Oral Stereognosis in Completely Edentulous Patient With Maxillary Tori

Study Overview
=================
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.

Official Title
-----------------
Evaluation of Oral Stereognosis in Completely Edentulous Patient With Maxillary Tori

Conditions
-----------------
Torus Palatinus and Torus Mandibularis

Intervention / Treatment
-----------------
* Other: oral stereognostic test


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 40 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: completely edentulous patients with maxillary tori<br>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<br>* 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.<br>* Other names: oral stereognostic ability;|
| Active Comparator: completely edentulous patients without maxillary tori<br>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<br>* 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.<br>* Other names: oral stereognostic ability;|

What is the study measuring?
-----------------
Primary Outcome Measures

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

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
oral stereognosis, completely edentulous