Complete EdentulismNCT04999579
Digital Occlusal Analysis of Ultra Suction Retained Complete Denture
A study testing T scan in people with Complete Edentulism, run by Badr University at 1 site in Egypt.
Trial summary
Bite testing using T-Scan allows the evaluation of occlusal contacts prior to making a bite adjustment. The T-Scan can indicate premature contact and the load distribution on teeth, and provide measurable force and time information that ensures proper occlusal adjustment. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Complete Edentulism
- What is being tested?
- T scan
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Aug 2020to 1 Aug 2021
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- All implant indicated.
Who cannot join
- All implant contraindicated
Trial locations and contacts
1 site in 1 country.
About this study
Bite testing using T-Scan allows the evaluation of occlusal contacts prior to making a bite adjustment. The T-Scan can indicate premature contact and the load distribution on teeth, and provide measurable force and time information that ensures proper occlusal adjustment.
Read the detailed description
Prior to employing T-Scan occlusal analyzer to assess the occlusion on the complete denture, complete denture was seated and checked for fitness, stability, pressure areas with pressure indicating paste and border evaluation and extension. The peripheral seal should be evident so that the denture-maintained suction against maxillary tissues. Upon completion of these fit and stability assessments, the occlusion could then be addressed.
The method considered for the occlusal analysis was a computerized system . The system was composed of a computer with a specific board and software capable of converting information recorded by the sensor to visual and numerical information on tooth contact. For Tekscan system to function properly, computer system must meet or exceed specified system requirements.
The Tekscan USB handle, does not require an additional interface card or parallel box in order tobe connected to computer. When inserted into computer, the computer's operating system will automatically detect and configure the hardware for use. The T-Scan sensor was an ultra-thin (.004", 0.1 mm), flexible printed circuit that detected the patient's occlusal parameters.
- Conditions
- Complete Edentulism
- Being tested
- T scan
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
T scanDevice
Occlusal load analysis
| Study group | Role | What they receive |
|---|---|---|
| Complete denture | Active comparator | Conventional complete denture without supporting devices Receives: Device: T scan |
| Ultra suction retained complete denture | Experimental | Conventional complete denture with ultra suction device Receives: Device: T scan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Occlusal load analysis
occlusal load analysis of the ultra suction system in complete denture being evaluated by T-scan system
Measured: One year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2021
- Study start15 Aug 2020
- Primary completion20 Jul 2021
- Study completion1 Aug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Complete EdentulismStudies 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
- Device feasibility
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Badr University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shady El Naggar, Badr University
- Investigators
- El Naagar, Principal investigator, Badr university in Cairo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04999579
- Sponsor's protocol ID
- 1122110085
- Status last verified
- Aug 2021
- First submitted
- 31 Dec 2020
- Last updated
- 11 Aug 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Digital Occlusal Analysis of Ultra Suction Retained Complete Denture
- ClinicalTrials.gov ID
- NCT04999579
- Acronym / sponsor ID
- 1122110085
- Conditions
- Complete Edentulism
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Badr UniversityUniversity, hospital or other
- Study start
- 15 Aug 2020 (actual)
- Primary completion
- 20 Jul 2021 (actual)
- Study completion
- 1 Aug 2021 (actual)
- First posted
- 11 Aug 2021 (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.
Bite testing using T-Scan allows the evaluation of occlusal contacts prior to making a bite adjustment. The T-Scan can indicate premature contact and the load distribution on teeth, and provide measurable force and time information that ensures proper occlusal adjustment.
Detailed description
Prior to employing T-Scan occlusal analyzer to assess the occlusion on the complete denture, complete denture was seated and checked for fitness, stability, pressure areas with pressure indicating paste and border evaluation and extension. The peripheral seal should be evident so that the denture-maintained suction against maxillary tissues. Upon completion of these fit and stability assessments, the occlusion could then be addressed.
The method considered for the occlusal analysis was a computerized system . The system was composed of a computer with a specific board and software capable of converting information recorded by the sensor to visual and numerical information on tooth contact. For Tekscan system to function properly, computer system must meet or exceed specified system requirements.
The Tekscan USB handle, does not require an additional interface card or parallel box in order tobe connected to computer. When inserted into computer, the computer's operating system will automatically detect and configure the hardware for use. The T-Scan sensor was an ultra-thin (.004", 0.1 mm), flexible printed circuit that detected the patient's occlusal parameters.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Complete denture | Active comparator | Device: T scanConventional complete denture without supporting devices |
| Ultra suction retained complete denture | Experimental | Device: T scanConventional complete denture with ultra suction device |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- All implant indicated.
Key exclusion criteria (1 listed)
- All implant contraindicated
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 |
|---|---|---|
| T scanOcclusal load analysis | Device | Complete denture, Ultra suction retained complete denture |
Primary outcome
Occlusal load analysis
Time frame: One year
occlusal load analysis of the ultra suction system in complete denture being evaluated by T-scan system
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 11 Aug 2021.
- Individual participant dataSharing planned: No
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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.
El Naagar principal investigator
Badr university in Cairo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing T scan in people with Complete Edentulism, run by Badr 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 1 inclusion and 1 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 11 Aug 2021. 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?
Occlusal load analysis (time frame: One year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 11 Aug 2021; AzTrials last refreshed its copy on 7 Nov 2026.