Plain English Summary
Background and study aims
False teeth (dentures) are mainly made from two types of material: acrylic resin and porcelain. Wearing complete dentures may cause temporomandibular disorder (TMD). TMD is a problem affecting the chewing muscles and the joints between the jaw and the skull, which can cause pain and difficulties eating. This study aims to assess the role of clinical wear in the incidence of TMD among patients with acrylic resin and porcelain complete dentures.
Who can participate?
Patients requiring complete dentures.
What does the study involve?
Participants are randomly allocated into two groups. One group receives upper and lower complete dentures with teeth made of acrylic resin. The other group receives upper and lower complete dentures with teeth made of porcelain. Both groups are followed up after 6, 12, 18 and 24 months for assessment of clinical wear and incidence of TMD.
What are the possible benefits and risks of participating?
Participants will benefit from receiving dentures and continuous clinical follow up. The results of the study will improve our knowledge of the causes of TMD and provide a basis for developing a new artificial teeth material.
Where is the study run from?
University of Khartoum (Sudan)
When is the study starting and how long is it expected to run for?
January 2014 to January 2016
Who is funding the study?
Albaha University (Saudi Arabia)
Who is the main contact?
Prof. Khalid Arafa
Prof Khalid Arafa
Faculty of Applied Medical Sciences
+966 (0)553 388 866
Dr Yahya Ahmed
Effect of clinical wear in incidence of temporomandibular disorders among complete denture patients: a randomized clinical trial
Clinical wear of denture teeth is usually expected in patients after years of denture use. Posterior teeth seemed to be more affected by food abrasion. Development of facets in the anterior teeth due to attrition (tooth to tooth contact) usually occurs. A positive relationship has been found between the duration of complete denture wearing and the incidence of temporomandibular disorder (TMD).
The aim of this study is to determine the effects of clinical wear on the incidence of temporomandibular disorders among complete denture patients.
Technical and ethical committee at University of Khartoum, 01/01/2014
Randomized clinical trial, parallel arm design
Primary study design
Secondary study design
Randomised parallel trial
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
The patients who agreed to participate in this study were assigned randomly using random table numbers into two groups:
Group 1 (intervention group) patients received upper and lower complete dentures with teeth made of heat cure acrylic resin (Meliodent- Bayer dental, Germany batch no 54105L-2).
Group 2 (control group) patients received upper and lower complete dentures with teeth made of porcelain (dent supply, Germany batch no 43105L-1).
The patients were followed up for two years at 6, 12, 18 and 24 months for assessment of clinical wear and incidence of TMD.
Primary outcome measure
Clinical wear measured using computerized imaging measuring system at 6, 12, 18 and 24 months
Secondary outcome measures
Incidence of TMD measured using Helkimo clinical dysfunction index at 6, 12, 18 and 24 months
Overall trial start date
Overall trial end date
Reason abandoned (if study stopped)
Participant inclusion criteria
Edentulous patients in need of complete dentures
Target number of participants
Participant exclusion criteria
1. Patients with severe malocclusion
2. Patients with systematic diseases affecting the temporomandibular joint like generalized fibromyaligia, rheumatoid arthritis or post-traumatic stress disorder
Recruitment start date
Recruitment end date
Countries of recruitment
Trial participating centre
Faculty of Dentistry, University of Khartoum
Albaha University (Saudi Arabia)
Funding Body Type
Funding Body Subtype
Results and Publications
Publication and dissemination plan
The study is currently under process of publication in one of the dentistry international journals. It will include results and main findings from this study. The published article will be announced for all dentistry specialist and students.
Intention to publish date
Participant level data
Available on request
Basic results (scientific)