Clinical wear and incidence of temporomandibular disorders among complete denture patients

ISRCTN	ISRCTN27154312
DOI	https://doi.org/10.1186/ISRCTN27154312
Secondary identifying numbers	N/A

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

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

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

Prof Khalid Arafa
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
Email	drkhalidarafa@yahoo.com

Dr Yahya Ahmed
Public

Khartoum
Khartoum
00249
Sudan

Study information

Study design	Randomized clinical trial, parallel arm design
Primary study design	Interventional
Secondary study design	Randomised parallel trial
Study setting(s)	Hospital
Study type	Treatment
Participant information sheet	Not available in web format, please use the contact details below to request a patient 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	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 study start date	01/01/2014
Completion date	05/01/2016

Eligibility

Participant type(s)	Patient
Age group	Senior
Sex	Both
Target number of participants	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

Faculty of Dentistry, University of Khartoum

Khartoum
00249
Sudan

Sponsor information

Albaha University (Saudi Arabia)
Government

Al-Baha
Al-Baha
00966
Saudi Arabia

"ROR"	https://ror.org/0403jak37

Funders

Funder type

University/education

Albaha University (Saudi Arabia)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	Yes
IPD sharing plan summary	Available on request
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.
IPD sharing plan