Effect of different denture base materials and changed mouth temperature on dimensional stability of complete dentures

ISRCTN ISRCTN94238244
DOI https://doi.org/10.1186/ISRCTN94238244
Secondary identifying numbers N/A
Submission date
05/12/2015
Registration date
10/12/2015
Last edited
05/05/2016
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Other
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

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

Contact information

Prof Khalid Arafa
Scientific

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

ORCiD logoORCID ID 0000-0002-3597-5073
Phone +966 (0)553 388 866
Email drkhalidarafa@yahoo.com

Study information

Study designQuasi-experimental parallel-design study
Primary study designInterventional
Secondary study designRandomised parallel trial
Study setting(s)Other
Study typeTreatment
Participant information sheet Not available in web format, please use the contact details below to request a patient information sheet
Scientific titleEffect of different denture base materials and changed mouth temperature on dimensional stability of complete dentures: a quasi-experimental parallel-design study
Study objectivesThe denture base materials and mouth temperature affect the dimensions of complete dentures
Ethics approval(s)Dental Health Department of the Faculty of Applied Medical Sciences, Albaha University, December 2014
Health condition(s) or problem(s) studiedDentures
InterventionThe 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 typeProcedure/Surgery
Primary outcome measureDemographic 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 measuresThe 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 study start date01/12/2014
Completion date24/11/2015

Eligibility

Participant type(s)Patient
Age groupSenior
SexMale
Target number of participants90 patients
Key inclusion criteria1. Males aged 60 or above
2. Completely edentulous
3. Wearing upper and lower dentures
Key exclusion criteria1. Female patients
2. Under age 60
3. Partially edentulous
4. Patients with systemic disease
5. Well developed ridge
Date of first enrolment01/12/2014
Date of final enrolment01/10/2015

Locations

Countries of recruitment

  • Egypt

Study participating centre

Faculty of Dentistry of Al-Azhar University
Assiut Branch
0020
Egypt

Sponsor information

Albaha University (Saudi Arabia)
University/education

Al-Baha
Al-Baha
00966
Saudi Arabia

Phone +966 (0)553 388 866
Email fams1426@bu.edu.sa
ROR logo "ROR" https://ror.org/0403jak37

Funders

Funder type

University/education

Albaha University (Saudi Arabia)

No information available

Results and Publications

Intention to publish date01/01/2016
Individual participant data (IPD) Intention to shareYes
IPD sharing plan summaryAvailable on request
Publication and dissemination planIt will be published soon
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article results 01/01/2016 Yes No

Editorial Notes

05/05/2016: Publication reference added.