Pain During Infiltration Injection in Anterior Maxillary Region by Transcodent Painless Needle Tips Versus Regular Needle Tips
Comparison of Pain During Infiltration Injection in Anterior Maxillary Region by Transcodent Painless Needle Tips Versus Regular Needle Tips: a Split-mouth Controlled Randomized Clinical Trial
연구 개요
상태
상세 설명
This randomized split-mouth controlled clinical trial aims to compare pain experienced during anterior maxillary infiltration anesthesia using Transcodent painless needle tips versus conventional dental needle tips. Dental injection pain is a common source of anxiety and may negatively affect patient acceptance of dental treatment. Recent advances in needle design, including the three-edge lancet grinding bevel and silicone-coated cannula of the Transcodent needle, have been developed to reduce tissue resistance during penetration and improve patient comfort.
A total of 60 adult patients requiring bilateral maxillary anterior infiltration anesthesia for dental treatment will be recruited from the Department of Operative Dentistry, Saidu College of Dentistry, Swat. Eligible participants will receive two supraperiosteal injections, one with a Transcodent painless needle tip and one with a conventional needle tip, on opposite sides of the maxillary arch. The order of needle use and injection site will be randomized using a balanced block randomization method. Prior to injection, 20% benzocaine topical anesthetic gel will be applied for two minutes. Each injection will consist of 0.9 mL of 2% lidocaine with 1:100,000 epinephrine administered over 30 seconds by the same operator.
Pain perception will be assessed immediately after each injection using a 100-mm Visual Analog Scale (VAS), where 0 indicates no pain and 100 indicates the worst imaginable pain. The primary outcome is the difference in mean VAS pain scores between Transcodent and conventional needle tips. Data will be analyzed using paired statistical methods appropriate for the distribution of the data.
The findings of this study will provide local evidence regarding the effectiveness of Transcodent painless needle tips in reducing injection-related pain during maxillary infiltration anesthesia and may contribute to improving patient comfort and reducing dental anxiety during routine dental procedures.
연구 유형
등록 (추정된)
단계
- 해당 없음
연락처 및 위치
연구 연락처
- 이름: Azra Umar, BDS
- 전화번호: +92 331 8080135
- 이메일: drumarhussain@gmail.com
연구 장소
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Mingora Swat, 파키스탄, 19200
- Saidu Collage of Dentistry, Saidu Sharif , Swat
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참여기준
자격 기준
공부할 수 있는 나이
- 성인
건강한 자원 봉사자를 받아들입니다
설명
Inclusion Criteria:
Adults aged 18 to 60 years. Patients requiring bilateral maxillary anterior infiltration anesthesia for dental treatment.
Patients undergoing endodontic procedures involving maxillary canines or premolars.
Presence of healthy maxillary teeth on both sides suitable for infiltration anesthesia.
Individuals with no systemic disease or neurological disorder affecting pain perception.
Ability to understand the study procedures and provide written informed consent.
Both male and female participants.
Exclusion Criteria:
Pregnant or lactating women. Use of analgesics, sedatives, or other pain-modifying medications within the previous 12 hours.
Known allergy or hypersensitivity to local anesthetics, benzocaine, lidocaine, or epinephrine.
Presence of active infection, inflammation, swelling, or pathology at the injection site.
Severe dental anxiety, needle phobia, or inability to cooperate with study procedures.
Individuals unable or unwilling to provide informed consent.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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실험적: Sequence A: Transcodent Needle First
Participants receive anterior maxillary infiltration anesthesia using a Transcodent painless needle tip with a three-edge lancet grinding bevel and silicone-coated cannula.
Pain is assessed immediately after injection using a 100-mm Visual Analog Scale (VAS).
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A dental injection needle with a three-edge lancet grinding bevel and silicone-coated cannula designed to reduce tissue resistance and injection pain during anterior maxillary infiltration anesthesia.
A standard dental injection needle with a conventional bevel design used for anterior maxillary infiltration anesthesia.
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실험적: Sequence B: Conventional Needle First
Participants receive anterior maxillary infiltration anesthesia using a conventional dental needle tip.
Pain is assessed immediately after injection using a 100-mm Visual Analog Scale (VAS).
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A dental injection needle with a three-edge lancet grinding bevel and silicone-coated cannula designed to reduce tissue resistance and injection pain during anterior maxillary infiltration anesthesia.
A standard dental injection needle with a conventional bevel design used for anterior maxillary infiltration anesthesia.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Pain Score During Anterior Maxillary Infiltration Injection
기간: Immediately after each injection
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Pain perception measured using a 100-mm Visual Analog Scale (VAS), where 0 indicates no pain and 100 indicates the worst imaginable pain.
Pain scores will be recorded immediately after administration of infiltration anesthesia using either a Transcodent
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Immediately after each injection
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공동 작업자 및 조사자
수사관
- 수석 연구원: Azra Umar, Saidu College of Dentistry, Swat, Paksitan
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
기타 연구 ID 번호
- SCD-OPER-2026-06
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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