근관 치료 시 귀마개가 구역 반사와 환자 편안함에 미치는 영향
근관치료를 받는 환자에서 맞춤형 실리콘 귀마개 사용이 구역반사 심각도, 행동 반응 및 스트레스 바이오마커로서의 타액 알파-아밀라아제 수준에 미치는 영향: 무작위 대조 시험
This study evaluated whether wearing an earplug during root canal treatment reduces the gag reflex and the stress it causes. Forty adults who had a severe or very severe gag reflex were randomly divided into two groups. One group received an earplug in the ear opposite to the side being treated; the other group received standard treatment without an earplug. The severity of the gag reflex was scored by an observer, stress was measured using a saliva sample (salivary alpha-amylase), and treatment time and gag-related interruptions were recorded. The results showed that the earplug group had lower gag-reflex scores, lower stress levels, and shorter treatment times with fewer interruptions. No side effects were reported. These findings suggest that a simple, low-cost earplug may help patients who gag easily during dental treatment.
연구 개요
상세 설명
Background: An exaggerated gag reflex is a common problem during dental treatment, especially in endodontics, where uninterrupted working time and moisture control are essential. Pharmacological approaches carry risks, and evidence for non-pharmacological methods is limited. Earplug stimulation of the external auditory canal has been proposed as a simple, non-invasive way to suppress the gag reflex.
Objective: To evaluate the effect of earplug application during endodontic treatment on gag-reflex severity, physiological stress (salivary alpha-amylase, sAA), and clinical efficiency (treatment time and gag-related interruption ratio).
Methods: This prospective, randomized controlled trial enrolled 40 adults with severe or very severe gagging (Dickinson-Fiske Gagging Severity Index grade 4-5) requiring endodontic treatment. Participants were randomly allocated 1:1 to an earplug group or a control group. A custom-moulded silicone earplug was placed in the ear contralateral to the operating field. The operator and the outcome assessor were blinded by an identical adhesive ear cover applied to all participants; participants could not be blinded. Gag-reflex severity was scored with an 8-item behavioural scale (0-8). Unstimulated whole saliva was collected before and after treatment for sAA measurement. Total treatment time and gag-related interruption time were recorded, and the interruption ratio was calculated as (interruption time / total treatment time) × 100. Non-parametric tests and baseline-adjusted ANCOVA on log-transformed sAA were used.
Results: The earplug group had a lower behavioural gag-reflex score (median 3.0 vs 5.5; p < 0.01) and a more favourable severity distribution (trend p < 0.01). sAA decreased after treatment with the earplug but increased in controls (median change -31.8% vs +76.2%); baseline-adjusted post-treatment sAA was 59% lower with earplug use (geometric mean ratio 0.41, 95% CI 0.32-0.53; p < 0.001). Treatment time and the interruption ratio were markedly lower with earplug use (both p < 0.001). No adverse effects were observed.
Conclusions: Earplug application during endodontic treatment was associated with reduced gag-reflex severity, an attenuated physiological stress response, and improved procedural efficiency. As a simple, inexpensive, non-invasive technique, the earplug may be a useful adjunct for managing severe gagging in endodontic practice. Larger, multi-centre trials with patient-reported outcomes are warranted.
Trial registration: ClinicalTrials.gov, NCT07493200.
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
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Kahramanmaraş, 터키 (Türkiye), 46140
- Kahramanmaraş Sütçü İmam Universty
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
Age over 18 years Need for endodontic treatment Score of 4 (severe gagging: occurs with all forms of treatment) or 5 (very severe gagging: makes treatment impossible) on the Dickinson and Fiske Gagging Severity Index (GSI)
Exclusion Criteria:
Systemic disease Pregnancy or lactation Diagnosed central or peripheral nervous system disorders Use of anti-emetic medication Ear infection or structural abnormality of the external auditory canal
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 더블
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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실험적: Experimental 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. |
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 custom-fit plug that conforms precisely to the individual contours of the ear canal. This ensures comfortable, continuous, and gentle tactile stimulation to the walls of the ear canal throughout the entire root canal procedure. The earplug is removed at the end of the treatment and is for single-patient use only. No other devices or pharmacological agents are used in conjunction with this intervention. |
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간섭 없음: Control 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. |
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Behavioural Gag-Reflex Score
기간: Throughout the root canal procedure (continuous observation by a blinded assessor)
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An 8-item behavioural observation scale (0-8) was used to quantify the intraoperative gag response. One point was assigned for each of: eye-squeezing, sweating, physical contraction, withdrawal, groaning, crying, breath-holding, and increased salivation. The total score was categorised as Mild (0-2), Moderate (3-4), Severe (5-6), or Very Severe (7-8). |
Throughout the root canal procedure (continuous observation by a blinded assessor)
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Behavioural Gag-Reflex Severity Distribution
기간: Throughout the root canal procedure
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The total 8-item behavioural score (0-8) was categorised as Mild (0-2), Moderate (3-4), Severe (5-6), or Very Severe (7-8). The distribution of these categories after treatment was compared between groups using the Cochran-Armitage trend test. |
Throughout the root canal procedure
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Gag-Related Interruption Ratio
기간: Throughout the procedure
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The cumulative duration of gag-related pauses was divided by total treatment time and multiplied by 100. Total treatment time was measured from the start of access-cavity preparation to completion of the root-canal filling. |
Throughout the procedure
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Salivary α-Amylase Activity
기간: Immediately before and immediately after the procedure
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Unstimulated whole saliva was collected before and after treatment, centrifuged (10,000 × g, 10 min, 4 °C), and stored at -80 °C. sAA activity was measured colorimetrically using a commercial kit (Elabscience, Cat. No. E-BC-K007-M) based on the DNS method; optical density was read at 540 nm. |
Immediately before and immediately after the procedure
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Total Treatment Time
기간: Throughout the procedure
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Time from start of access-cavity preparation to completion of root-canal filling, measured with a digital stopwatch. |
Throughout the procedure
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공동 작업자 및 조사자
스폰서
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
키워드
추가 관련 MeSH 약관
기타 연구 ID 번호
- HRÜ/25.09.54
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
De-identified individual participant data (demographic, behavioural, salivary α-amylase, and procedural time data) will be shared. Requests should be directed to the corresponding author.
IPD 공유 기간
Data will be available after publication of the study results and for 5 years thereafter.
IPD 공유 액세스 기준
De-identified IPD and supporting documents will be made available to researchers whose proposed use of the data has been approved by the corresponding author and the institutional ethics committee. Data will be shared for non-commercial research purposes only. Requests should be sent to beyhanbaskan@ksu.edu.tr.
IPD 공유 지원 정보 유형
- 연구_프로토콜
- 수액
- ICF
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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