Effect of a Herbal Intracanal Medication On Postoperative Pain And Flare up Incidence In Non Surgical Root Canal Retreatment
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Calcium hydroxide, Propolis Extract, Green Tea Polyphenolics (EGCG).
- Who it may be relevant to
- Registry conditions: Postoperative Pain, Flare Up, Symptom, Flare up. Basic parameters: No limits · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Effect Of Phytotherapeutics As Intracanal Medication On Postoperative Pain And Flare up Incidence In Non Surgical Root Canal Retreatment. (Randomized Clinical Trial)
Overview
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.
Interventions
- Drug Calcium hydroxide
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. - Drug Propolis Extract
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. - Drug 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.
Primary outcome measures
- Postoperative pain [Time frame: 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]
Eligibility criteria
Inclusion criteria
- 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.
Exclusion criteria
- 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).
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07578311 · EC-MU Research No.1254