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Lo studio clinico NCT07493200 per Gag Reflex è attivo, non in arruolamento. Consulti la vista a schede del Radar degli Studi Clinici e gli strumenti di scoperta IA per tutti i dettagli. Oppure, ponga pure una domanda qui. | ||
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The Effect of Earplugs on Gag Reflex and Patient Comfort in Root Canal Treatment 40
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La sperimentazione clinica NCT07493200 è uno studio interventistico per Gag Reflex, attualmente attivo, non in arruolamento. Avviato il 12 maggio 2025, prevede di arruolare 40 partecipanti. Sotto la guida di Beyhan Başkan, dovrebbe concludersi entro il 30 aprile 2026. I dati più recenti da ClinicalTrials.gov sono stati aggiornati l'ultima volta il 25 marzo 2026.
Sommario breve
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...
Mostra di piùTitolo ufficiale
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
Patologie
Gag ReflexPubblicazioni
Articoli scientifici e documenti di ricerca pubblicati su questo studio clinico:Altri ID dello studio
- HRÜ724.09.54
Numero NCT
Data di inizio (effettiva)
2025-05-12
Ultimo aggiornamento pubblicato
2026-03-25
Data di completamento (stimata)
2026-04-30
Arruolamento (previsto)
40
Tipo di studio
Interventistico
FASE
N.D.
Stato
Attivo, non in arruolamento
Parole chiave
Salivary Alpha-Amylase
Root Canal Treatment
Randomized Controlled Trial
Root Canal Treatment
Randomized Controlled Trial
Scopo principale
Altro
Allocazione
Randomizzato
Modello di intervento
In parallelo
Mascheramento
Singolo
Bracci / Interventi
| Gruppo/Braccio di partecipanti | Intervento/Trattamento |
|---|---|
SperimentaleExperimental 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...Mostra di più |
Nessun interventoControl 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. | N.D. |
Esito primario
Esito secondario
| Misure di esito | Descrizione della misura | Arco temporale |
|---|---|---|
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) |
| Misure di esito | Descrizione della misura | Arco temporale |
|---|---|---|
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) |
Assistente alla partecipazione
Criteri di eleggibilità
Età idonea
Adulto, Adulto anziano
Età minima
18 Years
Sessi idonei
Tutti
- 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 BaşkanParte responsabile dello studio
Beyhan Başkan, Promotore-investigatore, Assistant Professor, Kahramanmaras Sutcu Imam University
Nessun dato di contatto
1 Centri dello studio in 1 paesi
Kahramanmaraş Sütçü İmam Universty, Kahramanmaraş, 46140, Turkey (Türkiye)