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Clinical Trials/NCT03226990
NCT03226990CompletedNot Applicable

Detection of Pressure Areas for Elastomeric Impressions With and Without Spacer Using Novel Digital Analyzing Software and Its Correlation With Retention.A Randomized Clinical Trial.

Cairo University2 sites in 1 country40 target enrollmentStarted: June 1, 2017Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
40
Locations
2
Primary Endpoint
pressure areas

Study Overview

Brief Summary

Forty completely edentulous patients were selected and randomly distributed into two groups 20 patients each.Group I received complete dentures constructed from elastomeric impression with wax spacer,group II received complete dentures constructed from elastomeric impression with no wax spacer.then on time of denture insertion pressure areas were detected using pressure indicating paste and the denture retention was detected.The results showed less pressure areas in group I and more denture retention values than group II.

Detailed Description

This study was conducted to evaluate the significance of using wax spacer in the impression technique regarding the pressure areas and retention of the complete dentures constructed. Forty patients with edentulous maxillary arches were selected from the outpatient clinic of removable prosthodontics department, faculty of oral and dental medicine, Cairo university .The patients were randomly divided into two groups. Group I received dentures constructed from impression technique with wax spacer while group II received dentures constructed from impression technique with no spacer. On the day of denture insertion pressure areas were detected using pressure indicating paste and denture retention was measured using force gauge. The data was collected and analyzed using student's t-test.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Prevention
Masking
Double (Participant, Outcomes Assessor)

Eligibility Criteria

Ages
50 Years to 60 Years (Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • completely edentulous upper and lower arches. well to moderately developed ridges saliva of average viscosity and amount with normal temporomandibular joint

Exclusion Criteria

  • diabetic patients radiation therapy signs of inflammation, ulceration or hyperplasia neurological disorders clicking or mandibular deviation.

Outcomes

Primary Outcomes

pressure areas

Time Frame: 1month

pressure indicating paste on the fitting surface ,then the surface was captured then saved as JPEG format then Analysis was done using Image J software

Secondary Outcomes

  • denture retention(1 month)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

nancy nader elsherbini

lecturer at faculty of oral and dental medicine,cairo university

Cairo University

Study Sites (2)

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