An interventional study of Heat Cured Conventional Polymethylmethacrylate Complete Removable Dentures based on neutral zone concept and CAD/CAM Milled Methacrylate Complete Removable Dentures based on neutral zone concept. in Missing Teeth and Dentures, sponsored by Ain Shams University. Completed at 1 site in Egypt. Open to participants aged 50 Years to 80 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-09-05.
Sponsored by Ain Shams University · Not applicable, Interventional, and Treatment
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
90 studies on the registry are indexed under Anodontia; 23 are open to participants now.
This study's enrollment of 8 is below the median of 30 across 66 interventional studies indexed under Anodontia.
Browse Anodontia studies →Ain Shams University is the lead sponsor of 1,932 studies on the registry; 433 are open to participants now.
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Exclusion Criteria:
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 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 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
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.
Time frame: one month
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.
Time frame: two weeks
This study is completed, as verified in Sep 2024. You cannot join it, but the record below documents what was studied.
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