Missing TeethNCT05990088
Comparison Between Conventional and CAD/CAM Complete Dentures Designed Based on Neutral Zone Concept
A study testing 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 people with Missing Teeth and Dentures, run by Ain Shams University at 1 site in Egypt.
Trial 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… Read more about this study
- Who is it for?
- Ages 50 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Missing Teeth, Dentures
- What is being tested?
- 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.
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jun 2023to 1 Jun 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients who have been completely edentulous in both jaws (maxilla and mandible) for a long period.
- Patients with a resorbed mandibular ridge.
- Patients with a Class I maxillo-mandibular relationship
- Patients with adequate inter-arch space.
- Patients with good neuromuscular control.
- Patients without any tempo-mandibular disorder.
Who cannot join
- Patients with any oral diseases that may affect complete denture construction
- Patients with bad oral hygiene.
- Patients with neuromuscular disorders.
- Patients with a history of parafunctional habits.
- Hysterical patients.
- Patients will undergo or have previously received chemotherapy or radiotherapy.
- Drug-addicted patients.
Trial locations and contacts
1 site in 1 country.
About this study
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)
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.
Read the 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
- Conditions
- Missing Teeth, Dentures
- Being tested
- Heat Cured Conventional Polymethylmethacrylate Complete Removable Dentures based on neutral zone concept, CAD/CAM Milled Methacrylate Complete Removable Dentures based on neutral zone concept.
- Keywords
- CAD-CAM, Denture, Complete, Electromyography
- Medical subject headings
- Anodontia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Heat Cured Conventional Polymethylmethacrylate Complete Removable Dentures based on neutral zone conceptDevice
The patients will receive complete removable dentures designed based on neutral zone concept and manufactured by heat cured conventional technique of polymethylmethacrylate
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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Heat Cured Conventional Polymethylmethacrylate Complete Removable Dentures based on neutral zone concept |
| 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. Receives: Device: CAD/CAM Milled Methacrylate Complete Removable Dentures based on neutral zone concept. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: one month
Secondary outcomes (1)
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.
Measured: two weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2023
- Study start1 Jun 2023
- Primary completion1 May 2024
- Study completion1 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Missing TeethStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Omnia M. Refai, Ain Shams University
- Investigators
- Omnia MS Refai, PHD, Principal investigator, Faculty of Dentistry Ain Shams UniversityOmar A El-Sadat, PHD, Principal investigator, Faculty of Dentistry Ain Shams UniversitySara IS Mohamed, PHD, Principal investigator, Faculty of Dentistry , Ain Shams Univeristy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05990088
- Sponsor's protocol ID
- FDASU-ReclR012317
- Status last verified
- Sep 2024
- First submitted
- 22 Jul 2023
- Last updated
- 5 Sep 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 28720338Cagna 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.
PubMed 19463668
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT05990088
- Acronym / sponsor ID
- FDASU-ReclR012317
- Conditions
- Missing Teeth, Dentures
- Keywords
- CAD-CAM, Denture, Complete, Electromyography
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 1 Jun 2023 (actual)
- Primary completion
- 1 May 2024 (actual)
- Study completion
- 1 Jun 2024 (actual)
- First posted
- 14 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Heat Cured Conventional Complete Removable Dentures based on neutral zone concept | Experimental | Device: Heat Cured Conventional Polymethylmethacrylate Complete Removable Dentures based on neutral zone conceptThe 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. |
| CAD/CAM Milled Methacrylate Complete Removable Dentures based on neutral zone concept. | Active comparator | Device: 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. |
Who may qualify
- Ages
- 50 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patients who have been completely edentulous in both jaws (maxilla and mandible) for a long period.
- Patients with a resorbed mandibular ridge.
- Patients with a Class I maxillo-mandibular relationship
- Patients with adequate inter-arch space.
- Patients with good neuromuscular control.
Key exclusion criteria (7 listed)
- Patients with any oral diseases that may affect complete denture construction
- Patients with bad oral hygiene.
- Patients with neuromuscular disorders.
- Patients with a history of parafunctional habits.
- Hysterical patients.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Heat Cured Conventional Polymethylmethacrylate Complete Removable Dentures based on neutral zone conceptThe patients will receive complete removable dentures designed based on neutral zone concept and manufactured by heat cured conventional technique of polymethylmethacrylate | Device | Heat Cured Conventional Complete Removable Dentures based on neutral zone concept |
| 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 | Device | CAD/CAM Milled Methacrylate Complete Removable Dentures based on neutral zone concept. |
Primary outcome
Evaluation of the electromyography muscle activity (EMG) of the masseter and temporalis muscles.
Time frame: 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.
1 secondary outcome
Evaluation of occlusal force equilibration using t-scan device
Time frame: two weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Sep 2024.
- Background: PubMed 28720338Ohkubo 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.
- Results publication: PubMed 19463668Cagna 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Omnia MS Refai, PHD principal investigator
Faculty of Dentistry Ain Shams University
Omar A El-Sadat, PHD principal investigator
Faculty of Dentistry Ain Shams University
Sara IS Mohamed, PHD principal investigator
Faculty of Dentistry , Ain Shams Univeristy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 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 people with Missing Teeth and Dentures, run by Ain Shams University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation of the electromyography muscle activity (EMG) of the masseter and temporalis muscles. (time frame: one month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05990088, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Sep 2024.