Condition category
Oral Health
Date applied
21/02/2016
Date assigned
05/03/2016
Last edited
04/03/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

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
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

Albaha University
Faculty of Applied Medical Sciences
Al-Baha
00966
Saudi Arabia
+966 (0)553 388 866
drkhalidarafa@yahoo.com

Type

Public

Additional contact

Dr Yahya Ahmed

ORCID ID

Contact details

Khartoum
Khartoum
00249
Sudan

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Effect of clinical wear in incidence of temporomandibular disorders among complete denture patients: a randomized clinical trial

Acronym

Study hypothesis

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

Technical and ethical committee at University of Khartoum, 01/01/2014

Study design

Randomized clinical trial, parallel arm design

Primary study design

Interventional

Secondary study design

Randomised parallel trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

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

Phase

Drug names

Primary outcome measures

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

01/01/2014

Overall trial end date

05/01/2016

Reason abandoned

Eligibility

Participant inclusion criteria

Edentulous patients in need of complete dentures

Participant type

Patient

Age group

Senior

Gender

Both

Target number of participants

64

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

15/01/2014

Recruitment end date

01/12/2015

Locations

Countries of recruitment

Sudan

Trial participating centre

Faculty of Dentistry, University of Khartoum
Khartoum
00249
Sudan

Sponsor information

Organisation

Albaha University (Saudi Arabia)

Sponsor details

Al-Baha
Al-Baha
00966
Saudi Arabia

Sponsor type

Government

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

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

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes