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)

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.

Study Overview

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

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 Type: Interventional
• Enrollment (Actual): 8
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt, 11566
    • Faculty of dentistry, ain shams university

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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.	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
Experimental: Heat Cured Conventional 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.	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Ain Shams University
• Investigators: Principal Investigator: Omnia MS Refai, PHD, Faculty of Dentistry Ain Shams university; Principal Investigator: Omar A El-Sadat, PHD, Faculty of Dentistry Ain Shams university; Principal Investigator: Sara IS Mohamed, PHD, Faculty of Dentistry , Ain Shams Univeristy

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2023
• Primary Completion (Actual): May 1, 2024
• Study Completion (Actual): June 1, 2024

Study Registration Dates

• First Submitted: July 22, 2023
• First Submitted That Met QC Criteria: August 11, 2023
• First Posted (Actual): August 14, 2023

Study Record Updates

• Last Update Posted (Estimated): September 5, 2024
• Last Update Submitted That Met QC Criteria: September 2, 2024
• Last Verified: September 1, 2024

More Information

Terms related to this study

• Keywords: Electromyography; Denture, Complete; CAD-CAM
• Additional Relevant MeSH Terms: Congenital Abnormalities; Stomatognathic Diseases; Periodontal Diseases; Mouth Diseases; Tooth Diseases; Stomatognathic System Abnormalities; Tooth Abnormalities; Tooth Loss; Anodontia; Physiological Effects of Drugs; Vasodilator Agents; Protective Agents; Antimutagenic Agents; Polymethyl Methacrylate
• Other Study ID Numbers: FDASU-ReclR012317

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No