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
Study website
Contact information
Type
Public
Contact name
Dr Leena Smadi
ORCID ID
Contact details
PO Box 830453
Amman
111803
Jordan
00962797197875
alsomadi@yahoo.com
Additional identifiers
EudraCT/CTIS number
IRAS 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(s)
Not provided at time of registration
Study design
Comparative cross sectional survey
Primary study design
Observational
Secondary study design
Cross sectional study
Study setting(s)
Hospital
Study 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
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
Overall study end date
30/09/2015
Reason abandoned (if study stopped)
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(s)
Patient
Age group
Adult
Sex
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
Study 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
ROR
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
Individual participant data (IPD) sharing plan
IPD sharing plan summary
Available on request
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|