Post-Operative Pain, ChronicNCT04983524
Propolis Versus Calcium Hydroxide on Post-Operative Pain in Patients With Necrotic Pulp
A study testing propolis and Calcium Hydroxide in people with Post-Operative Pain, Chronic and Necrotic Pulp, run by Cairo University.
Trial summary
Propolis is a resinous product of honeybees. Propolis is said to be effective against resistant microorganisms inside the root canal compared to the gold standard medication known as calcium hydroxide. The clinical trial tests the effect of propolis versus calcium hydroxide on pain in patients with necrotic teeth. Read more about this study
- Who is it for?
- Ages 20 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Post-Operative Pain, Chronic, Necrotic Pulp
- What is being tested?
- propolis and Calcium Hydroxide
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- No sites listed yet
- Study dates
- Oct 2015to May 2018
- Phase
- Interventional
- 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 20 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- • Asymptomatic patients with age range 20 - 40 years
- Necrotic, single canal maxillary and mandibular teeth with periapical infection presented as radiolucency or widening in the periodontal membrane space.
- Medically - free of any systemic disease
- Teeth with complete root formation
Who cannot join
- • Pregnant or lactating females
- Teeth with vital pulps, internal or external resorption or anatomic abnormalities
- Teeth with cracks, curvatures, root caries and calcified canals
- Double or triple-rooted teeth
- Patients with facial swelling, acute pulpal or periapical lesion
- Teeth that are not indicated for endodontic treatment: Bad oral hygiene, mobile or recessed
- Previously endodontically-treated teeth
About this study
Official title: Evaluation of the Effect of Propolis Versus Calcium Hydroxide, Intracanal Medicaments on Post-Operative Pain in Patients With Necrotic Pulp (A Randomized Clinical Trial)
Propolis is a resinous product of honeybees. Propolis is said to be effective against resistant microorganisms inside the root canal compared to the gold standard medication known as calcium hydroxide. The clinical trial tests the effect of propolis versus calcium hydroxide on pain in patients with necrotic teeth.
Read the detailed description
Propolis is an immunomodulatory, antioxidant, flavonoid-rich resinous product of honeybees. Propolis was reported as less cytotoxic and more effective against resistant microorganisms than calcium hydroxide as well as biocompatible to the periradicular tissues than existing intracanal medicaments. The aim of this single-blinded randomized clinical trial was to evaluate the effect of propolis versus calcium hydroxide, intracanal medicaments, on post-operative pain in patients with necrotic single canal teeth. Methods: Forty-six participants with an age range of 20-40 years old, diagnosed as having necrotic pulp in their single-rooted, single canal teeth were included in this study, with 23 participants in each group. Treatment was done in two visits and intracanal medicament was applied for one week in between. Participants were instructed to rate their pain score by a numerical rating scale after 24, 48, 72 hours and at 7 days.
- Conditions
- Post-Operative Pain, Chronic, Necrotic Pulp
- Being tested
- propolis, Calcium Hydroxide
- Keywords
- calcium hydroxide, propolis, post-operative pain, necrotic pulp
- Medical subject headings
- Pain, Postoperative, Dental Pulp Necrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
propolisDietary supplement
resinous product of honeybees
Calcium HydroxideDrug
Gold standard control intracanal medicament
| Study group | Role | What they receive |
|---|---|---|
| Propolis | Experimental | intervention intracanal medicament Receives: Dietary Supplement: propolis |
| Calcium Hudroxide | Active comparator | Gold standard intracanal medicament Receives: Drug: Calcium Hydroxide |
What is being measured
The primary outcome is the main question the study is designed to answer.
post-operative pain
Categorical data on numerical rating scale
Measured: one week. line of 10 points
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2021
- Study startOct 2015
- Primary completionMay 2018
- Study completionMay 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post-Operative Pain, ChronicStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Serene Mohamed Hisham Sirry, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04983524
- Sponsor's protocol ID
- SSirry
- Status last verified
- Jul 2021
- First submitted
- 11 Jul 2021
- Last updated
- 30 Jul 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: the study protocol can be shared.
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effect of Propolis Versus Calcium Hydroxide, Intracanal Medicaments on Post-Operative Pain in Patients With Necrotic Pulp (A Randomized Clinical Trial)
- ClinicalTrials.gov ID
- NCT04983524
- Acronym / sponsor ID
- SSirry
- Conditions
- Post-Operative Pain, Chronic, Necrotic Pulp
- Keywords
- calcium hydroxide, propolis, post-operative pain, necrotic pulp
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- Oct 2015 (actual)
- Primary completion
- May 2018 (actual)
- Study completion
- May 2018 (actual)
- First posted
- 30 Jul 2021 (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.
Propolis is a resinous product of honeybees. Propolis is said to be effective against resistant microorganisms inside the root canal compared to the gold standard medication known as calcium hydroxide. The clinical trial tests the effect of propolis versus calcium hydroxide on pain in patients with necrotic teeth.
Detailed description
Propolis is an immunomodulatory, antioxidant, flavonoid-rich resinous product of honeybees. Propolis was reported as less cytotoxic and more effective against resistant microorganisms than calcium hydroxide as well as biocompatible to the periradicular tissues than existing intracanal medicaments. The aim of this single-blinded randomized clinical trial was to evaluate the effect of propolis versus calcium hydroxide, intracanal medicaments, on post-operative pain in patients with necrotic single canal teeth. Methods: Forty-six participants with an age range of 20-40 years old, diagnosed as having necrotic pulp in their single-rooted, single canal teeth were included in this study, with 23 participants in each group. Treatment was done in two visits and intracanal medicament was applied for one week in between. Participants were instructed to rate their pain score by a numerical rating scale after 24, 48, 72 hours and at 7 days.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Propolis | Experimental | Dietary Supplement: propolisintervention intracanal medicament |
| Calcium Hudroxide | Active comparator | Drug: Calcium HydroxideGold standard intracanal medicament |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- • Asymptomatic patients with age range 20 - 40 years
Key exclusion criteria (7 listed)
- • Pregnant or lactating females
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 |
|---|---|---|
| propolisresinous product of honeybees | Dietary supplement | Propolis |
| Calcium HydroxideGold standard control intracanal medicament | Drug | Calcium Hudroxide |
Primary outcome
post-operative pain
Time frame: one week. line of 10 points
Categorical data on numerical rating scale
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 30 Jul 2021.
- Individual participant dataSharing planned: Yes. the study protocol can be shared.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing propolis and Calcium Hydroxide in people with Post-Operative Pain, Chronic and Necrotic Pulp, run by Cairo University.
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 4 inclusion and 7 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 30 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
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.
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?
post-operative pain (time frame: one week. line of 10 points). 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 30 Jul 2021.