Torus Palatinus and Torus MandibularisNCT04254848
Oral Stereognosis in Completely Edentulous Patient With Maxillary Tori
A study testing oral stereognostic test in people with Torus Palatinus and Torus Mandibularis, run by Segi University at 1 site in Malaysia.
Trial summary
This study aimed to evaluate the oral stereognosis in completely edentulous patients with palatal tori. Oral stereognosis is tested using different test specimens in completely edentulous patients with maxillary tori and completely edentulous patients without maxillary tori. Read more about this study
- Who is it for?
- Ages 40 years and olderHealthy volunteers can take part
- Conditions the study is for
- Torus Palatinus and Torus Mandibularis
- What is being tested?
- oral stereognostic test
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteMalaysia
- Study dates
- 17 Sep 2018to 16 Sep 2020
- 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 40 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Complete edentulous patient with maxillary tori and without maxillary tori
- Complete edentulous patient who were willing give consent and eager to participate
Who cannot join
- Patients with swallow and mastication dysfunction
- Patients with cognitive disturbances
- Uncooperative patients.
- Patients with oral lesions, pathologies and Tempromandibular Joint disorders.
- Patients with systemic diseases
- Patients allergic to acrylic resin
Trial locations and contacts
1 site in 1 country.
Malaysia1 site
Faculty of Dentistry, SEGi University
Petaling Jaya, Selangor, 47410
About this study
Official title: Evaluation of Oral Stereognosis in Completely Edentulous Patient With Maxillary Tori
This study aimed to evaluate the oral stereognosis in completely edentulous patients with palatal tori. Oral stereognosis is tested using different test specimens in completely edentulous patients with maxillary tori and completely edentulous patients without maxillary tori.
Read the detailed description
Oral Stereognosis has been defined as appreciation of the form of objects that is explored intra-orally. In this study the oral stereognosis is determined by placing objects of various shapes in the patient's mouth and having the patient identify the correct form. Several studies has proved that oral stereognosis ability (OSA) can be used as a predictor for determining the ability of the patients with missing teeth to adapt to a new prosthesis placed in the patient's mouth.
Maxillary tori is a non-cancerous bony swelling found in palate and have high prevalence among Malaysian population. Whether OSA is higher or lower in patients with maxillary tori is not known.
- Conditions
- Torus Palatinus and Torus Mandibularis
- Being tested
- oral stereognostic test
- Keywords
- oral stereognosis, completely edentulous
- Medical subject headings
- Torus Palatinus and Torus Mandibularis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
oral stereognostic testOther
Also called oral stereognostic ability
Six test pieces were selected from the 20 shapes of test pieces from National Institute of Dental Research. The test pieces comprises of 6 shaped forms which include circle, plus, square, rectangular, triangle and toroid shaped. A 2mm stainless steel wire was bent forming the test piece shape following the standard dimensions (13mm length and 2mm thickness)as described by National Institute of Dental Research to serve as the test pieces mould. Using the six test piece moulds, light cured acrylic resin test samples were fabricated. The test samples were trimmed and polished to meet the standardized measurements. A total of 240 test sample (6 samples for each patient) for 20 completely edentulous patients with maxillary tori and 20 completely edentulous patients without tori were made for the study. The test pieces were attached to dental floss to prevent any accidentally aspiration during the study.
| Study group | Role | What they receive |
|---|---|---|
| completely edentulous patients with maxillary tori | Experimental | 20 completely edentulous patients with maxillary tori will be recruited for the study. The oral stereognosis will be evaluated by oral stereognostic test which employs manipulation and identification 6 different test pieces when placed in the patients mouth. Receives: Other: oral stereognostic test |
| completely edentulous patients without maxillary tori | Active comparator | 20 completely edentulous patients without maxillary tori will serve as control group for the study. The oral stereognosis will be evaluated by oral stereognostic test which employs manipulation and identification 6 different test pieces when placed in the patients mouth. Receives: Other: oral stereognostic test |
What is being measured
The primary outcome is the main question the study is designed to answer.
changes in the oral stereognosis
Oral stereognosis test will be performed using test pieces will be placed intraorally and patients will be instructed to identify the shape of test pieces with their tongue and palate. A visual representation chart of all 6 shaped forms will be provided to patient for identification purpose. Patients will be asked to identify the correct shape form by pointing out on the corresponding shape form on the chart. The 6 test pieces will be presented randomly to the patients and correct answer will not be informed to the patients during the OSA. The duration time for recognition of each shaped form for each patient will be noted and answers will be recorded on an OSA evaluation form. A correct answer will recorded as one point and incorrect answer is zero point. A full 6 points will be scored if all answers were correct. The response time and the OSA scores will be recorded.
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2020
- Study start17 Sep 2018
- Primary completion30 Sep 2019
- Study completion16 Sep 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Torus Palatinus and Torus MandibularisStudies 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
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Segi University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Indumathi Sivakumar, Segi University
- Investigators
- Indumathi Sivakumar, MDS, Principal investigator, Senior Lecturer, Faculty of Dentistry, SEGi University, Malaysia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04254848
- Sponsor's protocol ID
- SEGiEC/SR/FOD/2018-19/10
- Status last verified
- Nov 2020
- First submitted
- 20 Jan 2020
- Last updated
- 18 Nov 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data pertaining to oral stereognosis scores obtained by the participants and the response time duration for completing the test would be shared.
Publications
Ikebe K, Amemiya M, Morii K, Matsuda K, Furuya-Yoshinaka M, Nokubi T. Comparison of oral stereognosis in relation to age and the use of complete dentures. J Oral Rehabil. 2007 May;34(5):345-50. doi: 10.1111/j.1365-2842.2007.01687.x.
PubMed 17441875Park JH. Changes in oral stereognosis of healthy adults by age. J Oral Sci. 2017;59(1):71-76. doi: 10.2334/josnusd.16-0366.
PubMed 28367901Mantecchini G, Bassi F, Pera P, Preti G. Oral stereognosis in edentulous subjects rehabilitated with complete removable dentures. J Oral Rehabil. 1998 Mar;25(3):185-9. doi: 10.1046/j.1365-2842.1998.00221.x.
PubMed 9578225
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Oral Stereognosis in Completely Edentulous Patient With Maxillary Tori
- ClinicalTrials.gov ID
- NCT04254848
- Acronym / sponsor ID
- SEGiEC/SR/FOD/2018-19/10
- Conditions
- Torus Palatinus and Torus Mandibularis
- Keywords
- oral stereognosis, completely edentulous
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Segi UniversityUniversity, hospital or other
- Study start
- 17 Sep 2018 (actual)
- Primary completion
- 30 Sep 2019 (actual)
- Study completion
- 16 Sep 2020 (actual)
- First posted
- 5 Feb 2020 (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.
This study aimed to evaluate the oral stereognosis in completely edentulous patients with palatal tori. Oral stereognosis is tested using different test specimens in completely edentulous patients with maxillary tori and completely edentulous patients without maxillary tori.
Detailed description
Oral Stereognosis has been defined as appreciation of the form of objects that is explored intra-orally. In this study the oral stereognosis is determined by placing objects of various shapes in the patient's mouth and having the patient identify the correct form. Several studies has proved that oral stereognosis ability (OSA) can be used as a predictor for determining the ability of the patients with missing teeth to adapt to a new prosthesis placed in the patient's mouth.
Maxillary tori is a non-cancerous bony swelling found in palate and have high prevalence among Malaysian population. Whether OSA is higher or lower in patients with maxillary tori is not known.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| completely edentulous patients with maxillary tori | Experimental | Other: oral stereognostic test20 completely edentulous patients with maxillary tori will be recruited for the study. The oral stereognosis will be evaluated by oral stereognostic test which employs manipulation and identification 6 different test pieces when placed in the patients mouth. |
| completely edentulous patients without maxillary tori | Active comparator | Other: oral stereognostic test20 completely edentulous patients without maxillary tori will serve as control group for the study. The oral stereognosis will be evaluated by oral stereognostic test which employs manipulation and identification 6 different test pieces when placed in the patients mouth. |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Complete edentulous patient with maxillary tori and without maxillary tori
- Complete edentulous patient who were willing give consent and eager to participate
Key exclusion criteria (6 listed)
- Patients with swallow and mastication dysfunction
- Patients with cognitive disturbances
- Uncooperative patients.
- Patients with oral lesions, pathologies and Tempromandibular Joint disorders.
- Patients with systemic diseases
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 |
|---|---|---|
| oral stereognostic testAlso: oral stereognostic abilitySix test pieces were selected from the 20 shapes of test pieces from National Institute of Dental Research. The test pieces comprises of 6 shaped forms which include circle, plus, square, rectangular, triangle and toroid shaped. A 2mm stainless steel wire was bent forming the test piece shape following the standard dimensions (13mm length and 2mm thickness)as described by National Institute of Dental Research to serve as the test pieces mould. Using the six test piece moulds, light cured acrylic resin test samples were fabricated. The test samples were trimmed and polished to meet the standardized measurements. A total of 240 test sample (6 samples for each patient) for 20 completely edentulous patients with maxillary tori and 20 completely edentulous patients without tori were made for the study. The test pieces were attached to dental floss to prevent any accidentally aspiration during the study. | Other | completely edentulous patients with maxillary tori, completely edentulous patients without maxillary tori |
Primary outcome
changes in the oral stereognosis
Time frame: through study completion, an average of 1 year
Oral stereognosis test will be performed using test pieces will be placed intraorally and patients will be instructed to identify the shape of test pieces with their tongue and palate. A visual representation chart of all 6 shaped forms will be provided to patient for identification purpose. Patients will be asked to identify the correct shape form by pointing out on the corresponding shape form on the chart. The 6 test pieces will be presented randomly to the patients and correct answer will not be informed to the patients during the OSA. The duration time for recognition of each shaped form for each patient will be noted and answers will be recorded on an OSA evaluation form. A correct answer will recorded as one point and incorrect answer is zero point. A full 6 points will be scored if all answers were correct. The response time and the OSA scores will be recorded.
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 18 Nov 2020.
- Background: PubMed 17441875Ikebe K, Amemiya M, Morii K, Matsuda K, Furuya-Yoshinaka M, Nokubi T. Comparison of oral stereognosis in relation to age and the use of complete dentures. J Oral Rehabil. 2007 May;34(5):345-50. doi: 10.1111/j.1365-2842.2007.01687.x.
- Results publication: PubMed 28367901Park JH. Changes in oral stereognosis of healthy adults by age. J Oral Sci. 2017;59(1):71-76. doi: 10.2334/josnusd.16-0366.
- Results publication: PubMed 9578225Mantecchini G, Bassi F, Pera P, Preti G. Oral stereognosis in edentulous subjects rehabilitated with complete removable dentures. J Oral Rehabil. 1998 Mar;25(3):185-9. doi: 10.1046/j.1365-2842.1998.00221.x.
- Individual participant dataSharing planned: Yes. The data pertaining to oral stereognosis scores obtained by the participants and the response time duration for completing the test would be shared.
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.
Indumathi Sivakumar, MDS principal investigator
Senior Lecturer, Faculty of Dentistry, SEGi University, Malaysia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing oral stereognostic test in people with Torus Palatinus and Torus Mandibularis, run by Segi University at 1 site in Malaysia.
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 2 inclusion and 6 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 18 Nov 2020. 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 Malaysia. 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?
changes in the oral stereognosis (time frame: through study completion, an average of 1 year). 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 NCT04254848, which also lists 3 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 18 Nov 2020.