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Clinical Trials/NCT05990088
NCT05990088
Recruiting
Not Applicable

Comparison of Electromyographic Muscle Activity and Occlusal Accuracy Between Conventional and CAD/CAM Complete Dentures Designed Based on Neutral Zone Concept (Randomized Controlled Clinical Trial)

Ain Shams University1 site in 1 country8 target enrollmentJune 1, 2023

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Missing Teeth
Sponsor
Ain Shams University
Enrollment
8
Locations
1
Primary Endpoint
Evaluation of the electromyography muscle activity (EMG) of the masseter and temporalis muscles.
Status
Recruiting
Last Updated
2 years ago

Overview

Brief 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.

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: 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

Registry
clinicaltrials.gov
Start Date
June 1, 2023
End Date
June 1, 2024
Last Updated
2 years ago
Study Type
Interventional
Study Design
Crossover
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Omnia M Refai

Lecturer of Oral and Maxillofacial Prosthodontics, Faculty of Dentistry, Ain Shams Univeristy

Ain Shams University

Eligibility Criteria

Inclusion Criteria

  • Patients who have been completely edentulous in both jaws (maxilla and mandible) for a long period.
  • Patients with a resorbed mandibular ridge.
  • Patients with a Class I maxillo-mandibular relationship
  • Patients with adequate inter-arch space.
  • Patients with good neuromuscular control.
  • Patients without any tempo-mandibular disorder.

Exclusion Criteria

  • Patients with any oral diseases that may affect complete denture construction
  • Patients with bad oral hygiene.
  • Patients with neuromuscular disorders.
  • Patients with a history of parafunctional habits.
  • Hysterical patients.
  • Patients will undergo or have previously received chemotherapy or radiotherapy.
  • Drug-addicted patients.

Outcomes

Primary Outcomes

Evaluation of the electromyography muscle activity (EMG) of the masseter and temporalis muscles.

Time Frame: one month

The electromyography activity of the Masseter and Temporalis muscles will be evaluated during clenching, chewing of soft food, and chewing of hard food, at the time of denture insertion (baseline) and one month after baseline.The measuring unit is mv.

Secondary Outcomes

  • Evaluation of occlusal force equilibration using t-scan device(two weeks)

Study Sites (1)

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