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Completed

NCT Number: NCT05990088

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

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.

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Key information

Age range

50 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of Dentistry, Ain shams University

Cairo, 11566, Egypt

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

Device

The patients will receive complete removable dentures designed based on neutral zone concept and manufactured by heat cured conventional technique of polymethylmethacrylate

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

Device

The patients will receive complete removable dentures designed based on the neutral-zone concept and digitally manufactured using a milling machineز

Primary outcomes

  1. 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

  1. Evaluation of occlusal force equilibration using t-scan device

    Time frame: two weeks

    The percentage of occlusal force distribution will be evaluated for both dentures using the T-Scan computerized occlusal analysis system, at the time of denture insertion (baseline) and following baseline by two weeks after.

Sponsors and collaborators

Lead sponsor

Ain Shams University

Other

Registry information

Official study title

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)

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Aug 14, 2023
Registry last updated
Sep 5, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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