Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT05170880 |
| Other study ID # |
Dr. Aparna |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
February 11, 2019 |
| Est. completion date |
August 30, 2019 |
Study information
| Verified date |
January 2019 |
| Source |
Postgraduate Institute of Dental Sciences Rohtak |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
To evaluate the effect of primary non-surgical endodontic therapy on glycaemic control in
type 2 diabetic patients with asymptomatic apical periodontitis.After fulfilling the
eligibility criteria, patients will be informed about the study and written consent to
participate in the study will be acquired from each patient after explaining risks, benefits
and alternative treatments.The endodontic treatment for all patients will be performed by a
single operator (S.A) following a standardized protocol. The control group will receive no
endodontic treatment during the study period. After completion of the study, these patients
will be given primary non-surgical endodontic treatment. The patients in control group will
be rendered the necessary treatment, if they become symptomatic and/or deny the consent
during the course of the study. These patients will be excluded from the study.
Description:
INTRODUCTION:
Diabetes mellitus (DM) is a clinically and genetically heterogeneous group of disorders
affecting the metabolism of carbohydrate, lipid or proteins, in which hyperglycemia is the
main feature. These disorders are either due to insulin deficiency related to autoimmune
destruction of pancreatic beta cells (type 1) or target tissue resistance to its cellular
metabolic effects (type 2).1 Patients suffering from DM are known to have increased
susceptibility to infections2.Evidence has consistently indicated that DM is a risk factor
for increased severity of periodontal disease3,4.
Apical Periodontitis (AP) is an acute or chronic inflammation of the periodontium located at
the root apex caused by bacterial infection of the pulp canal system5.
Traditionally, DM is diagnosed by either fasting or postprandial blood glucose but since 2010
American Diabetes Association (ADA) has recommended mean HbA1c as diagnostic criteria of
diabetes with its threshold level of 6.5%. HbA1c is a resulting product of hemoglobin and
glucose interaction and its elevated level indirectly reflects the hyperglycemic condition
i.e. DM. Studies have been conducted linking periodontal disease and diabetes mellitus in
terms of prevalence and worsening of glycemic control in diabetics as well as effect of
periodontal treatment on glycemic control in diabetic patients. Nevarro-Sanchez et al showed
significant improvement in HbA1c levels after non surgical periodontal therapy in diabetic
patients .
The aim of the present trial is to evaluate the effect of endodontic therapy on glycemic
status in patients with apical periodontitis.
AIM AND OBJECTIVES:
To evaluate the effect of primary non-surgical endodontic therapy on glycaemic control in
type 2 diabetic patients with asymptomatic apical periodontitis.
MATERIALS AND METHODOLOGY:
This study will be conducted in the department of conservative dentistry and endodontics,
Post Graduate Institute of Dental Sciences (PGIDS), Rohtak. Study subjects will be obtained
from the pool of OPD patients in the Department of conservative dentistry and endodontics,
PGIDS, Rohtak.
Study Design: Intervention Study period: December Study subjects: 30
Baseline parameters -- Endodontic evaluation - Pulp sensibility testing will be performed
with a combination of heat test, cold test and electric pulp test. Teeth not responding to
both thermal and electric test will be considered non vital.
Radiographic evaluation - Radiographs with paralleling cone technique at baseline and at
subsequent appointment (3 months) will be taken at standardized exposure parameters.
Glycemic Control Assessment To determine the metabolic control status of diabetic patients,
HbA1c will be registered on the day of treatment initiation. For the metabolic assessment,
venous blood samples will be taken from each patient and analysed for glycated haemoglobin
(HbA1c). Metabolic measurements will be performed at baseline and at 3rd month following the
endodontic treatment in the treatment and control group.
Randomization: Patients will be randomly allocated by envelope method into two groups-
intervention group (IG) , Group II= Control group (CG). The opaque envelopes will be prepared
by an independent observer blinded to the treatment groups. The patients will be asked to
choose an envelope at the time of recruitment which will decide the group into which patient
will be allocated.
Methodology:
After fulfilling the eligibility criteria, patients will be informed about the study and
written consent to participate in the study will be acquired from each patient after
explaining risks, benefits and alternative treatments. Prior to treatment a thorough clinical
and radiological examination will be carried out and thorough history will be taken from each
patient. Patients will be instructed to continue with their medical treatment of DM (oral
hypoglycemic agents), diet and life style without modifications during the study period.
Clinical Procedure:
The endodontic treatment for all patients will be performed by a single operator (S.A)
following a standardized protocol. After local anesthesia administration (2 % xylocaine with
1:80000 epinephrine), access cavity will be prepared using under rubber dam isolation. After
pulp chamber debridement and canal orifices identification, coronal shaping & enlargement
will be performed with low speed gates-glidden drills to obtain straight line access to the
apical third of each root canal. Working length will be determined with the help of Root ZX
apex locator and verified radiographically. Canals will be prepared using the crown down
technique with rotary instruments. Canals will be irrigated with 5 ml of 5.25 % sodium
hypochlorite (NaOCl) subsequent to change of each instrument. After complete canal
instrumentation, the canals will be irrigated with 5.0 ml of 17% ethylene-diaminetetra acetic
acid for 1 minute followed by a final irrigation with 5.0 ml of 5.25% NaOCl. Canals will be
filled with a paste of calcium hydroxide and access will be sealed temporarily with
Intermediate Restorative Material. Patient will be scheduled for second visit after one week.
At the next appointment, the paste will be removed with Hedstrom files followed by copious
irrigation with 5.25% NaOCl. Canals will be obturated using lateral condensation technique.
After obturation, the cavity will be permanently restored. Immediate post-operative
radiograph will be taken using preset exposure parameters with a Rinn paralleling device.
The control group will receive no endodontic treatment during the study period. After
completion of the study, these patients will be given primary non-surgical endodontic
treatment. The patients in control group will be rendered the necessary treatment, if they
become symptomatic and/or deny the consent during the course of the study. These patients
will be excluded from the study.
Post - Operative Follow-Up:
Patients will be evaluated after 3 months. Radiograhic evaluation: periapical radiographs
will be taken to observe the healing.
Metabolic evaluation: For the metabolic assessment patients will be analysed for glycated
haemoglobin (HbA1c).
Clinical evaluation: Patients will be evaluated for the presence of any abnormal clinical
findings.
Statistical analysis Shapiro Wilk test will be used to analyze the distribution of data.
Categorical data will be analyzed by chi square test. Regression analysis will be done to
observe any association between independent and dependent variables.
Interobserver/intraobserver reliability will be analyzed with Cohen kappa analysis
