Comparison Between Conventional and CAD/CAM Complete Dentures Designed Based on Neutral Zone Concept

Last updated: September 2, 2024
Sponsor: Ain Shams University
Overall Status: Completed

Phase

N/A

Condition

Periodontitis

Treatment

CAD/CAM Milled Methacrylate Complete Removable Dentures based on neutral zone concept.

Heat Cured Conventional Polymethylmethacrylate Complete Removable Dentures based on neutral zone concept

CAD/CAM Milled Methacrylate Complete Removable Dentures based on the software algorithms

Clinical Study ID

NCT05990088
FDASU-ReclR012317
  • Ages 50-80
  • All Genders
  • Accepts Healthy Volunteers

Study Summary

A within-subject cross-over study is done on eight completely edentulous patients to compare two different complete removable dentures. Group I: Heat cured Conventional complete dentures designed based on the neutral zone concept; Group II: CAD-CAM neutral zone complete dentures designed based on the neutral zone concept. Occlusal analysis is done by the T-Scan device, and evaluation of muscle activity is conducted by electromyography at insertion time, two weeks after insertion time, and one month after insertion time.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Patients who have been completely edentulous in both jaws (maxilla and mandible) fora long period.

  2. Patients with a resorbed mandibular ridge.

  3. Patients with a Class I maxillo-mandibular relationship

  4. Patients with adequate inter-arch space.

  5. Patients with good neuromuscular control.

  6. Patients without any tempo-mandibular disorder.

Exclusion

Exclusion Criteria:

  1. Patients with any oral diseases that may affect complete denture construction

  2. Patients with bad oral hygiene.

  3. Patients with neuromuscular disorders.

  4. Patients with a history of parafunctional habits.

  5. Hysterical patients.

  6. Patients will undergo or have previously received chemotherapy or radiotherapy.

  7. Drug-addicted patients.

Study Design

Total Participants: 8
Treatment Group(s): 3
Primary Treatment: CAD/CAM Milled Methacrylate Complete Removable Dentures based on neutral zone concept.
Phase:
Study Start date:
June 01, 2023
Estimated Completion Date:
June 01, 2024

Study 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: Heat cured Conventional complete dentures designed based on the neutral zone concept, group II: CAD-CAM neutral zone complete dentures designed based on the neutral zone concept. The study will be carried out on eight completely edentulous patients, each patient will receive two sets of complete dentures in a random sequence. For each denture set, at the denture insertion visit occlusal analysis and equilibration will be performed with the aid of the T-Scan device, also EMG evaluation of muscle activity will be conducted. Two weeks after, the patients will be recalled to reanalyze the occlusion after the denture settles using the T-scan computerized system. One month after the last recall visit, the EMG evaluation of muscle activity will be conducted again. The EMG and T-scan recording data will be collected and analyzed to compare the two denture types

Connect with a study center

  • Faculty of Dentistry, Ain shams University

    Cairo, 11566
    Egypt

    Site Not Available

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