Clinical trial NCT03226990: 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
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Free Completely Edentulous Patients
Keywords: pressure area
polyether elastomeric impression
wax spacer
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2017-07-24
Enrollment: 40
Sex: ALL
Minimum age (years): 50
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The measurements are done on the day of denture insertion with no follow up timing intervals
Primary purpose: PREVENTION

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.

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.

Primary outcomes:
measure: pressure areas
timeFrame: 1month
Secondary outcomes:
measure: denture retention
timeFrame: 1 month
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Nancy Nader Elsherbini
Study officials:
References:
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.
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.
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.