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CTRI Number  CTRI/2020/12/029532 [Registered on: 03/12/2020] Trial Registered Prospectively
Last Modified On: 02/12/2020
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Comparison of propolis and calcium hydroxide as Intracanal medicament in reducing post instrumentation pain in root canal treatment 
Scientific Title of Study   PROPOLIS VERSUS CALCIUM HYDROXIDE AS INTRACANAL MEDICAMENT IN RELIEVING POST INSTRUMENTATION PAIN: A RANDOMIZED CLINICAL TRIAL 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Narayan Kumar Chaudhary 
Designation  Junior Resident 
Affiliation  BP Koirala Institute of Health Science 
Address  Department of conservative dentistry and endodontics, BPKIHS Room No 8



00977
Other 
Phone  9842350738  
Fax    
Email  sanuchaudhary11@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Nabin Agrawal  
Designation  Additional Professor 
Affiliation  BP Koirala Institute of Health Science 
Address  Department of conservative dentistry and endodontics, BPKIHS Room No 8



00977
Other 
Phone  9852047395  
Fax    
Email  mailingnavin@gmail.com  
 
Details of Contact Person
Public Query  
Name  Narayan Kumar Chaudhary 
Designation  Junior Resident 
Affiliation  BP Koirala Institute of Health Science 
Address  Department of conservative dentistry and endodontic,BPKIHS



00977
Other 
Phone  9842350738  
Fax    
Email  sanuchaudhary11@gmail.com  
 
Source of Monetary or Material Support  
Department of Conservative dentistry and Endodontic,College of dental Surgery, BPKIHS 
 
Primary Sponsor  
Name  College of dental surgery 
Address  Department of conservative dentistry and endodontic 
Type of Sponsor  Research institution 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     Nepal  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Narayan Kumar Chaudhary  College of Dental Surgery,BPKIHS  Department of conservative dentistry and endodontics,BPKIHS Room no-8

 		 9842350738

sanuchaudhary11@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Review Commette  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K044||Acute apical periodontitis of pulpal origin,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Intervention is Root Canal Treatment. comparator agent, Propolis powder Control- Ca(OH)2 powder   The patients meeting the inclusion criteria are randomly allocated to the two treatment groups (Experimental and Control Group). Control group receive calcium hydroxide which is comparator agent and experimental group receive propolis as intracanal medicament. Calcium hydroxide have used for various purposes like direct and indirect pulp capping, and intracanal medicament. It is still the most commonly used intracanal medicament. The antimicrobial properties of calcium hydroxide is related to its high pH and releases hydroxyl ions that results bacteria unable to survive. Incomplete elimination of gram-negative bacteria, questionable healing of periapical lesions is its limitations. Propolis is a byproduct, prepared by honey bees which has broad spectrum of biological activities. Flavonoid being a major component of propolis, are greatly responsible for pharmacological activities of it. The mechanism by which propolis induces its anti-inflammatory and analgesic action is through suppression of LPS-induced inflammatory response of key cells. NRS is a tool designed to measure and quantify subject experiences such as pain and distress. The scale includes a 1 to 10 number where ‘0’ is ‘no pain’ and ‘10’ is ‘worst possible pain’. The patients are asked to estimate the intensity of the pain before initiating the treatment and score will be noted. At the first appointment, all patients will be anesthetized local infiltration or nerve block depending on area of interest. After rubber dam isolation, the access cavity will be performed. The working length (WL) will be first determined with an apex locator using No. 10 and 15 K-files and later confirmed radiographically. A size 10 K- file will be used to maintain apical patency 1 mm beyond the WL. The canal will be prepared in crowndown fashion using ISO hand files with hand and rotary Protaper Universal Ni-Ti files upto F2. Once, the chemo-mechanical cleaning is done using with 31 Gauge side vented syringe, the root canal will be dried, intracanal medicament as per the protocol upto 1-2 mm short of working length. Group I will be the experimental group that will receive propolis as intracanal medicament. Group II will be the control group that will receive calcium hydroxide as intracanal medicament. The patients will be unaware of the intervention, whether they will be receiving the propolis or calcium hydroxide as intracanal medicament. The participants will remain blind to the treatment allocation throughout the trial A temporary filling will then be placed, and the occlusion will be adjusted and in second visit root canal treatment is completed. After this procedure, NRSs will be recorded to register the level of pain at 4 hours, 12 hours, 24 hours,48 hours and 72 hours after instrumentation via telephone. Now the pain reduction after instrumentation using calcium hydroxide and propolis is compared in between the groups at different time.  
Comparator Agent  Propolis  It is product from Y.S. ECO FARMS. It is in powder form of propolis. Propolis is a flavonoid rich resinous natural product extracted from honeybees. It has anti-microbial, anti-inflammatory, antifungal and healing properties. Propolis consists of flavonoids which stimulate reparative dentine formation and also delay pulp inflammation by stimulating production of transforming growth factor (TGF)-β1 and synthesis of collagen by dental pulp cells. It has been also used as pulp capping agent, as storage media for avulsed teeth, for prevention of caries and dentine hypersensitivity. Due to its antibacterial and anti-inflammatory properties, it can be used as an intracanal medicament for disinfection of the root canal system. It is found to be effective against E.faecalis, S. aureus and C.albicans and other endodontic pathogens. It also decreases Lipopolysaccharide(LPS) which induced inflammation. Although no harmful effect of propolis has been reported till date, the only adverse effect of propolis is its potential to cause allergic contact dermatitis. Furthermore, several studies have shown that components of intracanal medicaments are able to diffuse through dentinal tubules, ramifications and apical foramen to exert their effect in inaccessible areas inside the tooth and periapical area. Propolis being effective against endodontic pathogens, it is expected to reduce the occurrence and severity of post endodontic pain in necrotic teeth.  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details   Nepalese patients ≥ 18 years of age
 Patient presenting with symptomatic apical periodontitis
 Tooth with single canal.
 Patient registering pain 4 onward in a Numeric Rating Scale (NRS) scale of 1-10 preoperatively.
 Patient who can understand and provide informed consent
 
 
ExclusionCriteria 
Details  Patient not willing to participate in the study and communication cannot be accomplished
Root canal re-treatment
Root canals with an extreme curvature [>30°]
Internal or external resorption of root
Tooth with open apices
Radiographically untraceable canal path
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
The effect of propolis and [Ca(OH)2] as intracanal medicament in relieving post instrumentation pain in symptomatic apical periodontitis will be measured  4 hrs, 12 hrs, 24 hrs, 48 hrs and 72 hrs 
 
Secondary Outcome  
Outcome  TimePoints 
• To compare the effect of propolis and calcium hydroxide paste as intracanal medicament in relieving post instrumentation pain at different time intervals.  4 hrs, 12 hrs, 24 hrs, 48 hrs and 72 hrs 
 
Target Sample Size   Total Sample Size="44"
Sample Size from India="0" 
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)   Date Missing 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  15/12/2020 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="20"
Months="11"
Days="30" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
Recruitment Status of Trial (India)  Not Applicable 
Publication Details   NIL 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  

Pain is significant factor due to which a patient visits a dental practice. Usually, pain of pulpal origin requires endodontic therapy to reduce symptoms. Postoperative pain following root canal instrumentation can be embarrassing for the dentist and annoying for the patient. Irrespective of standard care for endodontic therapy, pain after treatment is a regular event for which there are many causes and bacteria is one of the significant factors. Chemo-mechanical preparation of root canal using sodium hypochlorite irrigation results in 40-60% reduction of bacterial load in root canals, but 60-40% of the canals still remain infected with pathogenic bacteria. However, for efficacious decrease in bacterial load, meticulous instrumentation and intracanal irrigation are needed. It also requires an effective intracanal medicament that reduce bacteria and their byproducts from root canal system and thereby decrease chance of inter appointment pain indirectly. Secondly, in order to eliminate and prevent pain and inflammation directly, an intracanal medicament must have an anti-inflammatory component in it.

                   Calcium hydroxide [Ca(OH)2] is most commonly used intracanal medicament. Calcium hydroxide has antibacterial effect due to release of hydroxyl ion when it is in aqueous fluid. It has been proved to be ineffective against some of the detrimental endodontic pathogens and lacks anti-inflammatory component.

                Propolis, a natural product from bees, is effective against resistant microbes and has anti-inflammatory properties which is cheaper compared to other synthetic medicaments.  It consists of flavonoid component that has antibacterial and anti-inflammatory properties.  Propolis showed 100% reduction of E. faecalis in 2 days. Antibacterial action for propolis is due to its flavonoid content, various esters of caffeic acid, galangin (3,5,7-trihydroxyflavone), and its bioautogram components. In addition, propolis has the ultraviolet -absorbing component shown to inhibit bacterial DNA- dependent RNA polymerase. Propolis have been used before as intracanal medicament and have shown to be effective. The literature lacks significant studies that investigates the role of Propolis in post instrumentation pain. Henceforth, this study has attempted to evaluate Propolis as intracanal medicament in reducing post instrumentation pain and fill the knowledge gap.

 
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