Plain English Summary
Background and study aims
Dentures are removable false teeth that fit snugly over the gums to replace missing teeth. This study aimed to assess the effect of temperature and three denture base materials on the dimensions of complete dentures (a full set which replace all your upper or lower teeth).
Who can participate?
Men aged 60 or above
What does the study involve?
Participants are randomly divided into three groups to receive complete dentures made of three different base materials. The dimensional changes are measured at 4, 8, and 12 months at normal patient mouth temperature, after drinking hot tea and after drinking a cold drink.
What are the possible benefits and risks of participating?
Participants benefit from the provision of dentures and follow up for one year. Participants are not exposed to any hazards during the study.
Where is the study run from?
Faculty of Dentistry of Al-Azhar University (Egypt)
When is the study starting and how long is it expected to run for?
December 2014 to November 2015
Who is funding the study?
Albaha University (Saudi Arabia)
Who is the main contact?
Prof. Khalid Arafa
drkhalidarafa@yahoo.com
Trial website
Contact information
Type
Scientific
Primary contact
Prof Khalid Arafa
ORCID ID
http://orcid.org/0000-0002-3597-5073
Contact details
Dental Health Department
Faculty of Applied Medical Sciences
Albaha University
P.O. Box: 7273
Unit No.: 2 ALBAHA
65536-3047
Al-Baha
00966
Saudi Arabia
+966 (0)553 388 866
drkhalidarafa@yahoo.com
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Effect of different denture base materials and changed mouth temperature on dimensional stability of complete dentures: a quasi-experimental parallel-design study
Acronym
Study hypothesis
The denture base materials and mouth temperature affect the dimensions of complete dentures
Ethics approval
Dental Health Department of the Faculty of Applied Medical Sciences, Albaha University, December 2014
Study design
Quasi-experimental parallel-design study
Primary study design
Interventional
Secondary study design
Randomised parallel trial
Trial setting
Other
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Dentures
Intervention
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.
Intervention type
Procedure/Surgery
Phase
Drug names
Primary outcome measure
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 measures
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.
Overall trial start date
01/12/2014
Overall trial end date
24/11/2015
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Males aged 60 or above
2. Completely edentulous
3. Wearing upper and lower dentures
Participant type
Patient
Age group
Senior
Gender
Male
Target number of participants
90 patients
Participant exclusion criteria
1. Female patients
2. Under age 60
3. Partially edentulous
4. Patients with systemic disease
5. Well developed ridge
Recruitment start date
01/12/2014
Recruitment end date
01/10/2015
Locations
Countries of recruitment
Egypt
Trial participating centre
Faculty of Dentistry of Al-Azhar University
Assiut Branch
0020
Egypt
Sponsor information
Organisation
Albaha University (Saudi Arabia)
Sponsor details
Al-Baha
Al-Baha
00966
Saudi Arabia
+966 (0)553 388 866
fams1426@bu.edu.sa
Sponsor type
University/education
Website
Funders
Funder type
University/education
Funder name
Albaha University (Saudi Arabia)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
It will be published soon
Intention to publish date
01/01/2016
Participant level data
Available on request
Basic results (scientific)
Publication list
2016 results in: http://www.ncbi.nlm.nih.gov/pubmed/27143970