- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT07618182
Effect of Two Different Concentrations of Sodium Hypochlorite on Post-Operative Pain Following Single-Visit Root Canal Treatment (NaOCl-RCT)
Effect of Two Different Concentrations of Sodium Hypochlorite on Post-Operative Pain Following Single-Visit Root Canal Treatment: A Randomized Controlled Trial
연구 개요
상세 설명
This study will be conducted in the Department of Operative Dentistry, Saidu College of Dentistry, Swat. Sodium hypochlorite is widely regarded as the gold standard irrigant in endodontics because of its tissue dissolution and antimicrobial properties. However, its concentration-dependent cytotoxicity may influence post-operative pain after treatment.
A randomized controlled trial design will be used with two parallel groups receiving either 2.5% or 5.25% sodium hypochlorite during standardized single-visit root canal treatment. A total of 116 participants aged 18-60 years requiring primary root canal therapy will be recruited using consecutive sampling.
All procedures including anesthesia, access preparation, working length determination, instrumentation, irrigation protocol, and obturation will be standardized. Post-operative pain will be recorded using a 100-mm Visual Analog Scale at 6, 12, 24, and 48 hours post-treatment.
Data analysis will be performed using IBM SPSS Statistics. Repeated measures analysis will compare pain scores between groups across different time intervals. Statistical significance will be considered at p < 0.05.
연구 유형
등록 (추정된)
단계
- 해당 없음
연락처 및 위치
연구 연락처
- 이름: Asad Ullah post graduate trainee
- 전화번호: +923451505838
- 이메일: drasadkhan14@gmail.com
참여기준
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
설명
Inclusion Criteria:
- Adult patients aged 18-60 years Systemically healthy individuals Permanent teeth with closed apices requiring primary root canal treatment Teeth diagnosed with symptomatic/asymptomatic irreversible pulpitis or pulpal necrosis Patients able to understand the Visual Analog Scale Patients willing to provide informed consent and complete follow-up
Exclusion Criteria:
- Uncontrolled systemic diseases Pregnant or breastfeeding women Allergy to sodium hypochlorite or local anesthetics Previously endodontically treated teeth Teeth with root resorption, vertical root fracture, or open apex Severe periodontal disease or mobility Use of analgesics, antibiotics, or anti-inflammatory drugs within previous 7 days
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 하나의
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
실험적: 2.5% Sodium Hypochlorite Group
Participants undergoing single-visit root canal treatment using 2.5% sodium hypochlorite as the irrigation solution.
|
Participants undergoing single-visit root canal treatment will receive root canal irrigation using either 2.5% sodium hypochlorite or 5.25% sodium hypochlorite solution.
Irrigation will be standardized by delivering 5 mL of the assigned solution per canal using a 30-gauge side-vented needle placed 2 mm short of the working length during chemo-mechanical preparation.
The concentration of sodium hypochlorite will be the only variable between study groups.
|
|
활성 비교기: 5.25% Sodium Hypochlorite Group
Participants undergoing single-visit root canal treatment using 5.25% sodium hypochlorite as the irrigation solution.
|
Participants undergoing single-visit root canal treatment will receive root canal irrigation using either 2.5% sodium hypochlorite or 5.25% sodium hypochlorite solution.
Irrigation will be standardized by delivering 5 mL of the assigned solution per canal using a 30-gauge side-vented needle placed 2 mm short of the working length during chemo-mechanical preparation.
The concentration of sodium hypochlorite will be the only variable between study groups.
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Post-Operative Pain Following Single-Visit Root Canal Treatment
기간: At 6 hours, 12 hours, 24 hours, and 48 hours after completion of treatment.
|
Assessment and comparison of post-operative pain intensity between the 2.5% sodium hypochlorite group and the 5.25% sodium hypochlorite group using a 100-mm Visual Analog Scale (VAS).
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At 6 hours, 12 hours, 24 hours, and 48 hours after completion of treatment.
|
|
Post-Operative Pain Score
기간: 6 hours, 12 hours, 24 hours, and 48 hours after treatment
|
Assessment of post-operative pain using a 100-mm Visual Analog Scale following single-visit root canal treatment.
|
6 hours, 12 hours, 24 hours, and 48 hours after treatment
|
공동 작업자 및 조사자
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 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .
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