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Oral Stereognosis in Completely Edentulous Patient With Maxillary Tori

Primary Purpose

Torus Palatinus and Torus Mandibularis

Status
Completed
Phase
Not Applicable
Locations
Malaysia
Study Type
Interventional
Intervention
oral stereognostic test
Sponsored by
Segi University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Torus Palatinus and Torus Mandibularis focused on measuring oral stereognosis, completely edentulous

Eligibility Criteria

40 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Complete edentulous patient with maxillary tori and without maxillary tori
  • Complete edentulous patient who were willing give consent and eager to participate

Exclusion Criteria:

  • 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

Sites / Locations

  • Faculty of Dentistry, SEGi University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

completely edentulous patients with maxillary tori

completely edentulous patients without maxillary tori

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
January 20, 2020
Last Updated
November 16, 2020
Sponsor
Segi University
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1. Study Identification

Unique Protocol Identification Number
NCT04254848
Brief Title
Oral Stereognosis in Completely Edentulous Patient With Maxillary Tori
Official Title
Evaluation of Oral Stereognosis in Completely Edentulous Patient With Maxillary Tori
Study Type
Interventional

2. Study Status

Record Verification Date
November 2020
Overall Recruitment Status
Completed
Study Start Date
September 17, 2018 (Actual)
Primary Completion Date
September 30, 2019 (Actual)
Study Completion Date
September 16, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Segi University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Torus Palatinus and Torus Mandibularis
Keywords
oral stereognosis, completely edentulous

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
34 (Actual)

8. Arms, Groups, and Interventions

Arm Title
completely edentulous patients with maxillary tori
Arm Type
Experimental
Arm Description
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.
Arm Title
completely edentulous patients without maxillary tori
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
oral stereognostic test
Other Intervention Name(s)
oral stereognostic ability
Intervention Description
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.
Primary Outcome Measure Information:
Title
changes in the oral stereognosis
Description
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.
Time Frame
through study completion, an average of 1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Complete edentulous patient with maxillary tori and without maxillary tori Complete edentulous patient who were willing give consent and eager to participate Exclusion Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Indumathi Sivakumar, MDS
Organizational Affiliation
Senior Lecturer, Faculty of Dentistry, SEGi University, Malaysia
Official's Role
Principal Investigator
Facility Information:
Facility Name
Faculty of Dentistry, SEGi University
City
Petaling Jaya
State/Province
Selangor
ZIP/Postal Code
47410
Country
Malaysia

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
The data pertaining to oral stereognosis scores obtained by the participants and the response time duration for completing the test would be shared.
IPD Sharing Time Frame
Data will be available from February 2020
IPD Sharing Access Criteria
Researchers in this field of study who request data for multicentric study comparison. Data access request will be reviewed by a panel of reviewers.
Citations:
PubMed Identifier
17441875
Citation
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.
Results Reference
background
PubMed Identifier
28367901
Citation
Park 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 Reference
result
PubMed Identifier
9578225
Citation
Mantecchini 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.
Results Reference
result

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Oral Stereognosis in Completely Edentulous Patient With Maxillary Tori

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