Effect of diabetes mellitus on root canal disease

ISRCTN	ISRCTN10910963
DOI	https://doi.org/10.1186/ISRCTN10910963
Secondary identifying numbers	201/5/2015

Submission date: 12/06/2016
Registration date: 15/06/2016
Last edited: 15/06/2016

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
Apical periodontitis (AP) is an acute or chronic dental condition where there is inflammation around the apex (tip) of a tooth root caused by a bacterial infection of the pulp of the tooth (soft tissue in the centre of the tooth). Research suggests that the microbes that cause the condition are quite similar to those that cause periodontal (gum) disease. Tooth pulp from patients with diabetes mellitis (DM) may suffer from a poor than usual blood supply and a poor than usual immune response. This means that DM patients are at increased risk of developing a pulp infection, pulp necrosis (pulp death) and toothache. A few studies have suggested that DM patients may be more prone to develop AP. However, findings have not yet confirmed if having DM affects success rate of root canal treatment compared to healthy people without DM. Furthermore, few studies have examined the effect of glycaemic control (control of blood sugar levels) on the prevalence of AP.The aim of this study is to look at the number of DM patients with AP compared to healthy non-diabetic people and examine the effect of glycaemic control on AP.

Who can participate?
Adult DM patients attending diabetes clinics at King Hussein Medical Centre and non-diabetic volunteers matched for age, gender and social class.

What does the study involve?
All participants are examined to see whether they suffer from AP using mouth panoramic x-rays. It is a one-time test and there is no follow-up.

What are the possible benefits and risks of participating?
Not provided at time of registration

Where is the study run from?
King Hussein Medical Center, Amman (Jordan)

When is the study starting and how long is it expected to run for?
November 2914 to September 2015

Who is funding the study?
King Hussein Medical Center, Amman (Jordan)

Who is the main contact?
Dr Leena Smadi
alsomadi@yahoo.com

Contact information

Dr Leena Smadi
Public

PO Box 830453
Amman
111803
Jordan

Phone	00962797197875
Email	alsomadi@yahoo.com

Study information

Study design	Comparative cross sectional survey
Primary study design	Observational
Secondary study design	Cross sectional study
Study setting(s)	Hospital
Study type	Screening
Participant information sheet	No participant information sheet available
Scientific title	Apical periodontitis and endodontic treatment in patients with type 2 diabetes mellitus: comparative cross sectional survey
Study objectives	The aim of this study was to investigate the prevalence of apical periodontitis (AP) in diabetic patients compared with matched non-diabetic patients and also to examine the effect of glycaemic control on the incidence of AP.
Ethics approval(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	Apical periodontitis
Intervention	There are two groups of participants taking part in this trial; diabetic participants and non-diabetic control participants. All participants from both groups are evaluated for apical periodontitis using mouth panoramic x-rays. It is a one test setup with no follow-up.
Intervention type	Other
Primary outcome measure	Peri-apical status of tested teeth as an indication of periapical periodontitis, assessed via panoramic radiographs
Secondary outcome measures	Presence of endodontic treatment of tested teeth and success of treatment as assessed by the peri-apical index (PAI) score
Overall study start date	01/11/2014
Completion date	30/09/2015

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Both
Target number of participants	300
Key inclusion criteria	1. Diabetic patients attending diabetes clinics at King Hussein Medical Centre 2. Age, gender and social class-matched non-diabetic volunteers and participants who attended a family medicine clinic at the same hospital
Key exclusion criteria	Participants that do not fulfill the inclusion criteria
Date of first enrolment	01/04/2015
Date of final enrolment	30/09/2015

Locations

Countries of recruitment

Jordan

Study participating centre

King Hussein Medical Center

Amman
111985
Jordan

Sponsor information

Jordan University
University/education

Queen Rania St
Amman
111803
Jordan

Phone	(+962) 6-5355 000
Email	admin@ju.edu.jo
"ROR"	https://ror.org/05k89ew48

Funders

Funder type

Hospital/treatment centre

King Hussein Medical Centre

No information available

Results and Publications

Intention to publish date	01/08/2016
Individual participant data (IPD) Intention to share	Yes
IPD sharing plan summary	Available on request
Publication and dissemination plan
IPD sharing plan