search
Back to results

Comparison Between Conventional and Neutral Zone CAD/CAM Complete Dentures in Muscle Activity and Occlusal Accuracy

Primary Purpose

Missing Teeth, Dentures

Status
Recruiting
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
CAD/CAM Milled Methacrylate Complete Removable Dentures based on the software algorithms
CAD/CAM Milled Methacrylate Complete Removable Dentures based on neutral zone concept.
Sponsored by
Ain Shams University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Missing Teeth focused on measuring CAD-CAM, Denture, Complete, Electromyography

Eligibility Criteria

50 Years - 80 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: Patients who have been completely edentulous in both jaws (maxilla and mandible) for a long period. Patients with a resorbed mandibular ridge. Patients with a Class I maxillo-mandibular relationship Patients with adequate inter-arch space. Patients with good neuromuscular control. Patients without any tempo-mandibular disorder. Exclusion Criteria: Patients with any oral diseases that may affect complete denture construction Patients with bad oral hygiene. Patients with neuromuscular disorders. Patients with a history of parafunctional habits. Hysterical patients. Patients will undergo or have previously received chemotherapy or radiotherapy. Drug-addicted patients.

Sites / Locations

  • Faculty of Dentistry, Ain shams UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

CAD/CAM Milled Methacrylate Complete Removable Dentures based on the software algorithms

CAD/CAM Milled Methacrylate Complete Removable Dentures based on neutral zone concept.

Arm Description

The patient will be provided by a complete removable denture designed based on the software algorithms to restore his missing teeth which will be manufactured by CAD/CAM milling of monolithic methacrylate blanks.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

First Posted
July 22, 2023
Last Updated
August 11, 2023
Sponsor
Ain Shams University
search

1. Study Identification

Unique Protocol Identification Number
NCT05990088
Brief Title
Comparison Between Conventional and Neutral Zone CAD/CAM Complete Dentures in Muscle Activity and Occlusal Accuracy
Official Title
Comparison of Electromyographic Muscle Activity and Occlusal Accuracy Between Conventional and Neutral Zone CAD/CAM Complete Dentures (Randomized Controlled Clinical Trial)
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 1, 2023 (Actual)
Primary Completion Date
October 1, 2023 (Anticipated)
Study Completion Date
December 1, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ain Shams University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
A within-subject cross-over study is done on eight completely edentulous patients to compare two different complete removable dentures. Group I: CAD-CAM ( computer-aided design/computer-aided manufacturing) conventional complete dentures designed based on the software algorithms; 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: CAD-CAM conventional complete dentures designed based on the software algorithms, 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Missing Teeth, Dentures
Keywords
CAD-CAM, Denture, Complete, Electromyography

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
8 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
CAD/CAM Milled Methacrylate Complete Removable Dentures based on the software algorithms
Arm Type
Experimental
Arm Description
The patient will be provided by a complete removable denture designed based on the software algorithms to restore his missing teeth which will be manufactured by CAD/CAM milling of monolithic methacrylate blanks.
Arm Title
CAD/CAM Milled Methacrylate Complete Removable Dentures based on neutral zone concept.
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
CAD/CAM Milled Methacrylate Complete Removable Dentures based on the software algorithms
Intervention Description
The patients will receive complete removable dentures designed based on the software algorithms and digitally manufactured using a milling machine.
Intervention Type
Device
Intervention Name(s)
CAD/CAM Milled Methacrylate Complete Removable Dentures based on neutral zone concept.
Intervention Description
The patients will receive complete removable dentures designed based on the neutral-zone concept and digitally manufactured using a milling machineز
Primary Outcome Measure Information:
Title
Evaluation of the electromyography muscle activity (EMG) of the masseter and temporalis muscles.
Description
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.
Time Frame
one month
Secondary Outcome Measure Information:
Title
Evaluation of occlusal force equilibration using t-scan device
Description
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.
Time Frame
two weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Patients who have been completely edentulous in both jaws (maxilla and mandible) for a long period. Patients with a resorbed mandibular ridge. Patients with a Class I maxillo-mandibular relationship Patients with adequate inter-arch space. Patients with good neuromuscular control. Patients without any tempo-mandibular disorder. Exclusion Criteria: Patients with any oral diseases that may affect complete denture construction Patients with bad oral hygiene. Patients with neuromuscular disorders. Patients with a history of parafunctional habits. Hysterical patients. Patients will undergo or have previously received chemotherapy or radiotherapy. Drug-addicted patients.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Omnia MS Refai, PHD
Phone
+201202420046
Ext
+02
Email
omnia_refaie@dent.asu.edu.eg
First Name & Middle Initial & Last Name or Official Title & Degree
Sara IS Mohamed, PHD
Phone
01285446141
Ext
+02
Email
Saraibrahim@dent.asu.edu.eg
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Omnia MS Refai, PHD
Organizational Affiliation
Faculty of Dentistry Ain Shams University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Omar A El-Sadat, PHD
Organizational Affiliation
Faculty of Dentistry Ain Shams University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Sara IS Mohamed, PHD
Organizational Affiliation
Faculty of Dentistry , Ain Shams Univeristy
Official's Role
Principal Investigator
Facility Information:
Facility Name
Faculty of Dentistry, Ain shams University
City
Cairo
ZIP/Postal Code
11566
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Omnia MS Refai, PHD
Phone
01202420046
Ext
+02
Email
omnia_refaie@dent.asu.edu.eg
First Name & Middle Initial & Last Name & Degree
Sara IS Mohamed, PHD
Phone
01285446141
Ext
+02
Email
Saraibrahim@dent.asu.edu.eg

12. IPD Sharing Statement

Citations:
PubMed Identifier
28720338
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.
Results Reference
background
PubMed Identifier
19463668
Citation
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.
Results Reference
result

Learn more about this trial

Comparison Between Conventional and Neutral Zone CAD/CAM Complete Dentures in Muscle Activity and Occlusal Accuracy

We'll reach out to this number within 24 hrs