Conventional Versus Neutral-Zone CAD/CAM Dentures Restoring Mandibular Resorbed Ridges (CAD/CAM)

January 11, 2024 updated by: Omnia M Refai, Ain Shams University

Digital Analysis of Denture Space Confines and Patient's Satisfaction for Conventional Versus Neutral-Zone CAD/CAM Dentures Restoring Mandibular Resorbed Ridges.(Randomized Controlled Clinical Trial)

The study is a within-subject randomized clinical trial that will compare and evaluate patients' satisfaction and digitally analyze denture space Confines. Group I: CAD/CAM. (computer-aided design/computer-aided manufacturing) Conventional complete dentures will be designed based on the bone support concept, Group II: CAD/CAM neutral zone complete dentures will be designed based on the neutral zone concept. The participants will be selected according to inclusion and exclusion criteria and will be randomly allocated into both groups and then shuffled to the other group using the Research Randomizer Program.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

This study is designed as a randomized clinical trial applying a within-subject comparison of two different complete denture types as follows; group I: CAD/CAM conventional complete dentures will be designed based on the bone support concept, group II: CAD/CAM neutral zone complete dentures will be designed based on the neutral zone concept. The study will be carried out on twelve completely edentulous patients exhibiting advanced residual ridge resorption, each patient will receive two sets of complete dentures in a random sequence, and each set of CDs will be worn for at least eight weeks after the last recall visit before assessments. Upon delivery of the second set of CDs, the first set will be withheld from the patient. For each denture set, patient satisfaction will be rated using a patient denture assessment PDA questionnaire that will be assessed via a Likert scale, the obtained scores will be used to compare the two denture types. Also by using special digital software, a comparison between group I and II virtual complete denture images will be conducted.

Study Type

Interventional

Enrollment (Estimated)

12

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 Contact

Study Contact Backup

Study Locations

  • Egypt
    • Nasr City
      • Cairo, Nasr City, Egypt, 11566
        • Recruiting
        • Faculty of Dentistry, Ain Shams University
        • Contact:
        • Contact:
        • Principal Investigator:
          • Omnia MS Refai, PHD
        • Principal Investigator:
          • Sara IS Mohamed, PHD
        • Sub-Investigator:
          • Abdelrahman A Nosair, Bachelor

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. Patients who have been completely edentulous in both jaws (maxilla and mandible) for a long period.
  2. The age of patients ranges from 50 to 80 years old.
  3. Patients with a resorbed mandibular ridge.
  4. Patients with a Class I maxillo-mandibular relationship
  5. Patients with adequate inter-arch space.
  6. Patients with good neuromuscular control.
  7. Patients without any tempo-mandibular disorder.

Exclusion Criteria:

  1. Patients with any oral diseases that may affect complete denture construction
  2. Patients with bad oral hygiene.
  3. Patients with oral parafunctional habits.
  4. Hysterical patients.
  5. Patients will undergo or have previously received chemotherapy or radiotherapy.
  6. Drug-addicted 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: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: CAD/CAM Milled Methacrylate Complete Removable Dentures based on bone-support concept.
The patient will be provided by a complete removable denture designed according to bone-support concept to restore his missing teeth which will be manufactured by CAD/CAM milling of monolithic methacrylate blanks.
Device: CAD/CAM Milled Methacrylate Complete Removable Dentures based on bone-support concept.
The patients will receive complete removable dentures designed based on the bone-support concept and digitally manufactured using a milling machine.
Active Comparator: CAD/CAM Milled Methacrylate Complete Removable Dentures based on neutral zone concept.
The patient will be provided with a complete removable denture designed according to the neutral-concept to restore his missing teeth, which will be manufactured by CAD/CAM milling of monolithic methacrylate blanks.
Device: CAD/CAM Milled Methacrylate Complete Removable Dentures based on neutral zone concept.
The patients will receive complete removable dentures designed based on the neutral-zone concept and digitally manufactured using a milling machine

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Digital Analysis and Comparison of Denture Space Confines for CAD/CAM Dentures Based on the bone-support concept Versus based on the neutral-zone concept Restoring Mandibular Resorbed Ridges using "Medit compare" digital software.
Time Frame: before manufacturing of complete removable denture
comparing the position of the neutral zone to the software-designed anatomical denture confines using "Medit compare" digital software (Medit design, Medit Compare (V1.2), Seoul, South Korea). Average values of facio-lingual deviations between the two dentures in the premolar and molar regions, as well as the anterior region, will be calculated in millimeters, yielding five measurements for each patient's denture sets. Color maps for dimensional deviations of the overall as well as specified surfaces for both dentures revealing the qualitative 3D differences between them will be obtained. Measuring procedures will be similar, as recommended by the manufacturer and all will be performed by the same digital professional operator.
before manufacturing of complete removable denture

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluation of patients' satisfaction with both types of the Complete Removable Dentures
Time Frame: three months
Evaluation of patients' satisfaction with both types of the Complete Removable Dentures by using Patient's Denture Assessment questionnaire (PDA) and interpreting it by using Likert scale (higher score (scale no.5) indicates good outcome and lower score (scale no.1)indicates bad outcome)
three months

Collaborators and Investigators

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

Sponsor

Ain Shams University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

March 1, 2023

Primary Completion (Estimated)

March 1, 2024

Study Completion (Estimated)

April 1, 2024

Study Registration Dates

First Submitted

May 31, 2023

First Submitted That Met QC Criteria

June 7, 2023

First Posted (Actual)

June 8, 2023

Study Record Updates

Last Update Posted (Actual)

January 12, 2024

Last Update Submitted That Met QC Criteria

January 11, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • FDASU-RecIR012316

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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