OcclusionNCT05051878
Effect of T-scan Occlusal Analysis and Adjustment vs Articulating
A study testing T-scan and articulating paper in people with Occlusion, run by Ain Shams University at 1 site in Egypt.
Trial summary
The aim of this study is to compare two different methods for occlusal analysis of implant - supported prosthesis (T-scan and conventional method with articulating papers) regarding the stresses transmitted to the implants. Read more about this study
- Who is it for?
- Ages 55 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Occlusion
- What is being tested?
- T-scan and articulating paper
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Oct 2021to 30 Dec 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 55 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age range from 55-65.
- Radiographic examination should reveal bone height more than 10 mm and crestal bone width not less than 5 mm of the inter-foraminal region.
- Residual bone and mucosa should be free from any pathological signs, bony undercuts, or neoplasia.
- Adequate salivary flow.
- Adequate mouth opening.
- Adequate inter-arch space.
Who cannot join
- Systemic diseases affecting metabolism of bone e.g uncontrolled diabetes, bone diseases, hyperparathyroidism and renal disease.
- Severe blood diseases (hemophilia etc.).
- Severe vascular heart disease.
- Liver Problems.
- Cerebral infarction .
- Severe immunodeficiency.
Show all 10Show fewer
- Patients who are undergoing strong chemotherapy.
- Excessive alcohol consumption.
- Severe neuropsychiatric disease, mental disability, and narcotic drug addict
- Uncooperative patients
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of T-scan Occlusal Analysis and Adjustment vs Articulating Paper on Stresses Transmitted to Single Mandibular Implant Supported Prosthesis
The aim of this study is to compare two different methods for occlusal analysis of implant - supported prosthesis (T-scan and conventional method with articulating papers) regarding the stresses transmitted to the implants.
Read the detailed description
Four implants will be inserted, two implants in canine regions and two implants in lower second premolar regions.
After 3 months, two identical overdentures will be constructed for the patient on implants.
The occlusion of each one of the two identical prostheses will be adjusted intraorally but according to different occlusal analysis:
- Group (A) : occlusal adjustments for the overdenture will be done according to articulating paper analysis.
- Group (B) :- occlusal adjustments for the overdenture will be done according to T-scan analysis.
The two prostheses will be retained on dummy implants on acrylic cast and will be loaded under chewing simulator.
The strain developed around the dummy implants will be measured. The data will be recorded manually then will be transferred into digital form. The obtained data will be recorded, tabulated and statistically analyzed using the appropriate tests for comparison within each group.
- Conditions
- Occlusion
- Being tested
- T-scan, articulating paper
- Keywords
- t-scan, occlusal analysis, implant supported prosthesis
- Medical subject headings
- Bites and Stings
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
T-scanDevice
occlusal analysis T-scan
articulating paperOther
articulating paper occlusal analysis
| Study group | Role | What they receive |
|---|---|---|
| articulating paper occlusal adjustment | Experimental | occlusal adjustments of implant supported prosthesis according to articulating paper occlusal analysis Receives: Other: articulating paper |
| T-scan occlusal analysis | Experimental | occlusal adjustments of implant supported prosthesis according to T-scan occlusal analysis Receives: Device: T-scan |
What is being measured
The primary outcome is the main question the study is designed to answer.
stresses around implants
stresses transmitted around implants supporting the prosthesis by stain gauge
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2021
- Study start1 Oct 2021
- Primary completion30 Nov 2021
- Study completion30 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OcclusionStudies of the same condition, open and under way.
- More trials run by Ain Shams UniversityThe sponsor's other registered studies.
- 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mahmoud Alafandy, professor, Study director, oral & maxillofacial prosthodontics Faculty of Dentistry Ain-shams UniversityAhmed Osama, professor, Study director, oral & maxillofacial prosthodontics Faculty of Dentistry Ain-shams UniversityOmar ELsadat, lecturer, Study director, oral & maxillofacial prosthodontics Faculty of Dentistry Ain-shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05051878
- Sponsor's protocol ID
- OCCLUSAL EVALUATION
- Status last verified
- Jan 2023
- First submitted
- 10 Sep 2021
- Last updated
- 25 Jan 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of T-scan Occlusal Analysis and Adjustment vs Articulating Paper on Stresses Transmitted to Single Mandibular Implant Supported Prosthesis
- ClinicalTrials.gov ID
- NCT05051878
- Acronym / sponsor ID
- OCCLUSAL EVALUATION
- Conditions
- Occlusion
- Keywords
- t-scan, occlusal analysis, implant supported prosthesis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 7 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 1 Oct 2021 (actual)
- Primary completion
- 30 Nov 2021 (actual)
- Study completion
- 30 Dec 2021 (actual)
- First posted
- 21 Sep 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.
The aim of this study is to compare two different methods for occlusal analysis of implant - supported prosthesis (T-scan and conventional method with articulating papers) regarding the stresses transmitted to the implants.
Detailed description
Four implants will be inserted, two implants in canine regions and two implants in lower second premolar regions.
After 3 months, two identical overdentures will be constructed for the patient on implants.
The occlusion of each one of the two identical prostheses will be adjusted intraorally but according to different occlusal analysis:
- Group (A) : occlusal adjustments for the overdenture will be done according to articulating paper analysis.
- Group (B) :- occlusal adjustments for the overdenture will be done according to T-scan analysis.
The two prostheses will be retained on dummy implants on acrylic cast and will be loaded under chewing simulator.
The strain developed around the dummy implants will be measured. The data will be recorded manually then will be transferred into digital form. The obtained data will be recorded, tabulated and statistically analyzed using the appropriate tests for comparison within each group.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| articulating paper occlusal adjustment | Experimental | Other: articulating paperocclusal adjustments of implant supported prosthesis according to articulating paper occlusal analysis |
| T-scan occlusal analysis | Experimental | Device: T-scanocclusal adjustments of implant supported prosthesis according to T-scan occlusal analysis |
Who may qualify
- Ages
- 55 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age range from 55-65.
- Radiographic examination should reveal bone height more than 10 mm and crestal bone width not less than 5 mm of the inter-foraminal region.
- Residual bone and mucosa should be free from any pathological signs, bony undercuts, or neoplasia.
- Adequate salivary flow.
- Adequate mouth opening.
Key exclusion criteria (10 listed)
- Systemic diseases affecting metabolism of bone e.g uncontrolled diabetes, bone diseases, hyperparathyroidism and renal disease.
- Severe blood diseases (hemophilia etc.).
- Severe vascular heart disease.
- Liver Problems.
- Cerebral infarction .
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 analysis T-scan | Device | T-scan occlusal analysis |
| articulating paperarticulating paper occlusal analysis | Other | articulating paper occlusal adjustment |
Primary outcome
stresses around implants
Time frame: baseline
stresses transmitted around implants supporting the prosthesis by stain gauge
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 25 Jan 2023.
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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.
Mahmoud Alafandy, professor study director
oral & maxillofacial prosthodontics Faculty of Dentistry Ain-shams University
Ahmed Osama, professor study director
oral & maxillofacial prosthodontics Faculty of Dentistry Ain-shams University
Omar ELsadat, lecturer study director
oral & maxillofacial prosthodontics Faculty of Dentistry Ain-shams University
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 and articulating paper in people with Occlusion, 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 10 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 25 Jan 2023. 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?
stresses around implants (time frame: baseline). 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 25 Jan 2023.