Clinical trial NCT03723980
Conditions: Pain, Postoperative
Keywords: Flare up
Sponsor: Juzer Shabbir Saifee
Start date: 2017-11-16; Completion date: 2018-10-15
Enrollment: 80 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study evaluates the role of propolis paste as compared to calcium hydroxide (when used as intracanal medication) in prevention and treatment of pain after root canal treatment in necrotic (infected) teeth. Half of the participants will receive calcium hydroxide, while the other half will receive propolis.

Detailed description:
Propolis is a developing herbal medicament used in various aspects on dentistry. it is extremely biocompatible; has flavanoids; which acts as anti-inflammatory and antimicrobial components.

Calcium hydroxide is a synthetic medication which is antibacterial

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Propolis intervention 2: Calcium Hydroxide
Intervention descriptions: intervention 1: it is a natural product obtained from beehive. it has been evaluated for biocompatibility and toxicity; and it is found that it is extremely biocompatible material. In our study, propolis powder will be mixed with saline in a ratio of 1 : 1.5 (propolis powder(wt) / saline(vol)) to form paste; and inserted into the root canals. it will be inserted once and will remain in root canals for 4 days. intervention 2: it is a synthetic antimicrobial intracanal medicament and gold standard to which other medicaments are being compared. approximately 150 mg of calcium hydroxide paste will be inserted in the root canal. it will be inserted only once and will remain in root canals for 4 days.

Protocol documents:
Prot_SAP_ICF_000.pdf: 
1  
  
  
  
EFFECT OF PROPOLIS PASTE AS INTRACANAL  
MEDICAMENT ON POST-ENDODONTIC PAIN: A DOUBLE 
BLIND RANDOMIZED CLINICAL TRIAL  
  
SYNOPSIS  
Approved by the Scientific Committee  
Approved by Institutional Review Board  
Approved by Board of Advanced Studies and Research  
Trial registered with ISRCTN (Biomed Central) – ISRCTN66816132  
Dow University of Health Sciences  
In partial fulfillment of the requirement  
For the Degree of  
Masters in Dental Surgery   
By  
Dr. Juzer Shabbir Saifee  
  
Dr. Ishrat-ul-Ibad Khan Institute of Oral Health Sciences  
Dow University of Health Sciences  
Karachi, Pakistan  
14 November, 2017  
  
  
  
CORRESPONDING SUPERVISOR:  
  
Dr. Fazal-ur-Rehman Qazi  


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TABLE OF CONTENTS  
Title………………………………………………………………………………………………………………………………………………….1  
Certificate………………………………………………………………………………………………………………………………………..2  
Contents…………………………………………………………………………………………………………………………………………..3  
ABSTRACT………………………………………………………………………………………………………………………………………..4  
CHAPTER 1: INTRODUCTION   
      1.1. Background…………………………………………………………………………………………………………………………..6  
      1.2. Literature Review………………………………………………………………………………………………………………….8  
      1.3. Rationale of Study……………………………………………………………………………………………………………….10  
      1.4. Statement of Problem…………………………………………………………………………………………….……………10  
      1.5. Objectives……………………………………………………………………………………………………………………………11  
      1.6. Hypothesis…………………………………………………………………………………………………………………………..11  
      1.7. Operational Definitions………………………………………………………………………………………………………..11  
CHAPTER 2: METHODOLOGY  
      2.1. Study Design………………………………………………………………………………………………………………………..13  
      2.2. Study Setting……………………………………………………………………………………………………………………….13  
      2.3. Study Duration…………………………………………………………………………………………………………………….13  
      2.4. Study Population…………………………………………………………………………………………………………………13  
      2.5. Sample Size………………………………………………………………………………………………………………………….14  
      2.6. Sampling Technique…………………………………………………………………………………………………………….15  
      2.7. Data Collection Procedure……………………………………………………………………………………………………16  
      2.8. Study Variables…………………………………………………………………………………………………………………….17       
2.9. Statistical Analysis……………………………………………………………………………………………………………….18  
CHAPTER 3: REFERENCES AND APPENDICES……………………………………………………………………………………19  
 
 
 
 
 
 


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ABSTRACT  
Background:  
Dental pain is a significant factor due to which the patient seeks treatment. Non-surgical Endodontic 
treatment is a major therapy to treat the pain and save the tooth. Pain control during this endodontic 
procedure is a challenging goal for dental practitioners. Patients having necrotic teeth have the highest 
incidence of post-endodontic pain, therefore, it needs special attention.   
To prevent post-endodontic pain, different techniques have been adapted. Placing biocompatible 
medications having either potent antimicrobial activity or anti-inflammatory component or both inside 
the root canals is one of the eminent techniques to disinfect the canals and control the pain. Calcium 
hydroxide is the most common intracanal medicament to which all other medicaments are being 
compared but it carries certain drawbacks with it. It is ineffective against E.faecalis and Fungi, lacks 
anti-inflammatory component and is controversial in preventing pain. Presently, focus of research has 
shifted towards natural alternatives to synthetic intracanal medication. Propolis is an organic resinous 
substance obtained from bee hive. It is nontoxic, biocompatible, anti-inflammatory, anti-oxidant, and 
anti-microbial and is effective against E.faecalis and fungi.  
Objective:  
To evaluate the effect of Propolis paste on post-endodontic pain in comparison to calcium hydroxide at 
different time intervals.  
Trial Design:  
A parallel group prospective double blind randomized control (clinical) trial.  
Methods:  
This study will be conducted in Department of Endodontics, Dow International Dental College within  
1 
year after approval. 80 patients having painful, single rooted necrotic teeth with PAI index 3 
and 4 will be selected and randomly assigned to either control (Group I) or experimental (Group II). 
Randomization will be computer generated and the produced sequence will be placed in sealed envelope 


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with allocation concealment from the principal researcher. Patients will be blinded to group assignment 
and the principal researcher will be blinded from the type of intracanal medicament being inserted. 
Standard non-surgical endodontic procedure will be performed by the principal researcher till root canal 
preparation is completed. Intracanal medicaments will then be inserted by a secondary operator in the 
first visit. In Group I, calcium hydroxide will be inserted. In group II (experimental), Propolis powder 
mixed with saline will be inserted. Visual Analogue Pain Scale will be provided to the patients to rate 
their pain intensity pre-operatively, then at 4 hours, 12 hours, 24 hours, 48 hours and 72 hours  after 
treatment. Visual analogue scales will be collected after 4 days.   
Statistical Analysis:  
Analysis of the data will be done through IBM SPSS v24. Flare-up will be identified as increase of 20 
or more points on Visual analogue scale from initial pain score. Repeated Measure ANOVA will be 
used to compare pain scores between the groups at various time intervals; Mann-Whitney U test will be 
applied for comparison of pain between gender; and Kruskal-Willis test will be applied for comparison 
of pain between age groups. Crosstabs will be used to report the rate of flare-up.  
  
Key words:  
Propolis, Calcium hydroxide, Pain, Flare up, Intracanal Medications, Necrotic teeth.  
  
  
  
  
 
 
 


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CHAPTER 1: INTRODUCTION  
1.1 - Background:  
Dental Pain is a significant factor, due to which the patient seeks  treatment and endodontic therapy is 
a major treatment to alleviate the pain(1). The occurrence of mild pain after root canal preparation is not 
uncommon(2). But sometimes, endodontic procedure can result in flare-up. Flare up can be defined as 
severe pain and/or swelling of the area of endodontically treated tooth occurring within few hours to 
few days following initiation and/or completion of root canal treatment(3). Severe post-endodontic pain 
is an emergency, which requires a prompt intervention. Failure to control the post endodontic pain 
results in demotivation of the patient and eventual extraction of the affected tooth.   
The cause of post-endodontic pain is the peri-radicular inflammation which results due to extrusion of 
irritants from the root canals into the periapical region(3). These irritants might be of nonmicrobiological 
and microbiological origin(4). Non-microbiological cause is mainly due to iatrogenic errors; inaccurate 
working length estimation, in-correct method of root canal preparation, overinstrumentation and 
extrusion of obturating materials, intracanal medicaments and chemical irrigants(3). These iatrogenic 
errors can be controlled by carefully performing endodontic procedures. But sometimes, even after 
careful and judicious endodontic procedure, flare up occurs, which is due to microbiological cause(5). 
The microbiological factor is the most common cause of peri-radicular inflammation. It includes the  
apical extrusion of infected debris, changes in endodontic microbiota or in environmental conditions, 
secondary intra-radicular infection and increase in oxidation-reduction potential(5). The Bacteria which 
are predominant in symptomatic apical periodontitis are  Parvimonas micra, Eubacterium, 
Porphyromonas and Prevotella(3). Many chemical mediators are responsible for the occurrence of pain 
during inflammation. Few examples are; histamine, serotonin, prostaglandins, platelet activating factors 
and leukotrienes. Certain plasma mediators are also directly or indirectly involved in induction of pain, 
like; Hageman factor, Bradykinin and fibrinopeptides(6).  


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In some studies, the incidence of flare-up is found to be upto 50% (7-9). According to a systemic review, 
mean post-treatment pain prevalence at 24 hours is 40%. Moreover, moderate pain severity was reported 
to be 24% at 24 hours(1). In a meta-analysis, frequency of flare-up was found to be 8.4%  
(10).  
Management of flare up includes prescribing analgesics and antibiotics, performing occlusal reduction, 
re-instrumentation,  placing of intracanal medications, incision and drainage, and cortical trephination 
(11). Although, chemo-mechanical preparation using sodium hypochlorite irrigation is of paramount 
importance for reduction of bacterial load in root canals, but 40-60% of the canals still remain  infected 
with pathogenic bacteria(12-14). Intracanal medicaments are recommended to supplement the chemo-
mechanical preparation and eliminate the persistent bacteria in the root canal  
system (14, 15).  
According to Walton(16), The role of intracanal medicament is to; eliminate the microbes, render canal 
contents inert, control persistent periapical abscesses, prevent or control post-treatment pain and 
enhance anesthesia. The most commonly used intracanal medicament is Calcium hydroxide(2). 
Incomplete elimination of gram-negative bacteria, questionable healing of periapical lesions and inept 
elimination and prevention of post-endodontic pain (2, 4, 17) are some limitations of using calcium 
hydroxide.  Intracanal use of corticosteroid and antibiotic containing medication like ledermix paste has 
been found to be effective to control the post-endodontic pain(8). But, yeasts  are resistant to it(18) and 
ledermix paste is associated with discoloration of tooth(19). Also, it has been found to have a potential 
to cause increased degree of inflammation (20). More recently trends have shifted towards finding a 
natural organic alternative (21) to synthetic inorganic intracanal medicaments. Propolis is a natural 
product which has been used extensively in past(22). It has anti-microbial and antiinflammatory 
properties and can be used as an intracanal medicament for disinfection of the root canal system(23). 
Propolis is found to be effective against E.faecalis, S. aureus and C.albicans and other endodontic 
pathogens (24-26). It is also effective against some gram-negative bacteria(27). Propolis also decreases 


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Lipopolysaccharide(LPS) induced  inflammation(28). Although no harmful effect of propolis has been 
reported till date, the only drawback of propolis found is its potential to cause  
allergic contact dermatitis (29-31).  
As microbes are the most common cause of post endodontic pain, the incidence of post endodontic pain 
is reduced when intracanal medicaments are used for disinfection(5). 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 (32-38). Owing to the fact that Propolis is effective against endodontic pathogens and has 
anti-inflammatory component; flavonoid(39), it is expected to reduce the occurrence and severity of post-
endodontic pain in necrotic teeth. The aim of the present study is to test the clinical efficacy of propolis 
when used as intracanal medicament in reducing and preventing the post-endodontic pain as compared 
to calcium hydroxide.   
1.2 - Literature Review:  
As the non-surgical endodontics is developing, there have been significant development in prevention 
and treatment of post-endodontic pain but controversy remains on the effectiveness of the intracanal 
medicaments in reducing pain(3). There is also no systemic review or meta-analysis published till date 
about the role of intracanal medicament in prevention of post-endodontic pain.  
Calcium hydroxide has been broadly used for various purposes in dentistry since 1920s. Today, it is  
still the most widely used endodontic medicament all over the world(40). The mechanism of action by 
which calcium hydroxide kills the bacteria is related to its high pH. The micro-organisms are killed due 
to release of hydroxyl ions, which results in highly alkaline environment in which bacteria are unable 
to survive(41). Calcium hydroxide has also shown to inactivate bacterial lipopolysaccharide (LPS) and 
assist in periapical tissue healing(42). In few studies, calcium hydroxide has been reported to be useful 
in controlling inflammatory exudate from peri-radicular region. Mechanism behind this  
property might be related to its antimicrobial effect(43), capillary contraction(44) and apical plug 
formation(43). Clinically, it was suggested that calcium hydroxide had pain-relieving property due to its 


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antibacterial and tissue altering effects(45). But some authors have disagreed with this suggestion and 
reasoned that calcium hydroxide could initiate or increase pain by starting or exacerbating 
inflammation(46). Likewise, few studies have shown that calcium hydroxide has no impact on prevention 
or reduction of post endodontic pain (47-50).  
Propolis is a byproduct, prepared by honey bees which has broad spectrum of biological activities(51). 
Raw propolis consists of 50% plant resins, 30% waxes, 10% aromatic and essential oils, 5% pollens 
and 5% other organic substances(39). Propolis has been found to be effective in treating colds, wounds  
and ulcers, sprains, rheumatism, heart disease, diabetes(52-55) and dental caries(56-60) due to its 
antiinflammatory(55, 
61-63), anti-microbial, anti-oxidant, anti-tumor(64), anti-ulcer and anti-HIV 
properties(65). The main constituents of temperate climate region propolis are flavonoids without Bring 
substituents, like chrysin, Galangin, pinocembrin and pinobanksin(39). Being a major component of 
propolis, flavonoids are greatly responsible for pharmacological activities of it.   
Several studies have been conducted regarding potential use of propolis in dentistry. Some studies have 
shown that propolis is effective in preventing and treating gingival and periodontal disease (66-69). 
Propolis also has antiviral effects and can be used locally in viral infections(70). Propolis is extremely  
effective medium for avulsed tooth (71-73). Local application of propolis assist in healing wounds after  
oral surgery procedures, reduces inflammation and has analgesic effect(74, 75). Propolis has a positive  
effect on bone forming during expansion of palatine suture(76). It can reduce dentinal hypersensitivity 
by partially impregnating the tubules(77). Propolis can also be used effectively as a direct pulp capping  
agent (78-80).   
There are several in-vitro studies regarding the use of propolis in endodontics. In few studies, it has 
been shown that Propolis can eliminate E.faecalis and C.albicans and reduce endotoxin when used as  
an intracanal irrigant(81, 82). In some studies, propolis was found to be more effective than calcium  
hydroxide against endodontic pathogens when used as an intracanal medicament (83, 84). Furthermore, 
propolis has also been found to be superior to tri-antibiotic mixture against E.faecalis(85). Although, few 
studies have shown that chlorhexidine is more effective against E.faecalis as compared to propolis(83, 


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86). One study has shown that effectiveness of propolis is similar to chlorhexidine at 7 days(87). Regarding 
the biocompatibility and toxicity, propolis has been found to be least toxic and highly biocompatible as 
compared to other endodontic medicaments and materials (78, 88-91). The mechanism by which propolis 
induces its anti-inflammatory and analgesic action is through suppression of LPS-induced inflammatory 
response of key cells(92). Yet, there is no in-vivo study performed to show the efficacy of propolis paste 
in reducing inter-appointment pain.  
1.3 - Rationale Of Study:  
Necrotic teeth require an intracanal medicament which can effectively eliminate notorious bacteria and 
their byproducts from root canal system and thereby decrease chances of flare up and inter appointment 
pain indirectly by banishing the cause. Secondly, in order to eliminate and prevent pain and 
inflammation directly, an intracanal medicament must have an anti-inflammatory component in it. 
Calcium hydroxide has been proved to be ineffective against some of the detrimental endodontic 
pathogens and lacks anti-inflammatory component. To offset the draw back of a single intracanal 
medicament, two or more medicaments are mixed together which increases the cost. Propolis is a natural 
product which is effective against resistant microbes, is anti-inflammatory and cheaper than other 
synthetic medicaments. The literature lacks an in-vivo study that investigates the role of Propolis on 
post-endodontic pain. This study will be an attempt to fill this knowledge gap.  
  
1.4 - Statement Of The Problem:  
Do propolis paste have any significantly better effect on preventing and eliminating the postendodontic 
pain as compared to calcium hydroxide?  
  
  
 
 


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1.5 - Objectives:  
To evaluate the effect of Propolis paste on post-endodontic pain in comparison to calcium hydroxide at 
different time intervals.  
1.6 - Hypothesis:  
Null hypothesis (H0) = There will be no significant difference between Calcium hydroxide and Propolis 
paste in reducing and preventing post-endodontic pain.  
Alternative hypothesis (HA) = There will be a significant difference between Calcium hydroxide and 
Propolis paste group in reducing and preventing post-endodontic pain.  
1.7 - Operational Definitions:  
Necrotic teeth:   
The teeth which are tender to vertical percussion, have visible periapical widening or radiolucency on 
periapical radiograph without bone expansion (PAI index= 3 and 4) and shows no bleeding when the 
pulp chamber is opened.  
PAI index(93):  
• 
1-Normal Periapical structure  
• 
2-Small changes in bone structure not pathognomic of apical periodontitis  
• 
3-Changes in bone structure with some mineral loss characteristic of apical periodontitis  
• 
4-Periodontitis with well-defined radiolucency  
• 
5-Severe periodontitis with exacerbating features and bone expansion.  
VAS scale (94):   
• 
No pain= Pain score 0.  
• 
Mild pain intensity with no requirement of analgesics= Pain score 1- 24.  
• 
Moderate pain intensity with requirement of ibuprofen or similar medication= Pain score 25 –  
49.  


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• 
Severe pain intensity with requirement of narcotic analgesic= Pain score 50 – 74.  
• 
Extreme pain intensity, not relieved by any type of medication= Pain score 75 – 100.  
Flare-up:  
An increase of 20 or more points from initial intensity of pain on Visual Analogue Scale (VAS)(94).  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
 
 
 


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CHAPTER 2 : METHODOLOGY  
2.1 - Study Design:  
The study will be a parallel group prospective double blind randomized controlled trial, with equal 
randomization (1:1). The patients and the principal researcher will be blinded from the type of intracanal 
medicament inserted.   
2.2 - Study Setting:   
The study will be a multi-center research. It will be conducted in a secondary healthcare center; 
outpatient department of operative dentistry/endodontics in institutes / campuses of D.U.H.S, Karachi, 
Pakistan. It is a major commercial city of Pakistan having population of over 23.5 million(95).  
2.3 - Study Duration:  
One year.  
2.4 - Study Population:  
Adults (aged 20 – 40)  Inclusion 
criteria:  
• 
Single rooted Necrotic teeth with symptomatic or aysmptomatic periapical periodontitis having 
visible periapical widening or radiolucency without bone expansion (PAI index 3 and  
4).  
• 
Teeth with favorable root morphology.  
• 
Teeth with closed apex.  
Exclusion criteria:  
• 
Teeth with PAI index 1, 4 and 5.  
• 
Patients who are on antibiotics.  
• 
Patient with recent trauma to the jaw.  


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• 
Teeth with open apex  
• 
Multi-rooted teeth.  
• 
Vital teeth.  
• 
Non-restorable teeth.  
• 
Unfavorable root morphology (severely curved, dilacerated, severely sclerosed or  
obliterated).  
• 
Teeth associated with soft tissue abscess or swelling.  
• 
Teeth with external and internal root resorption  
• 
Re-treatment cases.   
• 
Periodontally compromised teeth (like mobile teeth and teeth with excessive bone loss).  
• 
Teeth requiring endodontic surgery.  
• 
Teeth requiring non-surgical endodontic treatment of multiple teeth in the same or opposing 
quadrant.  
• 
Medically compromised patients (ASA-III and above), patients with special communication 
needs or who doesn’t understand urdu or English language.  
• 
Patients allergic to bee pollen or honey products.  
2.5 - Sample size:  
Sample size was calculated using “Openepi” website, with following configuration:  
• 
90% power of the test  
• 
95% confidence interval (CI)   
• 
With mean and standard deviation (SD) of Calcium hydroxide (2.42 ± 2.1) and Creosote (1.12  
± 0.66) from the article(96).   
The calculated minimum sample size was 62 (31 per group). We intended to increase sample size up to 
30% Hence, final sample size was 80 (40 in each group).  
 
 


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2.6 - Sampling technique:  
Simple Random sampling technique will be used. Random allocation will be generated by computer 
with the help of independent person, not related to the study. Allocation concealment will be done by 
placing the sequence in sealed envelope by the independent person. The envelope will be given to the 
dental assistant not related to the study. After canal preparation is completed, the dental assistant will 
inform the secondary operator about which medicament to be inserted according to the sequence.  
Details about primary operator:  
Primary operator / principal researcher will be responsible for taking the written consent from the 
patients, diagnosis, selection of patients according to inclusion criteria and carrying out the endodontic 
procedure till the root canal preparation was completed. He will be blinded from the type of the 
medicament inserted into the root canal by the secondary operator. The primary operator / principal 
researcher will have an experience of 4 years of post-graduate training in the field of endodontics, with 
a total clinical experience of at least 6 years. The primary operator will also be responsible for; 
explaining the VAS scale to the patient, collecting the scale and data processing.   
Details about secondary operator:  
The secondary operator will be responsible for inserting the medicaments into the root canals after root 
canal preparation wi completed by primary operator. He will have an experience of 4 years of post-
graduate training in the field of endodontics, with a clinical experience of at least 10 years. Additionally, 
the secondary operator will be given the training of mixing and inserting the medicaments into the root 
canals by Principal investigator for a week on a plastic block, resembling canal of a single rooted tooth 
(simulated canal block). The purpose of giving training on a plastic block is that the insertion of the 
medicaments can easily be observed according to its length and density achieved.  
2.7 - Data Collection Procedure:  
Approval from Ethics Review Board will be obtained for this research. Written informed consent will 
be taken from patients.   


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The patients presenting in the Department of Endodontics will be included in the study according to 
inclusion criteria. Detailed medical and dental history will be obtained. Complete extra-oral and 
intraoral examination will be done and periapical radiograph will be taken. Diagnosis of the necrotic 
pulp with symptomatic or asymptomatic apical periodontitis will be made by the combination of history 
of pain, positive vertical percussion test (tender to percussion), Vitality test, periapical radiograph  
(having visible periapical widening or radiolucency) and no bleeding on opening of the pulp chamber.  
The treatment will be performed by the principal researcher till the root canal preparation is completed. 
He will be blinded from the type of medicament being inserted by a secondary independent operator. In 
first visit, anesthesia (2% lidocaine, 1.8 ml with 1:100,000 epinephrine. Medicaine Inj.) will be given, 
rubber dam will be applied and standard infection control protocol will be followed(97). Chamber will 
be opened with a sterilized round bur (ISO 001/014, BR-41. Mani,inc, Japan) and extension and 
refinement will be done with straight fissure bur(ISO 110/014, SF21.Mani,inc. Japan).  After Chamber 
opening, glide path will be formed with ISO k file size 06, 08 and 10(Mani,Inc. Japan). Working length 
will then be taken with apex locator (Dentaport ZX. J Morita MFG Corp, Japan) and confirmed with 
radiograph. The preparation will be carried out till manual 20k hand file. Further canal preparation will 
be done in a crown down manner and rotary endodontic file system (Protaper universal, .04 taper. 
Dentsply Maillefer, Switzerland) will be used with the recommended torque (3.5 N) and speed (300 
rpm). Ethylenediamine tetra acetic acid (EDTA) (GlydeFile prep, Dentsply Maillefer, Switzerland) will 
be used for lubrication and chelation during canal preparation. After each file introduced into the canal, 
irrigation will be done  with 2.5% Sodium hypochlorite with a disposable, open ended, beveled, 27-
guage needle with 5ml syringe kept 2 mm short of working length and solution expressed in a slow 
passive manner. After canal preparation is completed, root canals will be irrigated with 10 ml sterile 
saline solution and then flooded with 17% EDTA solution (MD-Cleanser,Meta Biomed, Korea) for 3 
mins to neutralize sodium hypochlorite. Then, the final rinse of 5 ml saline solution will be carried out 
(98). Canals will be dried with sterile paper points (Dentsply Maillefer, Switzerland) corresponding to 
master apical file.  


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Patients will be randomly divided into 2 groups of 40 patients each, according to the intracanal 
medication inserted. The type of medicament to be placed will be informed to the secondary operator 
by a dental assistant through computer generated sequence, who will insert the assigned intracanal 
medicament. Group I (control [treatment as usual]) will consist of teeth in which Calcium Hydroxide 
paste (Calcipulpe, Septodont. France) will be inserted. In Group II (experimental), 95% propolis powder 
(Henan Fumei Bio-technology Co., Ltd. China reg no.: 411082100010933) mixed with saline in a ratio 
of 1:1.5(wt/vol) to form paste, will be inserted into the root canals. These medicaments will be inserted 
into the canal with lentulo-spiral (Dentsply Maillefer, Switzerland) one size smaller than the master 
apical file, keeping it 1 mm short from the actual working length. Sterilized dry cotton wool will be 
placed in pulp chamber after insertion of medicaments and cavity will be filled with temporary cement 
(Cavit. ESPE Dental AG, Seefeld, Germany). Patient will be given a Visual (pain) analogue scale to 
rate their pain score. Patients will have to mark their intensity of pain preoperatively, then at different 
time intervals; 4 hours, 12 hours, 24 hours(day 2), 48 hours(day 3), 72 hours(day 4). Patients will be 
recalled after 7 days, visual analogue scale will be collected and data will be processed. Obturation and 
core build-up will be done after 7 days.  
2.8 - Study Variables:  
• 
Dependent variable: pain score.  
• 
Independent variable: gender, age, Necrotic teeth with PAI index 3 or greater  
• 
.  
2.9 - Statistical Analysis:  
For data entry and analysis, IBM SPSS version 24 was used. For comparison of the mean pain scores 
between and within both the groups (Control and Experimental), repeated measure anova (mixed way 
anova) will be employed. Additionally, we will treat pain scores of patients taking pain killers (having 
pain scores of 25 or above) as missing values and the same analysis will be done; and a separate table 
will be reported for it. For multiple comparisons between and within groups, post hoc (LSD) test will 
be applied. For each group, descriptive statistics will be reported like mean, SD, minimum and 


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maximum of VAS pain scores. Furthermore, using mean pain scores of these tables, a line chart will be 
used to show the pain score trend with passage of time.   
For comparison of pain score averages between the genders, Mann-Whitney U test will be applied.  
Patients will be divided into four groups according to their ages; 20 to 24, 25 to 29, 30 to 34 and 35 to  
40. For comparison of pain averages among the age groups, Kruskal Wallis test will be applied.  
A p- value of 0.05 or less will be considered as significant and 0.01 or less as highly significant.   
Descriptive statistics like frequencies will be used to report the statistics of: age (with percentages, mean 
age, SD, minimum and maximum); pre-operative pain status of sample; and the percentages of each 
type of single rooted teeth included in the study.   
Similarly, the descriptive statistics like crosstabs will be used to analyze and report; the distribution of 
total number of males and females in each group; distribution of age groups in each group; the 
percentages of type of oral analgesics used by the patients according to different time intervals; the 
severity of pain experienced according to gender at different time intervals; and the severity of pain 
experienced by the patients according to age groups at different time intervals. Furthermore, the crosstab 
will also used to report flare-up rate according to each group. The flare-up will be  determined as having 
pain score difference of 20 or more from previous time interval to the next one.  
  
 
 
 
 
 
 
 
 
 


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CHAPTER 3 : REFERENCES AND APPENDICES:  
3.1 – References:  
1. 
Pak JG, White SN. Pain prevalence and severity before, during, and after root canal treatment: 
a systematic review. J Endod. 2011;37(4):429-38.  
2. 
Gama TG, de Oliveira JCM, Abad EC, Rôças IN, Siqueira Jr JF. Postoperative pain following the 
use of two different intracanal medications. Clin Oral Investig. 2008;12(4):325-30.  
3. 
Sipavičiūtė E MR. Pain and flare-up after endodontic treatment procedures. Stomatologija. 
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24  
  
  
  
97. 
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J Endod. 2015;41(2):169-75.  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
 
 


25  
  
  
  
3.2 – Appendices:  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
     
 
 
 
 
 
 


26  
  
  
  
VISUAL(PAIN) ANALOGUE SCALE  
  
 
  
  
On a scale from 0-100(given above),  please mark the intensity of pain at different times using the 
criteria(chart)  given on the right side:  
  
1) - Before start of treatment =  
2) - 04 hours =  
3) - 12 hours =  
4) - Day 2 =  
5) - Day 3 =  
6) - Day 4 =  
Patient Serial No. =  
  
  
                                                                                                           
                                                                                                        
  
                                                                                       Chart: criteria for assessing the pain severity                                    
                                                                                                                                                                         
 
 
 
0-24=>        No pain to mild pain, 
requires no pain killer.  
25-49=>     Moderate pain  
requires Ibuprofen, or similar 
medication for relief.  
50-74=>     Severe pain not relieved  
by above medication necessitating use of 
narcotic analgesics such as 
Codeincontaining preparations.  
75-100=>  Extreme pain not relieved 
by any measures taken.  
  
  
  


27  
  
  
  
  
 Informed Consent Form  
  
EFFECT OF PROPOLIS PASTE AS INTRACANAL MEDICAMENT   
ON POST-ENDODONTIC PAIN: A DOUBLE BLIND   
RANDOMIZED CLINICAL TRIAL  
  
  
  
  
  
PRINCIPAL RESEARCHER  
  
WITNESS  
  
CONTACT DETAILS  
  
DR. JUZER SHABBIR  
  
  
  
Dr.juzer.shabbir@gmail.com  
  
• 
I consent to participate in the project named above which is taking place in Doctor Ishrat-ul-ibad 
khan Institute of Oral Health Sciences. The particulars of participation have been explained to 
me.  
  
• 
I acknowledge that:   
(a) 
The possible effects of the use of these data have been explained to me to my 
satisfaction  
(b) 
The project is for the purpose of research for assessment in higher education.   
  
• 
I understand that:   
(a) My identity will not be revealed in any report based on this project. (b) This 
consent form and data I supply will be kept in confidence by the researchers.  
  
Information consent (choose one):  YES         NO  
• 
I authorize the researchers to record and analyze data for the stated purposes of the project.   
• 
I have been informed that the confidentiality of the information I provide will  
be safeguarded subject to any legal requirements.   
  
Name  
Age  
  
Sex  
  
Thank you.