Oral Stereognosis in Completely Edentulous Patient With Maxillary Tori

Not Applicable

Completed

• Conditions: Torus Palatinus and Torus Mandibularis
• Interventions: Other: oral stereognostic test

• Registration Number: NCT04254848
• Lead Sponsor: Segi University

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.

Study Timeline

• Study Start: 2018-09-17
• Primary Completion: 2019-09-30
• Study First Submitted: 2020-01-20
• Study First Submitted QC: 2020-02-02
• Study First Posted: 2020-02-05
• Study Completion: 2020-09-16
• Status Verified: 2020-11
• Last Update Submitted: 2020-11-16
• Last Update Posted: 2020-11-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 34

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
completely edentulous patients with maxillary tori	oral stereognostic test	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.
completely edentulous patients without maxillary tori	oral stereognostic test	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.

Primary Outcome Measures

Name	Time	Method
changes in the oral stereognosis	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.

Trial Locations

Locations (1)

Faculty of Dentistry, SEGi University; 🇲🇾 Petaling Jaya, Selangor, Malaysia