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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05990088
Other study ID # FDASU-ReclR012317
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date June 1, 2023
Est. completion date June 1, 2024

Study information

Verified date March 2024
Source Ain Shams University
Contact Omnia MS Refai, PHD
Phone +201202420046
Email omnia_refaie@dent.asu.edu.eg
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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


Recruitment information / eligibility

Status Recruiting
Enrollment 8
Est. completion date June 1, 2024
Est. primary completion date May 1, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 50 Years to 80 Years
Eligibility 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


Related Conditions & MeSH terms


Intervention

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
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 machine?

Locations

Country Name City State
Egypt Faculty of Dentistry, Ain shams University Cairo

Sponsors (1)

Lead Sponsor Collaborator
Ain Shams University

Country where clinical trial is conducted

Egypt, 

References & Publications (2)

Cagna DR, Massad JJ, Schiesser FJ. The neutral zone revisited: from historical concepts to modern application. J Prosthet Dent. 2009 Jun;101(6):405-12. doi: 10.1016/S0022-3913(09)60087-1. — View Citation

Ohkubo C, Shimpo H, Tokue A, Park EJ, Kim TH. Complete denture fabrication using piezography and CAD-CAM: A clinical report. J Prosthet Dent. 2018 Mar;119(3):334-338. doi: 10.1016/j.prosdent.2017.04.013. Epub 2017 Jul 15. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Evaluation of the electromyography muscle activity (EMG) of the masseter and temporalis muscles. 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. one month
Secondary Evaluation of occlusal force equilibration using t-scan device 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. two weeks
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