Oral Stereognosis in Completely Edentulous Patient With Maxillary Tori

NCT04254848 | Completed DMC

• 1 other identifier: SEGiEC/SR/FOD/2018-19/10
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

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.

Conditions

Torus Palatinus and Torus Mandibularis

Keywords

oral stereognosis; completely edentulous

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

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.

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.

Other: oral stereognostic test

Interventions

oral stereognostic test OTHER

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.

Also known as: oral stereognostic ability

completely edentulous patients with maxillary tori; completely edentulous patients without maxillary tori

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Segi University: lead

Study Sites (1)

Faculty of Dentistry, SEGi University

Petaling Jaya, Selangor, 47410, Malaysia

Location

Related Publications (3)

• 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.

  PMID: 17441875 BACKGROUND

• 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.

  PMID: 28367901 RESULT

• 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.

  PMID: 9578225 RESULT

MeSH Terms

Conditions

Torus Palatinus and Torus Mandibularis

Study Officials

• Indumathi Sivakumar, MDS

  Senior Lecturer, Faculty of Dentistry, SEGi University, Malaysia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Supervisor and Principal investigator

Study Record Dates

• First Submitted: January 20, 2020
• First Posted: February 5, 2020
• Study Start: September 17, 2018
• Primary Completion: September 30, 2019
• Study Completion: September 16, 2020
• Last Updated: November 18, 2020

Record last verified: 2020-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Data will be available from February 2020
• 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.

Locations

MY (1)