- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT07699315
Preoperative Dexamethasone Injection to Improve Local Anesthesia Success in Endodontic Treatment (DILAS)
Preoperative Intraligamentary Injection of Dexamethasone Can Improve the Anesthetic Success Rate of 2% Lidocaine During the Endodontic Management of Mandibular Molars With Symptomatic Irreversible Pulpitis
This study aims to determine whether giving a single dose of 4mg dexamethasone before root canal treatment can reduce the amount of pain patients experience during the procedure . Patients diagnosed with symptomatic Irreversible Pulpitis requiring endodontic treatment will be enrolled. Participants will receive either dexamethasone or placebo before treatment , and pain during the procedure will be measured using a Visual Analogue Scale (VAS) .
The findings may help improve pain management strategies during root canal treatment .
연구 개요
상세 설명
Symptomatic irreversible pulpitis is a common cause of severe dental pain, and achieving adequate pain control during endodontic treatment remains a challenge despite the use of local anesthesia. Inflammatory mediators present in inflamed pulp tissues may reduce the effectiveness of local anesthetics , resulting in persistent intraoperative pain.
Dexamethasone is a corticosteroid with potent anti-inflammatory properties that may reduce inflammatory mediator release and improve pain control . This randomized controlled clinical trial aims to evaluate the effectiveness of preoperative 4mg dose of dexamethasone compared with placebo in reducing intraoperative pain during endodontic treatment of teeth diagnosed with symptomatic irreversible pulpitis.
Eligible participants will be randomly allocated to receive either dexamethasone or placebo before treatment . Standard local anesthesia and endodontic procedures will be performed for all participants .
Intraoperative pain intensity will be assessed using a Visual Analogue Scale. The primary outcome will be the difference in intraoperative pain scores between the two groups.
The results of this study may provide evidence regarding the role of preoperative dexamethasone as an adjunct for improving pain control during endodontic treatment .
연구 유형
등록 (추정된)
단계
- 4단계
연락처 및 위치
연구 연락처
- 이름: Ayesha S Janjua, BDS
- 전화번호: +92 321 5252096
- 이메일: ashsarwar@gmail.com
참여기준
자격 기준
공부할 수 있는 나이
- 성인
건강한 자원 봉사자를 받아들입니다
설명
Inclusion Criteria:
- Patients with pain VAS >/= 6
- Carious exposed mandibular molar with symptomatic irreversible pulpitis
- Patients between ages 18-60 years
- American Society of Anesthesiologists class I or II medical histories -
Exclusion Criteria:
1. Patients with contraindications to local anesthesia solution or dexamethasone 2.Pregnant or breast-feeding females 4.Tooth having fused/extra roots, full coverage crowns, or poor periodontal status 5. Patients taking drugs which could affect the pain perception
-
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: Dexamethasone Group
Participants receive dexamethasone as an adjunct to local anesthesia before endodontic treatment for symptomatic irreversible pulpitis
|
participants receive 4mg dexamethasone administered via intraligamental infiltration followed by inferior alveolar nerve block before endodontic treatment of mandibular molars with symptomatic irreversible pulpitis
|
|
위약 비교기: Saline
participants receive normal saline as a placeb adjunct to local anesthesia before endodontic treatment for symptomatic irreversible pulpitis
|
participants receive an equivalent volume of normal saline administered via intraligamental infiltration before root canal treatment for symptomatic irreversible pulpitis
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Intraoperative pain intensity
기간: Pain intensity assessed intraoperatively from initiation of access cavity preparation until completion of canal instrumentation during a single visit ( approximately 30-90 minutes).
|
intraoperative pain intensity measured using the Heft-parker Visual Analogue Scale following root canal treatment
|
Pain intensity assessed intraoperatively from initiation of access cavity preparation until completion of canal instrumentation during a single visit ( approximately 30-90 minutes).
|
공동 작업자 및 조사자
수사관
- 수석 연구원: Dr.Ayesha S Janjua, BDS, Watim Medical and Dental College
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
- WMDC/R&D(ERB)/2024/157
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
미국에서 제조되어 미국에서 수출되는 제품
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