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)
1 other identifier
interventional
8
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jun 2023
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2023
CompletedFirst Submitted
Initial submission to the registry
July 22, 2023
CompletedFirst Posted
Study publicly available on registry
August 14, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2024
CompletedSeptember 5, 2024
September 1, 2024
11 months
July 22, 2023
September 2, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
Evaluation of occlusal force equilibration using t-scan device
two weeks
Study Arms (2)
Heat Cured Conventional Complete Removable Dentures based on neutral zone concept
EXPERIMENTALThe 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.
CAD/CAM Milled Methacrylate Complete Removable Dentures based on neutral zone concept.
ACTIVE COMPARATORThe 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.
Interventions
The patients will receive complete removable dentures designed based on neutral zone concept and manufactured by heat cured conventional technique of polymethylmethacrylate
The patients will receive complete removable dentures designed based on the neutral-zone concept and digitally manufactured using a milling machineز
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Faculty of Dentistry, Ain shams University
Cairo, 11566, Egypt
Related Publications (2)
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.
PMID: 28720338BACKGROUNDCagna 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.
PMID: 19463668RESULT
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- 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
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Lecturer of Oral and Maxillofacial Prosthodontics, Faculty of Dentistry, Ain Shams Univeristy
Study Record Dates
First Submitted
July 22, 2023
First Posted
August 14, 2023
Study Start
June 1, 2023
Primary Completion
May 1, 2024
Study Completion
June 1, 2024
Last Updated
September 5, 2024
Record last verified: 2024-09