Effect of a Herbal Intracanal Medication On Postoperative Pain And Flare up Incidence In Non Surgical Root Canal Retreatment
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.
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.
Studie Overzicht
Toestand
Interventie / Behandeling
Studietype
Inschrijving (Geschat)
Fase
- Niet toepasbaar
Contacten en locaties
Studiecontact
- Naam: Abdullah Aiman Ghanemah
- Telefoonnummer: +201060493986
- E-mail: abdullah.ghanema@gmail.com
Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
- Kind
- Volwassen
- Oudere volwassene
Accepteert gezonde vrijwilligers
Beschrijving
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).
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Dubbele
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
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Actieve vergelijker: Calcium Hydroxide Group
Patients receiving conventional Calcium Hydroxide paste as an intracanal medication.
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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.
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Experimenteel: Propolis Group
Patients receiving a Propolis-based herbal extract as an intracanal medication
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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.
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Experimenteel: Green Tea Group
Patients receiving Green Tea Polyphenolics (EGCG) as an intracanal medication.
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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.
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Opflakkingsincidentie
Tijdsspanne: Binnen 7 dagen na de behandeling
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Flare-up wordt beoordeeld door de patiënt te vragen de onderzoeker op de hoogte te stellen als er plotselinge ernstige pijn of zwelling plaatsvindt. Dit kan een ongepland noodbezoek of recept van extra medicatie vereisen. |
Binnen 7 dagen na de behandeling
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Postoperative pain
Tijdsspanne: 6, 12, 24, 48, 72 hours and 7 days after the first visit to collect the postoperative pain data.
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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. |
6, 12, 24, 48, 72 hours and 7 days after the first visit to collect the postoperative pain data.
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Medewerkers en onderzoekers
Sponsor
Studie record data
Bestudeer belangrijke data
Studie start (Geschat)
Primaire voltooiing (Geschat)
Studie voltooiing (Geschat)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Werkelijk)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
- Pijn
- Neurologische manifestaties
- Postoperatieve complicaties
- Pathologische processen
- Ziekte attributen
- Herhaling
- Pathologische aandoeningen, tekenen en symptomen
- Tekenen en symptomen
- Symptoom Opflakkering
- Pijn, postoperatief
- Anorganische chemicaliën
- Polymeren
- Macromoleculaire stoffen
- Anionen
- Ionen
- Elektrolyten
- Hydroxiden
- Alkalies
- Biologische producten
- Complexe mengsels
- Biopolymeren
- Plant exsudeert
- Calciumverbindingen
- Harsen, plant
- Propolis
- epigallocatechin gallate
- Calciumhydroxide
Andere studie-ID-nummers
- EC-MU Research No.1254
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
Beschrijving IPD-plan
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
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