根管治療における耳栓の影響：咽頭反射と患者の快適性
根管治療を受ける患者における嘔吐反射の重症度、行動反応、およびストレスバイオマーカーとしての唾液α-アミラーゼレベルに対するカスタムメイドシリコンイヤープラグ使用の効果：無作為化比較試験
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.
調査の概要
詳細な説明
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.
研究の種類
入学 (実際)
段階
- 適用できない
連絡先と場所
研究場所
-
-
-
Kahramanmaraş、トルコ（Türkiye）、46140
- Kahramanmaraş Sütçü İmam Universty
-
-
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
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
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：ダブル
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：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. |
|
介入なし：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. |
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Behavioural Gag-Reflex Score
時間枠：Throughout the root canal procedure (continuous observation by a blinded assessor)
|
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)
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Behavioural Gag-Reflex Severity Distribution
時間枠：Throughout the root canal procedure
|
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
|
|
Gag-Related Interruption Ratio
時間枠：Throughout the procedure
|
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
|
|
Salivary α-Amylase Activity
時間枠：Immediately before and immediately after the procedure
|
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
|
|
Total Treatment Time
時間枠：Throughout the procedure
|
Time from start of access-cavity preparation to completion of root-canal filling, measured with a digital stopwatch. |
Throughout the procedure
|
協力者と研究者
スポンサー
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
キーワード
追加の関連 MeSH 用語
その他の研究ID番号
- HRÜ/25.09.54
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
IPD プランの説明
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 共有時間枠
Data will be available after publication of the study results and for 5 years thereafter.
IPD 共有アクセス基準
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 共有サポート情報タイプ
- STUDY_PROTOCOL
- SAP
- ICF
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
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