Back to resultsDetection of Pressure Areas for Two Elastomeric Impressions
Primary Purpose
Diabetes Free Completely Edentulous Patients
Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
impression technique
Sponsored by
About this trial
This is an interventional prevention trial for Diabetes Free Completely Edentulous Patients focused on measuring pressure area, polyether elastomeric impression, wax spacer
Eligibility Criteria
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.
Sites / Locations
- Nancy Nader Elsherbini
Outcomes
Primary Outcome Measures
pressure areas
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 Outcome Measures
denture retention
using force gauge to give retentive values in Newtons
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03226990
Brief Title
Detection of Pressure Areas for Two Elastomeric Impressions
Official Title
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.
Study Type
Interventional
2. Study Status
Record Verification Date
July 2017
Overall Recruitment Status
Completed
Study Start Date
June 1, 2017 (Actual)
Primary Completion Date
July 1, 2017 (Actual)
Study Completion Date
July 1, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Free Completely Edentulous Patients
Keywords
pressure area, polyether elastomeric impression, wax spacer
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
The measurements are done on the day of denture insertion with no follow up timing intervals
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Other
Intervention Name(s)
impression technique
Intervention Description
impression technique with and without wax spacer
Primary Outcome Measure Information:
Title
pressure areas
Description
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
Time Frame
1month
Secondary Outcome Measure Information:
Title
denture retention
Description
using force gauge to give retentive values in Newtons
Time Frame
1 month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Nancy Nader Elsherbini
City
Cairo
ZIP/Postal Code
11867
Country
Egypt
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
12237795
Citation
Masri R, Driscoll CF, Burkhardt J, Von Fraunhofer A, Romberg E. Pressure generated on a simulated oral analog by impression materials in custom trays of different designs. J Prosthodont. 2002 Sep;11(3):155-60.
Results Reference
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PubMed Identifier
25831114
Citation
Wang CW, Shao Q, Sun HQ, Mao MY, Zhang XW, Gong Q, Xiao GN. Influence of inner circular sealing area impression method on the retention of complete dentures. Braz Dent J. 2015 Mar-Apr;26(2):198-202. doi: 10.1590/0103-6440201300383. Epub 2015 Apr 1.
Results Reference
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PubMed Identifier
18053059
Citation
Al-Ahmar AO, Lynch CD, Locke M, Youngson CC. Quality of master impressions and related materials for fabrication of complete dentures in the UK. J Oral Rehabil. 2008 Feb;35(2):111-5. doi: 10.1111/j.1365-2842.2007.01796.x. Epub 2007 Dec 5.
Results Reference
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Detection of Pressure Areas for Two Elastomeric Impressions
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