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 |
| Protocol serial number | N/A |
| Sponsor | Albaha University (Saudi Arabia) |
| Funder | Albaha University (Saudi Arabia) |
- 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
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
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 ID |
0000-0002-3597-5073 |
|---|---|
| Phone | +966 (0)553 388 866 |
| drkhalidarafa@yahoo.com |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Quasi-experimental parallel-design study |
| Secondary study design | Randomised parallel trial |
| Study type | Participant information sheet |
| Scientific title | Effect of different denture base materials and changed mouth temperature on dimensional stability of complete dentures: a quasi-experimental parallel-design study |
| Study objectives | The 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) studied | 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 |
| Primary outcome measure(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. |
| Key secondary outcome measure(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. |
| Completion date | 24/11/2015 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Senior |
| Sex | Male |
| Target sample size at registration | 90 |
| Key inclusion criteria | 1. Males aged 60 or above 2. Completely edentulous 3. Wearing upper and lower dentures |
| Key exclusion criteria | 1. Female patients 2. Under age 60 3. Partially edentulous 4. Patients with systemic disease 5. Well developed ridge |
| Date of first enrolment | 01/12/2014 |
| Date of final enrolment | 01/10/2015 |
Locations
Countries of recruitment
- Egypt
Study participating centre
0020
Egypt
Results and Publications
| Individual participant data (IPD) Intention to share | Yes |
|---|---|
| IPD sharing plan summary | Available on request |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/01/2016 | Yes | No | |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
05/05/2016: Publication reference added.
