Condition category
Oral Health
Date applied
18/06/2017
Date assigned
24/08/2017
Last edited
24/08/2017
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Not yet recruiting

Plain English Summary

Background and study aims
Dental pain is a significant factor that causes patient’s to seek treatment. Non-surgical endodontic (for root canals) treatment is a major therapy to treat the pain and save the tooth. Pain control during this procedure is a challenging goal for dental practitioners. Patients with necrotic teeth (when the centre part of the tooth has decayed) have the highest rates of post-endodontic pain. To prevent this, different techniques have been used. Placing biocompatible (not harmful or toxic) medications with either antimicrobial (anti- bacteria) activity or anti-inflammatory (swelling) component or both inside the root canals is one of the main techniques to disinfect the canals and control the pain. Calcium hydroxide is the most common medicament (medication mixture), however it is ineffective against certain fungi and bacteria, lacks anti-inflammatory component and is controversial in preventing pain. Presently, focus of research has shifted towards natural alternatives that could be used. Propolis is an organic resinous (thick and sticky) substance obtained from bee hive. It is nontoxic, biocompatible, anti-inflammatory, anti-oxidant, and anti-microbial and is effective against certain bacteria and fungi. The aim of this study is to evaluate the effect of Propolis paste on post-endodontic pain in comparison to calcium hydroxide at different time intervals.

Who can participate?
Adults aged 20-40 years old who have a necrotic tooth and require a root canal

What does the study involve?
Participants are randomly allocated to one of two groups. Those in the first group receive endodontic treatment but receive a calcium hydroxide in the root area. Those in the second group receive the Propolis paste in the root area during their endodontic treatment. Participants are followed to and rate their pain levels before surgery and again four, 12, 24, 48 and 72 hours after their treatment. The two different medicaments are compared to see how well they were able to treat pain.

What are the possible benefits and risks of participating?
There are no direct benefits with participating. There are no notable risks however, participants may be allergic to the propolis paste and therefore are not included in the stufy.

Where is the study run from?
1. Dow Dental College (Pakistan)
2. Dr. Ishrat-ul-ibad Khan Institute of Oral Health Sciences (Pakistan)
3. Dow International Dental College (Pakistan)

When is the study starting and how long is it expected to run for?
January 2017 to October 2018

Who is funding the study?
Investigator initiated and funded (Pakistan)

Who is the main contact?
Dr Juzer Shabbir

Trial website

Contact information

Type

Scientific

Primary contact

Dr Juzer Shabbir

ORCID ID

Contact details

Dow University of Health Sciences
Dr. Ishrat-ul-ibad Khan Institute of Oral Health Sciences
Gulzar-e-Hijri
Ojha Campus
SUPARCO road
KDA Scheme-33
Karachi
75270
Pakistan

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

SMB53

Study information

Scientific title

Effect of Propolis paste as compared to Calcium hydroxide when used as an intracanal medicament in necrotic teeth on post-endodontic pain: A double-blind randomized clinical trial

Acronym

Study hypothesis

Null hypothesis:
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.

Ethics approval

Not provided at time of registration.

Study design

Parallel group prospective double blind randomized controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Prevention

Patient information sheet

No participant information sheet available

Condition

Domain in healthcare is dentistry and the condition we will be studying is Necrotic teeth with symptomatic apical periodontitis

Intervention

Control group: Calcium hydroxide
Intervention group: Propolis paste
Non-probability sampling will be done for sample recruitment and simple randomization for group allocation. Random group allocation will be computer generated. with equal randomization (1:1). The patients and the principal researcher will be blinded from the type of intracanal medicament inserted.

Patient attending the diagnosis department of the hospital with complaint of pain and having necrotic teeth found on examination, requiring standard non-surgical endodontic treatment are selected by non probability sampling for the study with his/her consent. Participants are randomly allocated to one of two groups by computer generated simple randomisation.

Group 1 (Control group): In the 1st visit of non surgical endodontic therapy, the standard procedure is performed until root canal preparation is completed. Then participants receive calcium hydroxide as an intracanal medicament inserted in the canal. This is supplied in a paste like consistency by the manufacturer and approximately 2.5 mg of the medication is used in each canal. This is inserted with the help of lentulo-spirals. They are only inserted once and then temporary fillings are done inside the tooth.

Group 2 (Intervention group): In the 1st visit of non surgical endodontic therapy, the standard procedure is performed until root canal preparation is completed. Then participants receive Propolis paste as an intracanal medicament inserted in the canal. Propolis paste is made by mixing 1.5 mg of propolis powder with 1 ml of normal saline and then is inserted into the root canal. This is inserted with the help of lentulo-spirals. They are only inserted once and then temporary fillings are done inside the tooth.

Participants are followed up after their first visit to mark their pain intensity (score) pre-operatively, then at four hours, 12 hours, 24 hours, 48 hours and 72 hours. Participants are then recalled after a week, and their pains scores are collected and their medicaments are removed and they proceed with their standard endodontic treatment.

Intervention type

Drug

Phase

Phase III

Drug names

Propolis paste

Primary outcome measures

1. Pain score is recorded by the patient using the Visual Analogue Scale (VAS scale) at four, 12, 24, 48 and 72 hours
2. Number of patients reaching the full followup period without taking oral analgesic is measured using the Visual Analogue Scale (statistically analysed during processing (after VAS scales are collected from all of the patients) to know how many patients reached the full follow up period of 72 hours without taking any oral analgesic) at 72 hours

Secondary outcome measures

Types of oral analgesic is measured using VAS scale (which is based on oral analgesics prescribed according to differing intensities of pain) and evaluating what type of analgesics are taken the most in each group at 72 hours

Overall trial start date

01/01/2017

Overall trial end date

31/10/2018

Reason abandoned

Eligibility

Participant inclusion criteria

1. Aged 20-40 years
2. Both male and female both
3. Single rooted Necrotic teeth with symptomatic periapical periodontitis having visible periapical widening or radiolucency without bone expansion (PAI index 3 and 4)
4. Teeth with favorable root morphology
5. Teeth with closed apex

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

80 patients attending the dental OPD with complain of pain, having necrotic single rooted teeth requiring non surgical endodontic treatment

Participant exclusion criteria

1. Teeth with PAI index 1, 4 and 5
2. Patients who are on antibiotics
3. Patient with recent trauma to the jaw
4. Teeth with open apex
5. Multi-rooted teeth
6. Vital teeth
7. Non-restorable teeth
8. Unfavorable root morphology (severely curved, dilacerated, severely sclerosed or obliterated)
9. Teeth associated with soft tissue abscess or swelling
10. Teeth with external and internal root resorption
11. Re-treatment cases
12. Periodontally compromised teeth (like mobile teeth and teeth with excessive bone loss)
13. Teeth requiring endodontic surgery
14. Teeth requiring non-surgical endodontic treatment of multiple teeth in the same or opposing quadrant
15. Medically compromised patients (ASA-III and above), patients with special communication needs or who doesn’t understand urdu or English language
16. Patients allergic to bee pollen or honey products

Recruitment start date

01/10/2017

Recruitment end date

31/07/2018

Locations

Countries of recruitment

Pakistan

Trial participating centre

Dow Dental College
Dow University of Health Sciences Baba-E-Urdu Road
Karachi
74200
Pakistan

Trial participating centre

Dr. Ishrat-ul-ibad Khan Institute of Oral Health Sciences
Ojha campus University Road
Karachi
74200
Pakistan

Trial participating centre

Dow International Dental College
Korangi Road
Karachi
74200
Pakistan

Sponsor information

Organisation

Dow University of Health Sciences

Sponsor details

Dow University of Health Sciences
Baba-E-Urdu Road
Karachi
74200
Pakistan

Sponsor type

University/education

Website

http://www.duhs.edu.pk/

Funders

Funder type

Not defined

Funder name

Investigator initiated and funded

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Planned publication in a high impact peer reviewed journal.

IPD sharing statement:
The current data sharing plans for the current study are unknown and will be made available at a later date.

Intention to publish date

31/10/2019

Participant level data

To be made available at a later date

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes