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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ISRCTN
Last refreshed on: 17 October 2016
Main ID:  ISRCTN94238244
Date of registration: 10/12/2015
Prospective Registration: No
Primary sponsor: Albaha University (Saudi Arabia)
Public title: Effect of different denture base materials and changed mouth temperature on dimensional stability of complete dentures
Scientific title: Effect of different denture base materials and changed mouth temperature on dimensional stability of complete dentures: a quasi-experimental parallel-design study
Date of first enrolment: 01/12/2014
Target sample size: 90
Recruitment status: Completed
URL:  http://isrctn.com/ISRCTN94238244
Study type:  Interventional
Study design:  Quasi-experimental parallel-design study (Treatment)  
Phase: 
Countries of recruitment
Egypt
Contacts
Name: Khalid    Arafa
Address:  Dental Health Department Faculty of Applied Medical Sciences Albaha University P.O. Box: 7273 Unit No.: 2 ALBAHA 65536-3047 00966 Al-Baha Saudi Arabia
Telephone: +966 (0)553 388 866
Email: drkhalidarafa@yahoo.com
Affiliation: 
Name:    
Address: 
Telephone:
Email:
Affiliation: 
Key inclusion & exclusion criteria
Inclusion criteria: 1. Males aged 60 or above
2. Completely edentulous
3. Wearing upper and lower dentures

Exclusion criteria: 1. Female patients
2. Under age 60
3. Partially edentulous
4. Patients with systemic disease
5. Well developed ridge


Age minimum:
Age maximum:
Gender: Male
Health Condition(s) or Problem(s) studied
Dentures
Not Applicable
Intervention(s)
The three groups received complete dentures fabricated by one of the following base materials (heat cure acrylic resin, soft cure acrylic resin, cobalt chrome metallic).

The first group received complete denture fabricated by heat cure acrylic resin (Meliodent-Bayer dental, Germany batch no 54105L-2) curing cycles in acrylic furnace, at 165°F for 9 (acrylic furnace Bego sommer, Germany batch 226-433). The second group received complete denture fabricated by soft cure acrylic resin (vertex thermo sense rigid batch noxu373802 USA). The third group received complete denture fabricated by cobalt chrome metallic denture base (Bego metal denture base Germany batch 233-42), using the burnout furnace controlled electronically at (950-1200)c fasting furnace (bego Germany batch 239270).

For all the patients, the primary impression was taken by alginate then taking the second impression by rubber base (coltene swiss quality for dentistry batch 4160). In the third visit the jaw relationship was taken, in the fourth visit a try in the waxed denture (Cavex, Holland batch Z.A 990.01) was done, followed by fabrication of the denture in the dental lab. During the denture fabrication two different points were prepared in the fitting surface of the waxed denture (first point in the incisive papilla, second point in mid line of the post dam). After the procedures were finished the point shack in the fitting surface measurement by dial caliper step measurement.
Primary Outcome(s)
Demographic data and denture dimensions. All groups with complete dentures were evaluated after 4 months, 8 months and lastly after 12 months, and evaluated at normal patient mouth temperature, after drinking hot tea at 45c, and after drinking a cold drink at 5c.
Secondary Outcome(s)
The accuracy of denture dimensions measurement. All groups with complete dentures were evaluated after 4 months, 8 months and lastly after 12 months, and evaluated at normal patient mouth temperature, after drinking hot tea at 45c, and after drinking a cold drink at 5c.
Secondary ID(s)
N/A
Source(s) of Monetary Support
Albaha University (Saudi Arabia)
Secondary Sponsor(s)
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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