Local Dexamethasone Administration in Symptomatic Irreversible Pulpitis (SIPDEX)
Comparison of the Effects of Submucosal and Intraligamentary Dexamethasone Administration on Anesthetic Success and Pain Control in Patients With Symptomatic Irreversible Pulpitis: A Randomized Clinical Trial
Symptomatic irreversible pulpitis is associated with a high incidence of inadequate pulpal anesthesia during endodontic treatment, particularly in mandibular molar teeth. Failure to achieve profound anesthesia may result in increased intraoperative pain and patient discomfort. Corticosteroids have been suggested as adjunctive agents to improve pain control and reduce inflammatory responses; however, the influence of different local administration techniques on anesthetic success and postoperative pain remains unclear.
The aim of this randomized controlled clinical trial is to compare the effects of submucosal and intraligamentary dexamethasone administration on anesthetic success and pain control in patients with symptomatic irreversible pulpitis. A total of 84 participants requiring root canal treatment of mandibular first or second molars diagnosed with symptomatic irreversible pulpitis will be randomly allocated to one of three groups: (1) inferior alveolar nerve block (IANB) followed by submucosal saline injection (control group), (2) IANB followed by submucosal dexamethasone injection, and (3) IANB followed by intraligamentary dexamethasone injection.
All participants will receive standardized endodontic treatment under local anesthesia. The primary outcome measure is anesthetic success during access cavity preparation and pulp extirpation. Secondary outcome measures include postoperative pain intensity at 6, 12, 24, 48, and 72 hours, and postoperative analgesic consumption. The results of this study may provide evidence regarding the effectiveness of different local dexamethasone administration techniques and contribute to improved pain management strategies in endodontic practice.
연구 개요
상태
상태
정황
정황
개입 / 치료
개입 / 치료
상세 설명
Symptomatic irreversible pulpitis is associated with a high incidence of failure of inferior alveolar nerve block anesthesia, particularly in mandibular molars, resulting in pain during endodontic treatment and the frequent need for supplemental anesthesia. Corticosteroids have been investigated as adjunctive agents because of their anti-inflammatory properties and their potential to improve anesthetic success and reduce postoperative pain. However, limited evidence is available regarding the influence of different local administration techniques on these outcomes.
This prospective, randomized, controlled, single-blind clinical trial aims to compare the effects of submucosal and intraligamentary administration of dexamethasone on anesthetic success and postoperative pain following inferior alveolar nerve block in patients with symptomatic irreversible pulpitis of mandibular first or second molars.
Eighty-four participants will be randomly allocated into three parallel groups (28 participants per group):
Group 1 (Control): Inferior alveolar nerve block followed by submucosal injection of normal saline (placebo).
Group 2: Inferior alveolar nerve block followed by submucosal injection of dexamethasone.
Group 3: Inferior alveolar nerve block followed by intraligamentary injection of dexamethasone.
The primary outcome is anesthetic success, assessed using the Heft-Parker Visual Analog Scale (HP-VAS) during access cavity preparation and pulp extirpation. Secondary outcomes include postoperative pain intensity assessed using the HP-VAS at 6, 12, 24, 48, and 72 hours after treatment, as well as the need for postoperative analgesic medication. The findings of this study may help identify the most effective local administration technique for dexamethasone to improve anesthetic success and postoperative pain management in patients with symptomatic irreversible pulpitis.
연구 유형
연구 유형
등록 (추정된)
등록
단계
단계
- 해당 없음
연락처 및 위치
연구 연락처
연구 연락처
- 이름: Elif İrem Altıntaş, Research Assistant
- 전화번호: +905425491411
- 이메일: eialtintas@icloud.com
연구 연락처 백업
- 이름: Ayşe Karadayı, Assistant Professor
- 전화번호: +905330527343
- 이메일: ayse.karadayi@marmara.edu.tr
연구 장소
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Istanbul, 터키 (Türkiye)
- 모병
- Marmara University Faculty of Dentistry
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참여기준
자격 기준
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
설명
Inclusion Criteria:
- Patients aged 18 to 65 years.
- ASA I or ASA II systemic health status.
- Symptomatic irreversible pulpitis in a mandibular molar tooth.
- Positive response to pulp sensibility tests.
- Preoperative pain score greater than 54 mm on the Heft-Parker Visual Analog Scale (HP-VAS).
- Ability to understand the study procedures and provide written informed consent.
Exclusion Criteria:
- Pregnancy or lactation.
- Allergy or contraindication to articaine, dexamethasone, or study-related medications.
- Use of analgesics, anti-inflammatory drugs, or antibiotics within the previous 12 hours.
- Presence of periapical radiolucency or diagnosis of pulpal necrosis.
- Significant systemic disease (ASA III or higher).
- Inability to complete pain assessment forms or follow study procedures.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 하나의
팔의 수
무기와 개입
참가자 그룹 / 팔참가자 그룹 / 팔 |
개입 / 치료개입 / 치료 |
|---|---|
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위약 비교기: Control Group
Participants receive an inferior alveolar nerve block followed by a submucosal saline injection prior to endodontic treatment.
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Normal saline is administered submucosally following inferior alveolar nerve block in patients with symptomatic irreversible pulpitis undergoing root canal treatment.
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실험적: Submucosal Dexamethasone
Participants receive an inferior alveolar nerve block followed by submucosal dexamethasone administration prior to endodontic treatment.
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Dexamethasone (8 mg/2 mL) is administered submucosally following inferior alveolar nerve block in patients with symptomatic irreversible pulpitis undergoing root canal treatment.
Dexamethasone (8 mg/2 mL) is administered intraligamentarily following inferior alveolar nerve block in patients with symptomatic irreversible pulpitis undergoing root canal treatment.
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실험적: Intraligamentary Dexamethasone
Participants receive an inferior alveolar nerve block followed by intraligamentary dexamethasone administration prior to endodontic treatment.
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Dexamethasone (8 mg/2 mL) is administered submucosally following inferior alveolar nerve block in patients with symptomatic irreversible pulpitis undergoing root canal treatment.
Dexamethasone (8 mg/2 mL) is administered intraligamentarily following inferior alveolar nerve block in patients with symptomatic irreversible pulpitis undergoing root canal treatment.
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연구는 무엇을 측정합니까?
주요 결과 측정
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Success of Inferior Alveolar Nerve Block Anesthesia
기간: Periprocedural (during access cavity preparation and pulp extirpation)
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Anesthetic success will be assessed using the Heft-Parker Visual Analog Scale (HP-VAS) during access cavity preparation and pulp extirpation.
Successful anesthesia is defined as no pain or mild pain (HP-VAS <54 mm) without the need for supplemental anesthesia.
Moderate or severe pain (HP-VAS ≥54 mm) or the need for supplemental anesthesia will be considered anesthetic failure.
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Periprocedural (during access cavity preparation and pulp extirpation)
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2차 결과 측정
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Postoperative Pain Intensity
기간: 6, 12, 24, 48, and 72 hours after treatment
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Postoperative pain intensity will be assessed using the Heft-Parker Visual Analog Scale (HP-VAS) at 6, 12, 24, 48, and 72 hours after treatment.
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6, 12, 24, 48, and 72 hours after treatment
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Need for Postoperative Analgesic Medication
기간: Up to 72 hours after treatment
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The need for postoperative analgesic medication will be assessed by recording whether participants require rescue analgesic medication during the 72-hour follow-up period after treatment.
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Up to 72 hours after treatment
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공동 작업자 및 조사자
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
연구 시작
기본 완료 (추정된)
기본 완료
연구 완료 (추정된)
연구 완료
연구 등록 날짜
최초 제출
최초 제출
QC 기준을 충족하는 최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
처음 게시됨
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
마지막 업데이트 게시됨
QC 기준을 충족하는 마지막 업데이트 제출
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
키워드
추가 관련 MeSH 약관
기타 연구 ID 번호
기타 연구 ID 번호
- SIPDEX2026
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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