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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.
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Heat Cured Conventional Complete Removable Dentures based on neutral zone concept | Experimental | 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. |
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| CAD/CAM Milled Methacrylate Complete Removable Dentures based on neutral zone concept. | Active Comparator | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Heat Cured Conventional Polymethylmethacrylate Complete Removable Dentures based on neutral zone concept | Device | The patients will receive complete removable dentures designed based on neutral zone concept and manufactured by heat cured conventional technique of polymethylmethacrylate |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| 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 | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Faculty of Dentistry, Ain shams University | Cairo | 11566 | Egypt |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28720338 | Background | 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. | |
| 19463668 | Result | 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. |
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| CAD/CAM Milled Methacrylate Complete Removable Dentures based on neutral zone concept. | Device | The patients will receive complete removable dentures designed based on the neutral-zone concept and digitally manufactured using a milling machineز |
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| ID | Term |
|---|---|
| D000848 | Anodontia |
| ID | Term |
|---|---|
| D014071 | Tooth Abnormalities |
| D018640 | Stomatognathic System Abnormalities |
| D009057 | Stomatognathic Diseases |
| D014076 | Tooth Diseases |
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
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