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

Not Applicable

Recruiting

• Conditions: Dentures; Missing Teeth
• Interventions: Device: Heat Cured Conventional Polymethylmethacrylate Complete Removable Dentures based on neutral zone concept; Device: CAD/CAM Milled Methacrylate Complete Removable Dentures based on neutral zone concept.

• Registration Number: NCT05990088
• Lead Sponsor: Ain Shams University

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

Study Timeline

• Study Start: 2023-06-01
• Study First Submitted: 2023-07-22
• Study First Submitted QC: 2023-08-11
• Study First Posted: 2023-08-14
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-04
• Last Update Posted: 2024-03-05
• Primary Completion: 2024-05-01
• Study Completion: 2024-06-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 8

Inclusion Criteria

1. Patients who have been completely edentulous in both jaws (maxilla and mandible) for a 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 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

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Heat Cured Conventional Complete Removable Dentures based on neutral zone concept	Heat Cured Conventional Polymethylmethacrylate Complete Removable Dentures based on neutral zone concept	The patient will be provided by a complete removable denture designed based on the neutral zone concept to restore his missing teeth which will be manufactured by heat curing of Polymethyl methacrylate.
CAD/CAM Milled Methacrylate Complete Removable Dentures based on neutral zone concept.	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.

Primary Outcome Measures

Name	Time	Method
Evaluation of the electromyography muscle activity (EMG) of the masseter and temporalis muscles.	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 Outcome Measures

Name	Time	Method
Evaluation of occlusal force equilibration using t-scan device	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.

Trial Locations

Locations (1)

Faculty of Dentistry, Ain shams University; 🇪🇬 Cairo, Egypt