FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2020/02/023370 [Registered on: 17/02/2020] Trial Registered Prospectively
Last Modified On: 17/02/2020
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Randomized, Parallel Group, Multiple Arm Trial 
Public Title of Study   Effect of different medicine to be placed inside the tooth canal, on the pain after root canal treatment in diabetic and non-diabetic patients 
Scientific Title of Study   Effect of calcium hydroxide as an intracanal medicament on postoperative pain in diabetic and non-diabetic patients- a randomized control trial 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Alka Gurawa 
Designation  Post Graduate student 
Affiliation  Manav Rachna Dental College 
Address  Department of conservative dentistry and endodontics, Manav Rachna Dental college, sector- 43

Faridabad
HARYANA
121004
India 
Phone  8527064334  
Fax    
Email  alkagurawa@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Arundeep singh 
Designation  Proffesor and principal 
Affiliation  Manav Rachna Dental College 
Address  Department of Conservative and Endodontics, Manav Rachna Dental College

Faridabad
HARYANA
121004
India 
Phone  8527064334  
Fax    
Email  principal.mrdc@mrei.ac.in  
 
Details of Contact Person
Public Query
 
Name  Dr Alka Gurawa 
Designation  Post Graduate student 
Affiliation  Manav Rachna Dental College 
Address  Department of conservative dentistry and endodontics, Manav Rachna Dental college, sector- 43

Faridabad
HARYANA
121004
India 
Phone  8527064334  
Fax    
Email  alkagurawa@gmail.com  
 
Source of Monetary or Material Support  
Manav Rachna Dental college, sector- 43, Faridabad 
 
Primary Sponsor  
Name  Manav Rachna Dental college 
Address  Manav Rachna Dental college, sector- 43, Faridabad, Haryana 
Type of Sponsor  Private medical college 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Alka Gurawa  Manav Rachna Dental college,  Room no. 7, Second floor, Manav Rachna Dental college,, Sector-43, Faridabad,
Faridabad
HARYANA 
08527064334

alkagurawa@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL ETHICS COMMITTEE  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Human volunteers with a mandibular molar teeth that were diagnosed with Necrotized Apical periodontitis 
Patients  (1) ICD-10 Condition: E08-E13||Diabetes mellitus,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Calcium hydroxide  Calcium hydroxide used as an intracanal medicament in intervention group. Paste will be formed by mixing 1gm of Ca(oh)2 with 1.5 ml of distilled water. Calcium hydroxide is placed as medicament in two groups with help of lentiluspiral 
Comparator Agent  Placebo  No intracanal medicament shall be placed in the root canal. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  a)Mandibular posterior teeth with necrosis and symptomatic Apical periodontitis
b) Teeth with mature apices less than 60yrs
 
 
ExclusionCriteria 
Details  a) Patients who had taken analgesics or anti-inflammatory drugs within the last 6 hours.
b) Teeth with calcified canals.
c)Pregnant or lactating patients
d)Teeth with previous RCT
e)Patients with history of allergy to any of the components of LA
 
 
Method of Generating Random Sequence   Permuted block randomization, fixed 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant, Investigator and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Post-operative pain   Post-operative pain will be evaluated after 6, 24, 48, 72 hours and consecutively for 4 more
days with the help of heft parker scale
 
 
Secondary Outcome  
Outcome  TimePoints 
No secondary outcomes  No secondary outcomes 
 
Target Sample Size   Total Sample Size="96"
Sample Size from India="96" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   N/A 
Date of First Enrollment (India)   17/02/2020 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   The data shall be published in a high impact factor journal. 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary  

INTRODUCTION

Postoperative pain is defined as pain of any degree after initiation of endodontic treatment either intra-appointment or post-obturation and is considered an undesirable occurrence for both patient and dentist. Diabetes mellitus(DM) is a complex metabolic disease, characterized by hyperglycemia resulting from defects in insulin secretion, insulin action or both. In patients with DM, several aspects of the immune system are compromised and wound healing is impaired. 

Studies indicate that diabetic patients have increased prevalence of severe periapical lesions and a decreased success rate of endodontic treatment, suggests that periapical lesions can be modified by diabetes. “During an inflammatory response, leukocytes adhere to endothelial cells due to the presence of adhesion receptors on leukocytes and endothelial cells. The leukocytes eventually become firmly attached to the vascular wall before migrating into tissues. Accordingly,  one possible explanation for the abnormal leukocyte function in DM might be a down regulation of adhesion molecules leading to decreased leukocyte– endothelial cell interactions and a reduced number of leukocytes in inflammatory lesions.”[7]

 It was suggested that major cause of postoperative pain is bacterial injury in endodontics. After instrumentation and irrigation Intra-canal medicaments are widely used to kill any bacteria surviving.  It is reported that incidence of flare-up are more in patients with diabetes mellitus due to severe endodontic infections.[8] This is attributed to alterations in immune functions and the presence of more virulent microorganisms in root canals of diabetic patients.

Calcium hydroxide is most commonly used medicament throughout the world. It has pain preventive properties because of its antimicrobial property and tissue repair effect. Purpose of this study is to compare postoperative pain in diabetic and non diabetic patient during root canal treatment with medicament and without medicament.

AIM AND OBJECTIVES

 

AIM:

to compare post operative pain in diabetic and non- diabetic patient        during root canal treatment with and without  ca(oh)2 in cases of necrosis with    symptomatic apical periodontitis

 

OBJECTIVE:

1)     To evaluate pain in diabetic patients undergoing root canal treatment with Ca(OH)2

2)     To evaluate pain in diabetic patients undergoing root canal treatment without Ca(OH)2

3)     To evaluate pain in Non-diabetic patients undergoing root canal treatment with Ca(OH)2

4)     To evaluate pain in Non-diabetic patients undergoing root canal treatment without Ca(OH)2

5)     To compare pain perception in diabetic and Non-diabetic patient

A.   STUDY DESIGN:

Interventional Study (Randomised Control Trial)

B.   STUDY SUBJECTS:

·       96 patients

SAMPLE SELECTION

Patients with Necrotized Apical periodontitis on mandibular first reporting to Department of Conservative Dentistry & Endodontics at Manav Rachna Dental College, Faridabad will be selected and Informed Consent will be taken.

-      SAMPLE SIZE- 96

-       At least 24 patients in each  group are required  with Alpha, beta errors of 0.05 and 0.20,  and power of study will be 80%

INCLUSION CRITERIA

•       1)  Mandibular molar teeth that were diagnosed with Necrotized Apical periodontitis

•       2)  Teeth with mature apices

•      3)   Patients with age less than 60 yrs

EXCLUSION CRITERIA

•       1)  Patients who had taken analgesics or anti-inflammatory drugs within the last 12 hours.

•        2)Teeth with calcified canals.

•        3)Pregnant or lactating patients

•       4)  Patients with history of allergy to any of the components of local anesthesia

•       5)  Teeth with previous RCT

•       6)  Teeth with severe damage

 

 

 

 

                                                         METHODOLOGY

N=96

(permanent mandibular posterior teeth with mature apices)Pulp sensibility test will be done with the help of EPT and cold test

 

 

Patient will be diagnosed in the opd wether he/she is diabetic or non-diabetic by Random Blood Sugar test (> 200 mg/dl) by glucometer

 

 

Confirmatory test for diabeties will be done by fasting blood sugar (> 126 mg/dl) and HbA1C test

(1) Non-diabetic  =  < 5.4           ( 2) Pre-diabetic   =  5.4 - 6.7                   (3) Diabetic  =  > 6.7

 

 

 


Four groups – Two group of diabetic and Two group of Non-diabetic

 

 


Patients will be asked to complete the Heft parker scale before giving LA

Tooth will be anaesthetized with local anesthesia 2% lidocaine with 1:80,000

 

 

Tooth will be isolated with Rubber Dam and disinfection of surrounding areas will be established

After relieving occlusion access opening will be performed ,  patency of canal will be checked with  #10K file.

 

 

Working length will be measured by apex locater and checked by radiograph. Cleaning &shaping of the canal will be done using Niti Rotary files. Copious irrigation with 2ml , 3% NaOCl will be used between the instrumentation.

 

 

3ml 17% EDTA used to remove smear layer 1 min

 

 

 


copious irrigation with 3% NaOCL will be done

 

 


canal will be flushed with 5ml normal saline

 

 


after final irrigation, canal will be dried and medicament placement will be done The patients randomly divided into 4 groups.  Randomization to be done using online randomization generator(www.randomization.com)

GROUPING

GROUP -A GROUP- B    GROUP-C  GROUP- D    

GROUP A- Non-Diabetic patient with necrotized apical periodontitis

-Calcium hydroxide will be used as an intracanal medicament

GROUP B- Diabetic patient with necrotized apical periodontitis

            -      Calcium hydroxide will be used as intracanal medicament

GROUP C-  Diabetic patient with necrotized apical periodontitis

No intra canal medicament used

GROUP D- Non-Diabetic patient with necrotized apical periodontitis

             -     No intracanal medicament used

 

 


                                 CALCIUM HYDROXIDE PREAPARATION

Paste will be formed by mixing 1gm of Ca(oh)2 with 1.5 ml of distilled water. Calcium hydroxide is placed as medicament in two groups with help of lentiluspiral

 

 


                    Tooth will be temporized and patient will be recalled after 1 week

    Post-operative pain will be evaluated after 6, 24, 48, 72 hours and consecutively for 4 more

days with the help of heft parker scale.

.

 

After one week canals will be obturated using cold lateral compaction technique with gutta percha and AH Plus sealer.

STATISTICAL ANALYSIS

The data will be statistically analyzed using suitable statistical test such as ANOVA test or Kruskal / wallis test


 
Close