Post-operative PainPhase 3NCT05974748
Role of Propolis Endodontic Irrigant on Post-Operative Pain
A Phase 3 study testing Sodium hypochlorite 5.25% and Propolis 20% in people with Post-operative Pain and Symptomatic Irreversible Pulpitis, run by Dow University of Health Sciences at 1 site in Pakistan.
Trial summary
The goal of this clinical trial is to compare propolis and sodium hypochlorite as endodontic irrigants in patients presenting with symptomatic irreversible pulpitis. . The main question it aims to answer is: if there is any analgesic effects of 20% Propolis compared with 5.25% NaOCl on the intensity of post-operative… Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Post-operative Pain, Symptomatic Irreversible Pulpitis
- What is being tested?
- Sodium hypochlorite 5.25% and Propolis 20%
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Apr 2023to 15 Aug 2023
- Phase
- Phase 3
- Are there results?
- None posted in the registry
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 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- ASA-I and II individuals who are between the ages of 18 and 60 years.
- Patients with mandibular and maxillary premolars who have been diagnosed with symptomatic irreversible pulpitis (with either a normal periapex or symptomatic apical periodontitis).
- Patients who score moderate to severe (4-10) on a preoperative visual analogue scale (VAS=1-10)
Who cannot join
- Patients suffering from severe pain because of traumatic occlusion.
- Teeth with extensive damage, calcified canals, periapical radiolucency, root resorption, and an open apex.
- Patients with compromised medical condition (ASA-III and above)
- Patients who are unable to communicate effectively in either Urdu or English.
- Pregnant and lactating ladies
- Patients who are allergic to honey or bee pollen.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparative Evaluation of Propolis and Sodium Hypochlorite as Endodontic Irrigants on Post-Operative Pain in Patients With Symptomatic Irreversible Pulpitis
The goal of this clinical trial is to compare propolis and sodium hypochlorite as endodontic irrigants in patients presenting with symptomatic irreversible pulpitis.
. The main question it aims to answer is:
Read more
- if there is any analgesic effects of 20% Propolis compared with 5.25% NaOCl on the intensity of post-operative pain in patients with symptomatic irreversible pulpitis using VAS pain score. Participants will undergo root canal treatment of their teeth using either 20% propolis solution or 5.25% NaOCl in their first visit of a multi-visit root canal treatment.
Researchers will compare 20% Propolis and 5.25% NaOCl to see reduction in Intensity of Post-Operative Pain using visual analogue scale over 72 hour duration.
Read the detailed description
Sodium hypochlorite as an endodontic irrigant, poses problems of toxicity. Additionally, its unfavorable odor, taste, failure to remove the smear layer, and proteolytic effect have deleterious effects on the dentine, creating unfavorable structural and mechanical alterations . To get beyond NaOCl limits and adverse effects, it is necessary to look for a biocompatible, equally effective, and dentine friendly irrigant with greater patient acceptance in taste and odor.
The literature lacks an in-vivo study that investigates the anti-inflammatory with analgesic characteristics of Propolis on post-endodontic pain as an irrigant, in patients with symptomatic irreversible pulpitis. This research will endeavor to fill this gap in literature.
- Being tested
- Sodium hypochlorite 5.25%, Propolis 20%
- Keywords
- Propolis, Endodontic Irrigant
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sodium hypochlorite 5.25%Drug
Also called NaOCl
The participants will be randomly divided into two groups using the sealed envelope method during the instrumentation process. The clinician will use the irrigation in accordance with the protocol. Between each instrument in group A, 3 ml of 5.25% sodium hypochlorite (NaOCl) will be used to irrigate each canal.
Propolis 20%Drug
Also called Bee glue
In group B, a 20% hydroalcoholic propolis solution of 3 milliliters will be used to irrigate each canal, between each instrument.
| Study group | Role | What they receive |
|---|---|---|
| Sodium Hypochlorite | Active comparator | 5.25% sodium hypochlorite is the gold standard endodontic irrigant. Other Name: NaOCl Receives: Drug: Sodium hypochlorite 5.25% |
| Propolis | Experimental | Hydroalcoholic 20% propolis will be used as an endodontic irrigant. Other Name: Bee glue Receives: Drug: Propolis 20% |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in post-operative pain intensity on visual analogue scale(0-10)
Self recorded by patient and then assessed by an intern on a visual analogue scale of 0-10 with 0 being no pain , 10 being worst pain
Measured: 24 hours, 48 hours and 72 hours
Secondary outcomes (1)
Need of rescue medicine in both groups
Self recorded by patient and then assessed by an intern on a visual analogue scale of 0-10 with 0 being no pain , 10 being worst pain
Measured: within first 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2023
- Study start1 Apr 2023
- Primary completion15 Aug 2023
- Study completion15 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post-operative PainStudies 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
- Model description
- 2 interventional groups assigned. 1 will be receiving routine intervention and other is the experimental group.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dow University of Health Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tayyaba Tahira, Dow University of Health Sciences
- Investigators
- Tayyaba Tahira, BDS FCPS, Principal investigator, Dow International Dental College, Dow University of Health SciencesFarah Naz, BDS FCPS, Study director, Dow International Dental College, Dow University of Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05974748
- Sponsor's protocol ID
- 2908
- Status last verified
- Sep 2023
- First submitted
- 16 Jul 2023
- Last updated
- 7 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Only investigators and co-investigators of this study will be able to access to participants' personal data. Ownership of the data will remain with the principal investigator and Department of Operative Dentistry, Dow International Dental College(DIDC) , Dow University of Health Sciences
Study at a glance
From the registry record, last updated by the sponsor on 7 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Evaluation of Propolis and Sodium Hypochlorite as Endodontic Irrigants on Post-Operative Pain in Patients With Symptomatic Irreversible Pulpitis
- ClinicalTrials.gov ID
- NCT05974748
- Acronym / sponsor ID
- 2908
- Keywords
- Propolis, Endodontic Irrigant
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Dow University of Health SciencesUniversity, hospital or other
- Study start
- 1 Apr 2023 (actual)
- Primary completion
- 15 Aug 2023 (actual)
- Study completion
- 15 Aug 2023 (actual)
- First posted
- 3 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this clinical trial is to compare propolis and sodium hypochlorite as endodontic irrigants in patients presenting with symptomatic irreversible pulpitis.
. The main question it aims to answer is:
- if there is any analgesic effects of 20% Propolis compared with 5.25% NaOCl on the intensity of post-operative pain in patients with symptomatic irreversible pulpitis using VAS pain score. Participants will undergo root canal treatment of their teeth using either 20% propolis solution or 5.25% NaOCl in their first visit of a multi-visit root canal treatment.
Researchers will compare 20% Propolis and 5.25% NaOCl to see reduction in Intensity of Post-Operative Pain using visual analogue scale over 72 hour duration.
Detailed description
Sodium hypochlorite as an endodontic irrigant, poses problems of toxicity. Additionally, its unfavorable odor, taste, failure to remove the smear layer, and proteolytic effect have deleterious effects on the dentine, creating unfavorable structural and mechanical alterations . To get beyond NaOCl limits and adverse effects, it is necessary to look for a biocompatible, equally effective, and dentine friendly irrigant with greater patient acceptance in taste and odor.
The literature lacks an in-vivo study that investigates the anti-inflammatory with analgesic characteristics of Propolis on post-endodontic pain as an irrigant, in patients with symptomatic irreversible pulpitis. This research will endeavor to fill this gap in literature.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- 2 interventional groups assigned. 1 will be receiving routine intervention and other is the experimental group.
| Arm | Type | Receives |
|---|---|---|
| Sodium Hypochlorite | Active comparator | Drug: Sodium hypochlorite 5.25%5.25% sodium hypochlorite is the gold standard endodontic irrigant. Other Name: NaOCl |
| Propolis | Experimental | Drug: Propolis 20%Hydroalcoholic 20% propolis will be used as an endodontic irrigant. Other Name: Bee glue |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- ASA-I and II individuals who are between the ages of 18 and 60 years.
- Patients with mandibular and maxillary premolars who have been diagnosed with symptomatic irreversible pulpitis (with either a normal periapex or symptomatic apical periodontitis).
- Patients who score moderate to severe (4-10) on a preoperative visual analogue scale (VAS=1-10)
Key exclusion criteria (6 listed)
- Patients suffering from severe pain because of traumatic occlusion.
- Teeth with extensive damage, calcified canals, periapical radiolucency, root resorption, and an open apex.
- Patients with compromised medical condition (ASA-III and above)
- Patients who are unable to communicate effectively in either Urdu or English.
- Pregnant and lactating ladies
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 |
|---|---|---|
| Sodium hypochlorite 5.25%Also: NaOClThe participants will be randomly divided into two groups using the sealed envelope method during the instrumentation process. The clinician will use the irrigation in accordance with the protocol. Between each instrument in group A, 3 ml of 5.25% sodium hypochlorite (NaOCl) will be used to irrigate each canal. | Drug | Sodium Hypochlorite |
| Propolis 20%Also: Bee glueIn group B, a 20% hydroalcoholic propolis solution of 3 milliliters will be used to irrigate each canal, between each instrument. | Drug | Propolis |
Primary outcome
Change in post-operative pain intensity on visual analogue scale(0-10)
Time frame: 24 hours, 48 hours and 72 hours
Self recorded by patient and then assessed by an intern on a visual analogue scale of 0-10 with 0 being no pain , 10 being worst pain
1 secondary outcome
Need of rescue medicine in both groups
Time frame: within first 24 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Sep 2023.
- Individual participant dataSharing planned: No. Only investigators and co-investigators of this study will be able to access to participants' personal data. Ownership of the data will remain with the principal investigator and Department of Operative Dentistry, Dow International Dental College(DIDC) , Dow University of Health Sciences
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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.
Tayyaba Tahira, BDS FCPS principal investigator
Dow International Dental College, Dow University of Health Sciences
Farah Naz, BDS FCPS study director
Dow International Dental College, 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 Sodium hypochlorite 5.25% and Propolis 20% in people with Post-operative Pain and Symptomatic Irreversible Pulpitis, run by Dow University of Health Sciences 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 6 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 7 Sep 2023. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Change in post-operative pain intensity on visual analogue scale(0-10) (time frame: 24 hours, 48 hours and 72 hours). 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 7 Sep 2023.