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Conventional Versus Computer-Assisted Dental Anesthesia

2026년 7월 24일 업데이트: Jose Leonardo Jimenez-Ortiz, University of Montemorelos

Conventional Versus Computer-Assisted Dental Anesthesia: A Pilot Study of a Randomized Clinical Trial

The purpose of this clinical trial was to compare two methods of delivering local dental anesthesia in undergraduate dental students: a computer-controlled local anesthetic delivery (CCLAD) system and a conventional dental syringe. The study evaluated whether the computer-controlled system reduced pain during the administration of local anesthesia compared with the conventional technique.

The main questions this study aimed to answer were:

Does a computer-controlled local anesthetic delivery system reduce pain during maxillary buccal infiltration compared with a conventional dental syringe? Are there differences in physiological responses (blood pressure, heart rate, and oxygen saturation) between the two anesthetic delivery methods? Which anesthetic delivery method do participants prefer after experiencing both techniques? Would participants recommend their preferred anesthetic delivery method to others? Participants attended two study visits approximately one week apart. Each participant received local anesthesia using both delivery methods in a randomized order, serving as his or her own control. Pain, dental anxiety, physiological parameters, anesthetic delivery preferences, and willingness to recommend the preferred method were assessed during the study.

연구 개요

상태

완전한

정황

마취, 국소

개입 / 치료

연구 유형

중재적

등록 (실제)

단계

해당 없음

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 장소

멕시코
- Nuevo León
  - Montemorelos, Nuevo León, 멕시코, 67530
    - University Dental Clinic, Montemorelos University School of Dentistry

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

성인
고령자

건강한 자원 봉사자를 받아들입니다

예

설명

Inclusion Criteria:

Undergraduate dental student enrolled in the Local Anesthesia course at the Montemorelos University School of Dentistry.
Aged 18 years or older.
Able and willing to provide written informed consent.
Willing to attend both study periods.

Exclusion Criteria:

Pregnancy or lactation.
Known allergy or contraindication to lidocaine or epinephrine.
Systemic conditions contraindicating elective dental treatment.
Use of medications that could alter cardiovascular responses.
Medical condition that could interfere with pain perception or study participation.

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

주 목적: 기초 과학
할당: 무작위
중재 모델: 크로스오버 할당
마스킹: 하나의

무기와 개입

참가자 그룹 / 팔 참가자 그룹 / 팔 시험 프로토콜에 따라 특정 중재/치료를 받거나 중재를 받지 않는 임상 시험 참가자 그룹 또는 하위 그룹입니다.	개입 / 치료 개입 / 치료 임상 연구의 초점이 되는 프로세스 또는 작업입니다. 개입에는 약물, 의료 기기, 절차, 백신 및 조사 중이거나 이미 사용 가능한 기타 제품이 포함됩니다. 개입에는 교육이나 식이요법 및 운동 수정과 같은 비침습적 접근법도 포함될 수 있습니다.
실험적: Computer-Controlled Local Anesthetic Delivery Participants received maxillary buccal infiltration anesthesia using a computer-controlled local anesthetic delivery (CCLAD) system during one of two study periods according to the randomized treatment sequence. Each participant received both study interventions and served as his or her own control.	장치: Computer-Controlled Local Anesthetic Delivery System Local anesthetic was administered using a computer-controlled local anesthetic delivery (CCLAD) system with 2% lidocaine containing 1:100,000 epinephrine through a 27-gauge short dental needle for maxillary buccal infiltration anesthesia. The device controlled the flow rate throughout anesthetic administration according to the manufacturer's operating protocol. 다른 이름들: SOGA-MINI
활성 비교기: Conventional Dental Syringe Participants received maxillary buccal infiltration anesthesia using a conventional aspirating dental syringe during one of two study periods according to the randomized treatment sequence. Each participant received both study interventions and served as his or her own control.	장치: Conventional Aspirating Dental Syringe Local anesthetic was administered using a conventional aspirating dental syringe with 2% lidocaine containing 1:100,000 epinephrine through a 27-gauge short dental needle for maxillary buccal infiltration anesthesia. Anesthetic administration followed the conventional manual injection technique.

참가자 그룹 / 팔

개입 / 치료

실험적: Computer-Controlled Local Anesthetic Delivery

Participants received maxillary buccal infiltration anesthesia using a computer-controlled local anesthetic delivery (CCLAD) system during one of two study periods according to the randomized treatment sequence. Each participant received both study interventions and served as his or her own control.

장치: Computer-Controlled Local Anesthetic Delivery System

Local anesthetic was administered using a computer-controlled local anesthetic delivery (CCLAD) system with 2% lidocaine containing 1:100,000 epinephrine through a 27-gauge short dental needle for maxillary buccal infiltration anesthesia. The device controlled the flow rate throughout anesthetic administration according to the manufacturer's operating protocol.

다른 이름들:

SOGA-MINI

활성 비교기: Conventional Dental Syringe

Participants received maxillary buccal infiltration anesthesia using a conventional aspirating dental syringe during one of two study periods according to the randomized treatment sequence. Each participant received both study interventions and served as his or her own control.

장치: Conventional Aspirating Dental Syringe

Local anesthetic was administered using a conventional aspirating dental syringe with 2% lidocaine containing 1:100,000 epinephrine through a 27-gauge short dental needle for maxillary buccal infiltration anesthesia. Anesthetic administration followed the conventional manual injection technique.

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정	측정값 설명	기간
Pain perception during local anesthetic administration 기간: Immediately after each anesthetic administration	Pain perceived during maxillary buccal infiltration anesthesia administered with a computer-controlled local anesthetic delivery system or a conventional aspirating dental syringe. Pain was assessed immediately after each intervention using a 10-cm Visual Analog Scale (VAS), where 0 indicated "no pain" and 10 indicated "worst imaginable pain".	Immediately after each anesthetic administration

2차 결과 측정

결과 측정	측정값 설명	기간
Dental anxiety 기간: Baseline (before the first study intervention)	Dental anxiety was assessed using the Modified Dental Anxiety Scale (MDAS; score range: 5-25). Higher scores indicate greater dental anxiety. Assessment was performed before the first study intervention.	Baseline (before the first study intervention)
Systolic and diastolic blood pressure 기간: Before, during, and immediately after each anesthetic administration	Blood pressure was measured using an automated monitor before, during, and immediately after anesthetic administration.	Before, during, and immediately after each anesthetic administration
Heart rate 기간: Before, during, and immediately after anesthetic administration	Heart rate was measured using a pulse oximeter before, during, and immediately after anesthetic administration.	Before, during, and immediately after anesthetic administration
Peripheral oxygen saturation (SpO₂) 기간: Before, during, and immediately after anesthetic administration	Peripheral oxygen saturation was measured using a pulse oximeter before, during, and immediately after anesthetic administration.	Before, during, and immediately after anesthetic administration
Participant-reported preferred anesthetic delivery method 기간: Immediately after completion of the second study intervention	Participants selected their preferred anesthetic delivery method (computer-controlled local anesthetic delivery system or conventional aspirating dental syringe) after experiencing both interventions.	Immediately after completion of the second study intervention
Willingness to recommend the preferred anesthetic delivery method 기간: Immediately after completion of the second study intervention	Willingness to recommend the preferred anesthetic delivery method was assessed using an 11-point Numeric Rating Scale (NRS; 0-10), where 0 indicated "not at all willing to recommend" and 10 indicated "extremely willing to recommend." Higher scores indicate greater willingness to recommend. Assessment was performed after completion of the second study intervention.	Immediately after completion of the second study intervention

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

University of Montemorelos

수사관

수석 연구원: Jose L Jimenez-Ortiz, DDS, Montemorelos University School of Dentistry

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (실제)

2025년 9월 2일

기본 완료 (실제)

2025년 12월 2일

연구 완료 (실제)

2025년 12월 2일

연구 등록 날짜

최초 제출

2026년 7월 20일

QC 기준을 충족하는 최초 제출

2026년 7월 24일

처음 게시됨 (실제)

2026년 7월 28일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 7월 28일

QC 기준을 충족하는 마지막 업데이트 제출

2026년 7월 24일

마지막으로 확인됨

2026년 7월 1일

추가 정보

이 연구와 관련된 용어

키워드

기타 연구 ID 번호

UM-ESEST-2025-015

개별 참가자 데이터(IPD) 계획

개별 참가자 데이터(IPD)를 공유할 계획입니까?

미정

IPD 계획 설명

A final decision regarding the sharing of de-identified individual participant data has not yet been made. Data sharing will be considered in accordance with institutional policies, participant confidentiality requirements, and applicable ethical and regulatory standards.

약물 및 장치 정보, 연구 문서

미국 FDA 규제 의약품 연구

아니

미국 FDA 규제 기기 제품 연구

아니

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. .

Conventional Versus Computer-Assisted Dental Anesthesia