Clinical trial NCT05990088: Comparison Between Conventional and CAD/CAM Complete Dentures Designed Based on Neutral Zone Concept
Official title: 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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Missing Teeth
Dentures
Keywords: CAD-CAM
Denture, Complete
Electromyography
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2023-08-14
Enrollment: 8
Sex: ALL
Minimum age (years): 50
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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

Eligibility criteria: 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.

Primary outcomes:
measure: Evaluation of the electromyography muscle activity (EMG) of the masseter and temporalis muscles.
timeFrame: one month
Secondary outcomes:
measure: Evaluation of occlusal force equilibration using t-scan device
timeFrame: two weeks
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Faculty of Dentistry, Ain shams University
Study officials:
affiliation: Faculty of Dentistry Ain Shams University
name: Omnia MS Refai, PHD
role: PRINCIPAL_INVESTIGATOR
affiliation: Faculty of Dentistry Ain Shams University
name: Omar A El-Sadat, PHD
role: PRINCIPAL_INVESTIGATOR
affiliation: Faculty of Dentistry , Ain Shams Univeristy
name: Sara IS Mohamed, PHD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.