Comparison Between Conventional and Neutral Zone CAD/CAM Complete Dentures in Muscle Activity and Occlusal Accuracy
Study Details
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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N/A |
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
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: CAD/CAM Milled Methacrylate Complete Removable Dentures based on the software algorithms 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. |
Device: CAD/CAM Milled Methacrylate Complete Removable Dentures based on the software algorithms
The patients will receive complete removable dentures designed based on the software algorithms and digitally manufactured using a milling machine.
|
| 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
|
Outcome Measures
Primary Outcome Measures
- Evaluation of the electromyography muscle activity (EMG) of the masseter and temporalis muscles. [one month]
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 [two weeks]
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.
Eligibility Criteria
Criteria
Inclusion Criteria:
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Patients who have been completely edentulous in both jaws (maxilla and mandible) for a long period.
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Patients with a resorbed mandibular ridge.
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Patients with a Class I maxillo-mandibular relationship
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Patients with adequate inter-arch space.
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Patients with good neuromuscular control.
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Patients without any tempo-mandibular disorder.
Exclusion Criteria:
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Patients with any oral diseases that may affect complete denture construction
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Patients with bad oral hygiene.
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Patients with neuromuscular disorders.
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Patients with a history of parafunctional habits.
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Hysterical patients.
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Patients will undergo or have previously received chemotherapy or radiotherapy.
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Drug-addicted patients.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Faculty of Dentistry, Ain shams University | Cairo | Egypt | 11566 |
Sponsors and Collaborators
- 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
Study Documents (Full-Text)
None provided.More Information
Publications
- FDASU-ReclR012317