Dentures, Missing Teeth
Conditions
Keywords
CAD-CAM, Denture, Complete, Electromyography
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.
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: 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
Interventions
The patients will receive complete removable dentures designed based on the neutral-zone concept and digitally manufactured using a milling machineز
DEVICEHeat Cured Conventional Polymethylmethacrylate 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
Sponsors
Ain Shams University
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
50 Years to 80 Years
Healthy volunteers
Yes
Inclusion criteria
1. Patients who have been completely edentulous in both jaws (maxilla and mandible) for a long period. 2. Patients with a resorbed mandibular ridge. 3. Patients with a Class I maxillo-mandibular relationship 4. Patients with adequate inter-arch space. 5. Patients with good neuromuscular control. 6. Patients without any tempo-mandibular disorder.
Exclusion criteria
1. Patients with any oral diseases that may affect complete denture construction 2. Patients with bad oral hygiene. 3. Patients with neuromuscular disorders. 4. Patients with a history of parafunctional habits. 5. Hysterical patients. 6. Patients will undergo or have previously received chemotherapy or radiotherapy. 7. Drug-addicted patients.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
Egypt
Outcome results
None listed