Detection of Pressure Areas for Two Elastomeric Impressions

Diabetes Free Completely Edentulous Patients Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03226990
• Other study ID #: prosthesis87-2017
• Status: Completed
• Phase: N/A
• First received: July 17, 2017
• Last updated: July 21, 2017
• Start date: June 1, 2017
• Est. completion date: July 1, 2017

Study information

• Verified date: July 2017
• Source: Cairo University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: July 1, 2017
• Est. primary completion date: July 1, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Diabetes Free Completely Edentulous Patients

Intervention

Other:
• impression technique
impression technique with and without wax spacer

Locations

Country	Name	City	State
Egypt	Nancy Nader Elsherbini	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

References & Publications (3)

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. Epub 2007 Dec 5. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	1month
Secondary	denture retention	using force gauge to give retentive values in Newtons	1 month