- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT07703553
Comparing Pre-Anesthetic Approaches in Dentistry
Comparison of Pre-Anesthetic Approaches to Reduce Needle Insertion Pain Before Dental Local Anesthesia.
The main purpose of this study is to find out which pre-treatment method works best to reduce pain from dental anesthesia injections in adult patients. Researchers will compare four different approaches:
Topical numbing spray (10% lidocaine) Brief cold application (cryotherapy) A combination of both cold application and cooled numbing spray A control group Participants who need a standard local anesthesia injection for their dental treatment will be randomly assigned to one of these four groups. Right after the needle insertion, participants will rate their pain level using a simple visual scale, and their physical reactions will also be observed and scored by the researchers.
연구 개요
상세 설명
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
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Outside of the US
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Sanliurfa, Outside of the US, 터키 (Türkiye), 63300
- Harran University Faculty of Dentristry,Departman of Endodonti
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참여기준
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
설명
Inclusion Criteria:
- Adults aged between 18 and 65 years.
- Systemically healthy individuals classified as ASA I or II.
- Patients presenting to the Harran University Faculty of Dentistry Hospital who require local anesthesia during dental treatment.
- Treatment plan requiring mandibular block anesthesia, anterior/posterior infiltration, or palatal infiltration.
- No regular use of analgesics (NSAIDs, paracetamol, etc.) within the last 7 days.
- No history of allergy to cold application or topical anesthetics.
Exclusion Criteria:
- Regular use of analgesics (NSAIDs, paracetamol, etc.) within the last 7 days.
- Chronic pain syndrome, migraine, or systemic diseases requiring continuous use of analgesics.
- Pregnancy or lactation.
- Presence of active lesions in the oral mucosa, severe periodontal infection, or pathology at the injection site.
- History of allergy to topical gel or cold application.
- Psychiatric disorders or conditions preventing compliance with dental treatment.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 지지 요법
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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실험적: Topical Anesthetic Spray
Application of 10% lidocaine spray to the oral mucosa before local anesthesia.
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Topical application of 10% lidocaine spray to reduce injection pain.
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실험적: Cryotherapy
Application of an ice pen to the oral mucosa for 60 seconds before local anesthesia.
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Pre-cooling the injection site using an ice pen for 60 seconds.
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실험적: Combination Arm Type: Experimental
Application of an ice pen for 60 seconds followed by 10% lidocaine spray before local anesthesia.
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Topical application of 10% lidocaine spray to reduce injection pain.
Pre-cooling the injection site using an ice pen for 60 seconds.
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간섭 없음: Control
Standard local anesthesia injection without any pre-anesthetic intervention.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Pain intensity during initial needle insertion (VAS)
기간: During the initial local anesthesia needle insertion.
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Subjective pain levels will be assessed by participants using a Visual Analog Scale (VAS) ranging from 0 to 10 mm.
Higher scores indicate greater pain.
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During the initial local anesthesia needle insertion.
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Objective pain assessment using Sound-Eye-Motor (SEM) scale
기간: During the initial local anesthesia needle insertion.
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Pain levels will be assessed objectively by the researchers based on the participants' sound, eye, and motor reactions using the Sound, Eye, and Motor (SEM) scale.
Total scores range from 0 to 5, where higher scores indicate greater pain.
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During the initial local anesthesia needle insertion.
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공동 작업자 및 조사자
간행물 및 유용한 링크
일반 간행물
- 1. Chandrasekaran, J., et al., Efficacy of painless injection technique-Vibraject-Clinical trial in Chennai, India. 2014. 2. Kumar, M., R. Chawla, and M. Goyal, Topical anesthesia. Journal of Anaesthesiology Clinical Pharmacology, 2015. 31(4): p. 450-456. 3. Ghaderi, F., S. Banakar, and S. Rostami, Effect of pre-cooling injection site on pain perception in pediatric dentistry:"A randomized clinical trial". Dental research journal, 2013. 10(6): p. 790. 4. Aminabadi, N.A. and R.M.Z. Farahani, The effect of pre-cooling the injection site on pediatric pain perception during the administration of local anesthesia. The journal of contemporary dental practice, 2012. 10: p. 43-50. 5. Lakshmanan, L. and V. Ravindran, Efficacy of cryotherapy application on the pain perception during intraoral injection: a randomized controlled trial. International Journal of Clinical Pediatric Dentistry, 2021. 14(5): p. 616. 6. Wiswall, A.T., Palatal anesthesia: comparison of four techniques for decreasing injection discomfort. 2011.
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (실제)
연구 완료 (실제)
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
기타 연구 ID 번호
- HRÜ/26.02.87
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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