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.
연구 개요
상태
연구 유형
등록 (추정된)
단계
- 해당 없음
연락처 및 위치
연구 연락처
- 이름: Abdullah Aiman Ghanemah
- 전화번호: +201060493986
- 이메일: abdullah.ghanema@gmail.com
참여기준
자격 기준
공부할 수 있는 나이
- 어린이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
설명
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).
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 더블
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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활성 비교기: 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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실험적: 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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실험적: 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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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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플레어 발생률
기간: 치료 후 7 일 이내에
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갑작스런 심한 통증이나 부기가 발생하면 환자에게 조사자에게 알리도록 요청함으로써 플레어 업이 평가됩니다. 이를 위해서는 예정되지 않은 응급 방문 또는 추가 약물 처방이 필요할 수 있습니다. |
치료 후 7 일 이내에
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Postoperative pain
기간: 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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공동 작업자 및 조사자
스폰서
연구 기록 날짜
연구 주요 날짜
연구 시작 (추정된)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- EC-MU Research No.1254
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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