임상 레이더 AI | ||
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임상시험 NCT07493200은(는) Gag Reflex에 대해 진행중, 모집종료 상태입니다. 모든 세부 정보를 보려면 임상시험 레이더 카드 뷰와 AI 발견 도구를 확인하거나 여기에서 무엇이든 물어보세요. | ||
하나의 임상시험이 필터 기준과 일치합니다.
카드 뷰
The Effect of Earplugs on Gag Reflex and Patient Comfort in Root Canal Treatment 40
임상시험 세부 정보는 주로 영어로 제공됩니다. 하지만 임상 레이더 AI가 도와드릴 수 있습니다! '임상시험 설명'를 클릭하여 선택한 언어로 임상시험 정보를 확인하고, 이에 대해 AI와 논의해 보세요.
임상시험 NCT07493200은(는) Gag Reflex에 대해 알아보는 중재연구입니다. 현재 상태는 진행중, 모집종료이며, 연구는 2025년 5월 12일에 시작되어 40명의 참여자를 모집하고 있습니다. Beyhan Başkan이(가) 진행하며, 2026년 4월 30일까지 완료될 예정입니다. ClinicalTrials.gov의 가장 최근 정보는 2026년 3월 25일에 갱신되었습니다.
간단한 개요
Background:
Root canal treatment is a common dental procedure used to save infected teeth. However, some patients experience a strong gag reflex during the treatment. This reflex can make it very difficult for the dentist to work, cause significant stress for the patient, and prolong the procedure. Current methods to control the gag reflex, such as anesthesia or sedation, can be complicated, require special equipmen...
더 보기공식 제목
The Effect of Using Custom-Made Silicone Earplips on Gag Reflex Severity, Behavioral Responses, and Salivary Alpha-Amylase Levels as a Stress Biomarker in Patients Undergoing Root Canal Treatment: A Randomized Controlled Trial
질환명
Gag Reflex출판물
이 임상시험에 대해 발표된 과학 논문 및 연구 자료.기타 연구 식별자
- HRÜ724.09.54
NCT 번호
실제 연구 시작일
2025-05-12
최신 업데이트 게시
2026-03-25
예상 연구 완료일
2026-04-30
계획된 등록 인원
40
연구종류
중재연구
단계/상
해당 없음
상태
진행중, 모집종료
키워드
Salivary Alpha-Amylase
Root Canal Treatment
Randomized Controlled Trial
Root Canal Treatment
Randomized Controlled Trial
주요 목적
기타
설계 할당
무작위배정
중재 모델
평행설계
맹검 (마스킹)
단일맹검
시험군 / 개입
| 참가자 그룹/시험군 | 개입/치료 |
|---|---|
실험적Experimental Group Patients in this group (n=20) will have a custom-made silicone earplug placed in the ear opposite the side where the dentist is working during their root canal treatment. The earplug is fabricated immediately before the procedure using soft silicone material to ensure a comfortable, personalized fit. No other pharmacological or behavioral interventions for gag reflex control will be used. | Custom-Made Silicone Earplug A personalized earplug fabricated from a soft, two-component addition-cure silicone (C-type silicone), commonly used for dental impressions. The two components are mixed according to the manufacturer's instructions and gently injected into the patient's external auditory canal on the side contralateral to the tooth receiving treatment. The silicone is allowed to polymerize for approximately 2-3 minutes, creating a cu...더 보기 |
비개입Control Group Patients in this group (n=20) will receive standard root canal treatment without any earplug placement. No interventions for gag reflex control will be used. All outcome measures (gag reflex severity, behavioral responses, treatment pause ratio, salivary alpha-amylase) will be collected in the same manner as for the experimental group. | 해당 없음 |
주요결과변수
이차결과변수
| 결과변수 | 측정값 설명 | 시간 범위 |
|---|---|---|
Gag Reflex Severity | The severity of the gag reflex will be assessed using the Dickinson and Fiske Gagging Severity Index, a 5-point ordinal scale: 1=Normal (very mild, occasional, controllable by patient), 2=Mild (control achieved with support from dental team), 3=Moderate (consistent, limits treatment options), 4=Severe (occurs with any type of treatment, including simple visual examination), 5=Very Severe (affects patient behavior and dental visits, makes treatment impossible). The score will be recorded by the operator at the most challenging point of the root canal procedure (e.g., during rubber dam placement or access cavity preparation). | At the time of the root canal procedure (single time point during the most challenging part of treatment) |
| 결과변수 | 측정값 설명 | 시간 범위 |
|---|---|---|
Behavioral Response Score | Patient discomfort will be assessed by a trained observer (blinded to group allocation) who will record the presence or absence of 8 specific behavioral signs of distress during the procedure: (1) eye squeezing, (2) sweating (forehead or upper lip), (3) muscle tension (hand clenching, leg movements), (4) withdrawal/attempts to avoid treatment, (5) groaning, (6) crying, (7) breath-holding, (8) increased saliva production. The total score (0-8) is calculated by summing the number of observed signs. This total score is further categorized as mild (0-2), moderate (3-4), severe (5-6), or very severe (7-8) for analysis. | Throughout the root canal procedure (continuous observation) |
참여 도우미
적격성 기준
연령대
성인, 노인
최소 연령
18 Years
참여 가능한 성별
전체
- Adult patients aged 18 years and older.
- Patients requiring non-surgical root canal treatment on a permanent tooth.
- Patients classified with a severe (score 4) or very severe (score 5) gag reflex according to the Dickinson and Fiske Gagging Severity Index.
- Patients who provide written informed consent to participate in the study.
- Patients with a mild or moderate gag reflex (Dickinson and Fiske scores 1, 2, or 3).
- Patients with any known ear pathology, anatomical anomaly of the ear canal, or active ear infection that would preclude the use of an earplug.
- Patients with a history of vertigo or balance disorders.
- Patients with medical conditions that could affect salivary flow or composition (e.g., Sjögren's syndrome, uncontrolled diabetes).
- Patients taking medications that could influence salivary alpha-amylase levels (e.g., systemic corticosteroids, psychotropic drugs).
- Pregnant or breastfeeding women.
- Patients unable to provide informed consent or comply with the study protocol.
Beyhan Başkan연구 책임자
Beyhan Başkan, 의뢰자-연구자, Assistant Professor, Kahramanmaras Sutcu Imam University
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Kahramanmaraş Sütçü İmam Universty, Kahramanmaraş, 46140, Turkey (Türkiye)