Condition category
Not Applicable
Date applied
05/12/2015
Date assigned
10/12/2015
Last edited
05/05/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

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 measures

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

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

Results - basic reporting

Publication summary

2016 results in: http://www.ncbi.nlm.nih.gov/pubmed/27143970

Publication citations

Additional files

Editorial Notes

05/05/2016: Publication reference added.