Pain, PostoperativePhase 3NCT03723980
Role of Propolis Paste in Preventing Pain After Root Canal Treatment.
A Phase 3 study testing Propolis and Calcium Hydroxide in people with Pain, Postoperative, run by Juzer Shabbir Saifee at 1 site in Pakistan.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Pain, Postoperative
- What is being tested?
- Propolis and Calcium Hydroxide
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 sitePakistan
- Study dates
- 16 Nov 2017to 15 Oct 2018
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Single rooted Necrotic teeth with symptomatic or asymptomatic periapical periodontitis having periapical widening or radiolucency without bone expansion (PAI index 2, 3 and 4).
- Teeth with favorable root morphology.
- Teeth with closed apex.
Who cannot join
- Teeth with PAI index 1 and 5.
- Patients who are on antibiotics.
- Patient with recent trauma to the jaw.
- Teeth with open apex
- Multi-rooted teeth.
- Vital teeth.
Show all 16Show fewer
- Non-restorable teeth.
- Unfavorable root morphology (severely curved, dilacerated, severely sclerosed or obliterated).
- Teeth associated with soft tissue abscess or swelling.
- Teeth with external or 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Propolis Paste as Intracanal Medicament on Post-Endodontic Pain: a Double-Blind Randomized Clinical Trial.
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.
Read the 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
- Conditions
- Pain, Postoperative
- Being tested
- Propolis, Calcium Hydroxide
- Keywords
- Flare up
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PropolisDrug
Also called Bee glue
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.
Calcium HydroxideDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Control Group or Group I or Calcium hydroxide Group | Active comparator | Not described Receives: Drug: Calcium Hydroxide |
| Experimental Group or Group II or Propolis Group | Experimental | Not described Receives: Drug: Propolis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain Intensity Measure: Visual Analogue Pain Scale
Self recorded pain intensity by the patients at 4 hours, 12 hours, day 2, day 3 and day 4 after root canal preparation and intracanal medicament insertion (first visit). Pain intensity recorded on a Visual Analogue Scale from 0 to 100. Patients who experience no or mild pain; and do not require analgesic will record their pain intensity from 0 to 24. Patients who experience moderate pain; and require Over-the-counter analgesic will record pain intensity from 25 to 49. Patients who experience severe pain; and require use of codeine containing medicine will record their pain intensity from 50 to 74. Patients who experience extreme pain, and no medicine is able to relieve their pain will record pain intensity from 75 to 100.
lower pain score (intensity) is a better outcome as compared to higher pain intensity (score)
Measured: 4 hours, 12 hours, day 2, day 3 and day 4
Secondary outcomes (2)
Acute Increase in Pain Score (Acute Exacerbation of Pain)
An increase of 20 or more points on Visual Analogue Pain Scale from pain score of previous time interval
Information about the Visual Analogue Scale:
- it consists of pain score from 0 to 100.
- The higher the pain score; the worse the pain
- An increase of a total of at least 20 pain score points from previous pain score reading indicate that pain has increased significantly and will be reported as "flare-up"
Measured: 4 hours, 12 hours, day 2, day 3, and day 4
Difference of Pain Score Between Different Time Intervals
Visual Analogue Pain Score information:
- pain intensity is measured with this scale
- minimum pain score reading on Visual Analogue Scale is 0 and Maximum is 100
- higher values represent worse pain and lower values represent lesser pain this pain score is recorded pre-operatively, then at time intervals of 4 hours, 12 hours, day 2, day 3 and day 4. the comparison of mean pain scores of different time intervals will be made.
Measured: 4 hours, 12 hours, day 2, day 3, and day 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2018
- Study start16 Nov 2017
- Primary completion24 Apr 2018
- Study completion15 Oct 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Pain, PostoperativeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Juzer Shabbir Saifee
- Sponsor type
- University, hospital or other
- Collaborators
- Dow University of Health Sciences
- Responsible party
- Sponsor-investigator, Juzer Shabbir Saifee, Dow University of Health Sciences
- Investigators
- Juzer S Saifee, Principal investigator, Dow University of Health SciencesFazal R Qazi, Study director, Dow University of Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03723980
- Sponsor's protocol ID
- MDSJUZER
- Other IDs
- ISRCTN66816132
- Status last verified
- Mar 2019
- First submitted
- 23 Oct 2018
- Last updated
- 6 Jun 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 6 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Propolis Paste as Intracanal Medicament on Post-Endodontic Pain: a Double-Blind Randomized Clinical Trial.
- ClinicalTrials.gov ID
- NCT03723980
- Acronym / sponsor ID
- MDSJUZER
- Conditions
- Pain, Postoperative
- Keywords
- Flare up
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Juzer Shabbir SaifeeUniversity, hospital or other
- Collaborators
- Dow University of Health Sciences
- Study start
- 16 Nov 2017 (actual)
- Primary completion
- 24 Apr 2018 (actual)
- Study completion
- 15 Oct 2018 (actual)
- First posted
- 30 Oct 2018 (actual)
- Results
- Posted 6 Jun 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control Group or Group I or Calcium hydroxide Group | Active comparator | Drug: Calcium Hydroxide |
| Experimental Group or Group II or Propolis Group | Experimental | Drug: Propolis |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Single rooted Necrotic teeth with symptomatic or asymptomatic periapical periodontitis having periapical widening or radiolucency without bone expansion (PAI index 2, 3 and 4).
- Teeth with favorable root morphology.
- Teeth with closed apex.
Key exclusion criteria (16 listed)
- Teeth with PAI index 1 and 5.
- Patients who are on antibiotics.
- Patient with recent trauma to the jaw.
- Teeth with open apex
- Multi-rooted teeth.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PropolisAlso: Bee glueit 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. | Drug | Experimental Group or Group II or Propolis Group |
| Calcium Hydroxideit 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. | Drug | Control Group or Group I or Calcium hydroxide Group |
Primary outcome
Pain Intensity Measure: Visual Analogue Pain Scale
Time frame: 4 hours, 12 hours, day 2, day 3 and day 4
Self recorded pain intensity by the patients at 4 hours, 12 hours, day 2, day 3 and day 4 after root canal preparation and intracanal medicament insertion (first visit). Pain intensity recorded on a Visual Analogue Scale from 0 to 100. Patients who experience no or mild pain; and do not require analgesic will record their pain intensity from 0 to 24. Patients who experience moderate pain; and require Over-the-counter analgesic will record pain intensity from 25 to 49. Patients who experience severe pain; and require use of codeine containing medicine will record their pain intensity from 50 to 74. Patients who experience extreme pain, and no medicine is able to relieve their pain will record pain intensity from 75 to 100. lower pain score (intensity) is a better outcome as compared to higher pain intensity (score)
2 secondary outcomes
Acute Increase in Pain Score (Acute Exacerbation of Pain)
Time frame: 4 hours, 12 hours, day 2, day 3, and day 4
Difference of Pain Score Between Different Time Intervals
Time frame: 4 hours, 12 hours, day 2, day 3, and day 4
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jun 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Juzer S Saifee principal investigator
Dow University of Health Sciences
Fazal R Qazi study director
Dow University of Health Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Propolis and Calcium Hydroxide in people with Pain, Postoperative, run by Juzer Shabbir Saifee at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 6 Jun 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain Intensity Measure: Visual Analogue Pain Scale (time frame: 4 hours, 12 hours, day 2, day 3 and day 4). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jun 2019.