Oral Stereognosis in Completely Edentulous Patient With Maxillary Tori

November 16, 2020 updated by: Indumathi Sivakumar, Segi University

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

34

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Malaysia
    • Selangor
      • Petaling Jaya, Selangor, Malaysia, 47410
        • Faculty of Dentistry, SEGi University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: completely edentulous patients with maxillary tori
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.
Other: oral stereognostic test
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.
Other Names:
  • oral stereognostic ability
Active Comparator: completely edentulous patients without maxillary tori
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.
Other: oral stereognostic test
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.
Other Names:
  • oral stereognostic ability

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
through study completion, an average of 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Segi University

Investigators

  • Principal Investigator: Indumathi Sivakumar, MDS, Senior Lecturer, Faculty of Dentistry, SEGi University, Malaysia

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 17, 2018

Primary Completion (Actual)

September 30, 2019

Study Completion (Actual)

September 16, 2020

Study Registration Dates

First Submitted

January 20, 2020

First Submitted That Met QC Criteria

February 2, 2020

First Posted (Actual)

February 5, 2020

Study Record Updates

Last Update Posted (Actual)

November 18, 2020

Last Update Submitted That Met QC Criteria

November 16, 2020

Last Verified

November 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SEGiEC/SR/FOD/2018-19/10

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD 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.

IPD Sharing Supporting Information Type

  • Study Protocol

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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