Postoperative PainNCT07578311
Effect of a Herbal Intracanal Medication On Postoperative Pain And Flare up Incidence In Non Surgical Root Canal Retreatment
A study testing Calcium hydroxide, Propolis Extract and Green Tea Polyphenolics (EGCG) in people with Postoperative Pain and Flare Up, Symptom, run by Minia University.
Trial summary
The primary objective of this randomized clinical trial is to evaluate and compare the effectiveness of two natural, herbal-based intracanal medications-Propolis and Green Tea Polyphenolics (EGCG)-against the conventional Calcium Hydroxide in reducing postoperative pain and the incidence of flare-ups during… Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Postoperative Pain, Flare Up, Symptom, Flare up
- What is being tested?
- Calcium hydroxide, Propolis Extract and Green Tea Polyphenolics (EGCG)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- Jul 2026to Feb 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Failed previously performed endodontic treatment of single-rooted teeth.
- Presence of a periapical lesion ranging from 1 mm to 2 mm in diameter.
- Teeth with complete root formation.
- Teeth without evidence of external or internal root resorption.
Who cannot join
- Pregnant females.
- Patients with uncontrolled systemic diseases.
- Patients currently under antibiotic or analgesic administration.
- Patients presenting with facial swelling.
- Teeth not indicated for endodontic retreatment (e.g., poor oral hygiene, mobile teeth, or recessed teeth).
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Effect Of Phytotherapeutics As Intracanal Medication On Postoperative Pain And Flare up Incidence In Non Surgical Root Canal Retreatment. (Randomized Clinical Trial)
The primary objective of this randomized clinical trial is to evaluate and compare the effectiveness of two natural, herbal-based intracanal medications-Propolis and Green Tea Polyphenolics (EGCG)-against the conventional Calcium Hydroxide in reducing postoperative pain and the incidence of flare-ups during non-surgical root canal retreatment.
Postoperative pain is a common complication in endodontics, particularly in retreatment cases where complex bacterial environments and procedural challenges increase the risk of discomfort and acute flare-ups. While Calcium Hydroxide is the traditional gold standard due to its antimicrobial properties, natural phytotherapeutics like Propolis and Green Tea are being investigated for their potent anti-inflammatory, antioxidant, and antibacterial benefits, which may offer superior biocompatibility and symptomatic relief.
Read more
Forty patients requiring endodontic retreatment of single-rooted teeth will be randomly assigned to one of three groups:
Group I (Control): Receives Calcium Hydroxide paste.
Group II: Receives Propolis-based medication.
Group III: Receives Green Tea Polyphenolic-based medication.
The study follows a two-visit protocol. During the first visit, the previous root canal filling is removed, the canal is cleaned and shaped, and the assigned medication is placed. Postoperative pain will be assessed using a Visual Analog Scale (VAS) at 6, 12, 24, 48, 72 hours, and 7 days. Flare-up incidence (sudden severe pain or swelling) will also be monitored. In the second visit, the medication is removed, and the canal is permanently sealed using a bioceramic sealer and gutta-percha. The results will help determine if these herbal alternatives can provide a more comfortable treatment experience for patients undergoing root canal retreatment.
- Conditions
- Postoperative Pain, Flare Up, Symptom, Flare up
- Being tested
- Calcium hydroxide, Propolis Extract, Green Tea Polyphenolics (EGCG)
- Keywords
- postoperative pain, flare up, intra-canal medication, calcium hydroxide, propolis, Green Tea Polyphenolics
- Medical subject headings
- Pain, Postoperative, Symptom Flare Up
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Calcium hydroxideDrug
Following chemo-mechanical preparation and canal drying, Calcium Hydroxide paste is inserted into the root canal using a specialized syringe. The material is placed 0.5-1 mm from the apex to ensure complete filling without extrusion. It remains in the canal until the second visit for obturation.
Propolis ExtractDrug
After cleaning, shaping, and drying the root canal, a Propolis-based natural resinous substance is used as an intracanal medication. The material is delivered via syringe to a depth of 0.5-1 mm from the apex. This herbal medicament is utilized for its antimicrobial and anti-inflammatory properties.
Green Tea Polyphenolics (EGCG)Drug
Following the standardized cleaning protocol and canal drying, Green Tea Polyphenolics (EGCG) extract is inserted as an intracanal medication. The extract is placed 0.5-1 mm from the apex using a syringe. It serves as an herbal antioxidant and antimicrobial agent during the inter-appointment period.
| Study group | Role | What they receive |
|---|---|---|
| Calcium Hydroxide Group | Active comparator | Patients receiving conventional Calcium Hydroxide paste as an intracanal medication. Receives: Drug: Calcium hydroxide |
| Propolis Group | Experimental | Patients receiving a Propolis-based herbal extract as an intracanal medication Receives: Drug: Propolis Extract |
| Green Tea Group | Experimental | Patients receiving Green Tea Polyphenolics (EGCG) as an intracanal medication. Receives: Drug: Green Tea Polyphenolics (EGCG) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative pain
Postoperative pain is to be assessed using visual analog scale (VAS), A scale from (0 to 10) where "0" means no pain and "10" means a severe pain that has never faced before.
Patients will be contacted by phone at 6, 12, 24, 48, 72 hours and 7 days after the first visit to collect the postoperative pain data.
Measured: 6, 12, 24, 48, 72 hours and 7 days after the first visit to collect the postoperative pain data.
Flare-Up Incidence
Flare-up is assessed through asking the patient to notify the investigator if any sudden severe pain or swelling takes place.
This could require an unscheduled emergency visit or prescription of additional medication.
Measured: Within 7 days post-treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2026
- Study startJul 2026 (estimated)
- Primary completionJan 2027 (estimated)
- Study completionFeb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative PainStudies of the same condition, open and under way.
- More trials run by Minia 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- participants will be randomly assigned to one of three parallel groups. each group will receive a different intracanal medicament following non surgical root canal retreatment. post operative pain and flare up incidence will be assessed and compared between the three groups.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Minia University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Abdulla Aiman Ghanemah, Minia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07578311
- Sponsor's protocol ID
- EC-MU Research No.1254
- Status last verified
- May 2026
- First submitted
- 5 May 2026
- Last updated
- 11 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual Participant Data (IPD) will not be shared due to privacy concerns and the limited scope of data use approved by the ethics committee. The study is designed for internal analysis only and does not include provisions for public data sharing
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect Of Phytotherapeutics As Intracanal Medication On Postoperative Pain And Flare up Incidence In Non Surgical Root Canal Retreatment. (Randomized Clinical Trial)
- ClinicalTrials.gov ID
- NCT07578311
- Acronym / sponsor ID
- EC-MU Research No.1254
- Conditions
- Postoperative Pain, Flare Up, Symptom, Flare up
- Keywords
- postoperative pain, flare up, intra-canal medication, calcium hydroxide, propolis, Green Tea Polyphenolics
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Minia UniversityUniversity, hospital or other
- Study start
- Jul 2026 (estimated)
- Primary completion
- Jan 2027 (estimated)
- Study completion
- Feb 2027 (estimated)
- First posted
- 11 May 2026 (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 primary objective of this randomized clinical trial is to evaluate and compare the effectiveness of two natural, herbal-based intracanal medications-Propolis and Green Tea Polyphenolics (EGCG)-against the conventional Calcium Hydroxide in reducing postoperative pain and the incidence of flare-ups during non-surgical root canal retreatment.
Postoperative pain is a common complication in endodontics, particularly in retreatment cases where complex bacterial environments and procedural challenges increase the risk of discomfort and acute flare-ups. While Calcium Hydroxide is the traditional gold standard due to its antimicrobial properties, natural phytotherapeutics like Propolis and Green Tea are being investigated for their potent anti-inflammatory, antioxidant, and antibacterial benefits, which may offer superior biocompatibility and symptomatic relief.
Forty patients requiring endodontic retreatment of single-rooted teeth will be randomly assigned to one of three groups:
Group I (Control): Receives Calcium Hydroxide paste.
Group II: Receives Propolis-based medication.
Group III: Receives Green Tea Polyphenolic-based medication.
The study follows a two-visit protocol. During the first visit, the previous root canal filling is removed, the canal is cleaned and shaped, and the assigned medication is placed. Postoperative pain will be assessed using a Visual Analog Scale (VAS) at 6, 12, 24, 48, 72 hours, and 7 days. Flare-up incidence (sudden severe pain or swelling) will also be monitored. In the second visit, the medication is removed, and the canal is permanently sealed using a bioceramic sealer and gutta-percha. The results will help determine if these herbal alternatives can provide a more comfortable treatment experience for patients undergoing root canal retreatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
- Model description
- participants will be randomly assigned to one of three parallel groups. each group will receive a different intracanal medicament following non surgical root canal retreatment. post operative pain and flare up incidence will be assessed and compared between the three groups.
| Arm | Type | Receives |
|---|---|---|
| Calcium Hydroxide Group | Active comparator | Drug: Calcium hydroxidePatients receiving conventional Calcium Hydroxide paste as an intracanal medication. |
| Propolis Group | Experimental | Drug: Propolis ExtractPatients receiving a Propolis-based herbal extract as an intracanal medication |
| Green Tea Group | Experimental | Drug: Green Tea Polyphenolics (EGCG)Patients receiving Green Tea Polyphenolics (EGCG) as an intracanal medication. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Failed previously performed endodontic treatment of single-rooted teeth.
- Presence of a periapical lesion ranging from 1 mm to 2 mm in diameter.
- Teeth with complete root formation.
- Teeth without evidence of external or internal root resorption.
Key exclusion criteria (5 listed)
- Pregnant females.
- Patients with uncontrolled systemic diseases.
- Patients currently under antibiotic or analgesic administration.
- Patients presenting with facial swelling.
- Teeth not indicated for endodontic retreatment (e.g., poor oral hygiene, mobile teeth, or recessed 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 |
|---|---|---|
| Calcium hydroxideFollowing chemo-mechanical preparation and canal drying, Calcium Hydroxide paste is inserted into the root canal using a specialized syringe. The material is placed 0.5-1 mm from the apex to ensure complete filling without extrusion. It remains in the canal until the second visit for obturation. | Drug | Calcium Hydroxide Group |
| Propolis ExtractAfter cleaning, shaping, and drying the root canal, a Propolis-based natural resinous substance is used as an intracanal medication. The material is delivered via syringe to a depth of 0.5-1 mm from the apex. This herbal medicament is utilized for its antimicrobial and anti-inflammatory properties. | Drug | Propolis Group |
| Green Tea Polyphenolics (EGCG)Following the standardized cleaning protocol and canal drying, Green Tea Polyphenolics (EGCG) extract is inserted as an intracanal medication. The extract is placed 0.5-1 mm from the apex using a syringe. It serves as an herbal antioxidant and antimicrobial agent during the inter-appointment period. | Drug | Green Tea Group |
Primary outcome
Postoperative pain
Time frame: 6, 12, 24, 48, 72 hours and 7 days after the first visit to collect the postoperative pain data.
Postoperative pain is to be assessed using visual analog scale (VAS), A scale from (0 to 10) where "0" means no pain and "10" means a severe pain that has never faced before. Patients will be contacted by phone at 6, 12, 24, 48, 72 hours and 7 days after the first visit to collect the postoperative pain data.
Flare-Up Incidence
Time frame: Within 7 days post-treatment
Flare-up is assessed through asking the patient to notify the investigator if any sudden severe pain or swelling takes place. This could require an unscheduled emergency visit or prescription of additional medication.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2026.
- Individual participant dataSharing planned: No. Individual Participant Data (IPD) will not be shared due to privacy concerns and the limited scope of data use approved by the ethics committee. The study is designed for internal analysis only and does not include provisions for public data sharing
Related trials for Postoperative Pain
RecruitingPhase 4
ESP Blocks for Posterior Spinal Fusion
Postoperative Pain
Recruiting
Effect of Cryotherapeutic and Nanotherapeutic Sodium Hypochlorite on Post-Operative Endodontic Pain.
Symptomatic Irreversible Pulpitis, Symptomatic Apical Periodontitis
RecruitingPhase 2
REctus Sheath Trial
Acute Pain, Postoperative Pain, Acute
Not yet recruiting
Effect of Pectoral Nerve Block (PECS) Using Magnesium Sulfate Added to Dexamethasone on Quality of Recovery and Chronic Post-Mastectomy Pain
Breast Cancer, Postoperative Pain
Active, not recruitingPhase 4
Effect of Dexmedetomidine on Postoperative Pain in Spinal Anesthesia for Cesarean Section at Assuit University Hospital
Cesarean Section
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.
Questions about this trial
What is this clinical trial studying?
A study testing Calcium hydroxide, Propolis Extract and Green Tea Polyphenolics (EGCG) in people with Postoperative Pain and Flare Up, Symptom, run by Minia 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 5 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: opening soon, as of the sponsor's last update on 11 May 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Abdullah Aiman Ghanemah (+201060493986, abdullah.ghanema@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative pain (time frame: 6, 12, 24, 48, 72 hours and 7 days after the first visit to collect the postoperative pain data.). The study lists 2 primary outcomes in all. 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 11 May 2026.