Het effect van oordopjes op de kokhalsreflex en patiëntcomfort tijdens wortelkanaalbehandeling
Het effect van het gebruik van op maat gemaakte siliconen oordopjes op de ernst van de kokhalsreflex, gedragsreacties en speeksel alfa-amylase niveaus als stressbiomarker bij patiënten die een wortelkanaalbehandeling ondergaan: een gerandomiseerde gecontroleerde studie
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.
Studie Overzicht
Toestand
Conditie
Interventie / Behandeling
Gedetailleerde beschrijving
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.
Studietype
Inschrijving (Werkelijk)
Fase
- Niet toepasbaar
Contacten en locaties
Studie Locaties
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Kahramanmaraş, Turkije (Türkiye), 46140
- Kahramanmaraş Sütçü İmam Universty
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
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
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Dubbele
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
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Experimenteel: 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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Geen tussenkomst: 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. |
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Behavioural Gag-Reflex Score
Tijdsspanne: 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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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Behavioural Gag-Reflex Severity Distribution
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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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Medewerkers en onderzoekers
Sponsor
Studie record data
Bestudeer belangrijke data
Studie start (Werkelijk)
Primaire voltooiing (Werkelijk)
Studie voltooiing (Werkelijk)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Werkelijk)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- HRÜ/25.09.54
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
Beschrijving IPD-plan
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-tijdsbestek voor delen
Data will be available after publication of the study results and for 5 years thereafter.
IPD-toegangscriteria voor delen
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 delen Ondersteunend informatietype
- LEERPROTOCOOL
- SAP
- ICF
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
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