandibular overdenture bases regarding the digital occlusion force balance analysis using the OccluSense

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Mansoura, Egypt, 35516
        • Mansoura University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • 1. Free from any systemic diseases that contraindicate dental implantation. 2. Angel's class I maxillo- mandibular relation. 3. Available inter-arch space and sufficient restorative space. 4. Nonsmokers, non-alcoholics. 5. Complaints from their conventional denture

Exclusion Criteria:

  • diabetic and heavy smoker patients

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Group I: patients receive maxillary complete denture opposed to conventional mandibular overdenture
Device: CAD/CAM Complete denture
four implant-supported CAD/CAM complete overdenture
Active Comparator: Group II: patients receive maxillary complete denture opposed CAD/CAM overdenture
Device: CAD/CAM Complete denture
four implant-supported CAD/CAM complete overdenture

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
digital occlusal analysis
Time Frame: 6 months
occlusion was analyzed by occlusense device
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mansoura University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 10, 2022

Primary Completion (Actual)

December 15, 2022

Study Completion (Actual)

March 7, 2023

Study Registration Dates

First Submitted

October 8, 2023

First Submitted That Met QC Criteria

October 8, 2023

First Posted (Actual)

October 12, 2023

Study Record Updates

Last Update Posted (Actual)

October 12, 2023

Last Update Submitted That Met QC Criteria

October 8, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 05201021

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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