Clinical wear and incidence of temporomandibular disorders among complete denture patients
| ISRCTN | ISRCTN27154312 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN27154312 |
| Protocol serial number | N/A |
| Sponsor | Albaha University (Saudi Arabia) |
| Funder | Albaha University (Saudi Arabia) |
- Submission date
- 21/02/2016
- Registration date
- 05/03/2016
- Last edited
- 04/03/2016
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Oral Health
Plain English summary of protocol
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
drkhalidarafa@yahoo.com
Contact information
Scientific
Albaha University
Faculty of Applied Medical Sciences
Al-Baha
00966
Saudi Arabia
 ORCID ID |
0000-0002-3597-5073 |
|---|---|
| Phone | +966 (0)553 388 866 |
| drkhalidarafa@yahoo.com |
Public
Khartoum
Khartoum
00249
Sudan
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomized clinical trial, parallel arm design |
| Secondary study design | Randomised parallel trial |
| Study type | Participant information sheet |
| Scientific title | Effect of clinical wear in incidence of temporomandibular disorders among complete denture patients: a randomized clinical trial |
| Study objectives | 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. |
| Ethics approval(s) | Technical and ethical committee at University of Khartoum, 01/01/2014 |
| Health condition(s) or problem(s) studied | Temporomandibular disorder |
| Intervention | 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. |
| Intervention type | Procedure/Surgery |
| Primary outcome measure(s) |
Clinical wear measured using computerized imaging measuring system at 6, 12, 18 and 24 months |
| Key secondary outcome measure(s) |
Incidence of TMD measured using Helkimo clinical dysfunction index at 6, 12, 18 and 24 months |
| Completion date | 05/01/2016 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Senior |
| Sex | All |
| Target sample size at registration | 64 |
| Key inclusion criteria | Edentulous patients in need of complete dentures |
| Key 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 |
| Date of first enrolment | 15/01/2014 |
| Date of final enrolment | 01/12/2015 |
Locations
Countries of recruitment
- Sudan
Study participating centre
00249
Sudan
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? |
|---|---|---|---|---|---|
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
