NCT05990088

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

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)

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 8 (actual)
• Sponsor: Ain Shams University · Academic / Other
• Sex: All
• Age: 50 Years – 80 Years
• Healthy volunteers: Accepted

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

Conditions

• Missing Teeth
• Dentures

Interventions

Type	Name	Description
DEVICE	Heat Cured Conventional Polymethylmethacrylate Complete Removable Dentures based on neutral zone concept	The patients will receive complete removable dentures designed based on neutral zone concept and manufactured by heat cured conventional technique of polymethylmethacrylate
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 machineز

Timeline

• Start date: 2023-06-01
• Primary completion: 2024-05-01
• Completion: 2024-06-01
• First posted: 2023-08-14
• Last updated: 2024-09-05

Locations

1 site across 1 country: Egypt