Condition category
Oral Health
Date applied
12/06/2016
Date assigned
15/06/2016
Last edited
15/06/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

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

Trial website

Contact information

Type

Public

Primary contact

Dr Leena Smadi

ORCID ID

Contact details

PO Box 830453
Amman
111803
Jordan
00962797197875
alsomadi@yahoo.com

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

201/5/2015

Study information

Scientific title

Apical periodontitis and endodontic treatment in patients with type 2 diabetes mellitus: comparative cross sectional survey

Acronym

Study hypothesis

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

Not provided at time of registration

Study design

Comparative cross sectional survey

Primary study design

Observational

Secondary study design

Cross sectional study

Trial setting

Hospitals

Trial type

Screening

Patient information sheet

No participant information sheet available

Condition

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

Phase

Drug names

Primary outcome measures

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 trial start date

01/11/2014

Overall trial end date

30/09/2015

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

300

Participant exclusion criteria

Participants that do not fulfill the inclusion criteria

Recruitment start date

01/04/2015

Recruitment end date

30/09/2015

Locations

Countries of recruitment

Jordan

Trial participating centre

King Hussein Medical Center
Amman
111985
Jordan

Sponsor information

Organisation

Jordan University

Sponsor details

Queen Rania St
Amman
111803
Jordan
(+962) 6-5355 000
admin@ju.edu.jo

Sponsor type

University/education

Website

Funders

Funder type

Hospital/treatment centre

Funder name

King Hussein Medical Centre

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Intention to publish date

01/08/2016

Participant level data

Available on request

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes