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

Missing Teeth Clinical Trial

Official 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)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05990088
• Other study ID #: FDASU-ReclR012317
• Status: Recruiting
• Phase: N/A
• 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
• 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.

Related Conditions & MeSH terms

• Anodontia
• Dentures
• Missing Teeth
• Tooth Loss

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