- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT07703553
Comparing Pre-Anesthetic Approaches in Dentistry
Comparison of Pre-Anesthetic Approaches to Reduce Needle Insertion Pain Before Dental Local Anesthesia.
The main purpose of this study is to find out which pre-treatment method works best to reduce pain from dental anesthesia injections in adult patients. Researchers will compare four different approaches:
Topical numbing spray (10% lidocaine) Brief cold application (cryotherapy) A combination of both cold application and cooled numbing spray A control group Participants who need a standard local anesthesia injection for their dental treatment will be randomly assigned to one of these four groups. Right after the needle insertion, participants will rate their pain level using a simple visual scale, and their physical reactions will also be observed and scored by the researchers.
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiesteder
-
-
Outside of the US
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Sanliurfa, Outside of the US, Tyrkiet (Türkiye), 63300
- Harran University Faculty of Dentristry,Departman of Endodonti
-
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Beskrivelse
Inclusion Criteria:
- Adults aged between 18 and 65 years. Systemically healthy individuals classified as ASA I or II. Patients presenting to the Harran University Faculty of Dentistry Hospital who require local anesthesia during dental treatment. Treatment plan requiring mandibular block anesthesia, anterior/posterior infiltration, or palatal infiltration. No regular use of analgesics (NSAIDs, paracetamol, etc.) within the last 7 days. No history of allergy to cold application or topical anesthetics.
Exclusion Criteria:
- Regular use of analgesics (NSAIDs, paracetamol, etc.) within the last 7 days. Chronic pain syndrome, migraine, or systemic diseases requiring continuous use of analgesics. Pregnancy or lactation. Presence of active lesions in the oral mucosa, severe periodontal infection, or pathology at the injection site. History of allergy to topical gel or cold application. Psychiatric disorders or conditions preventing compliance with dental treatment.
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Støttende pleje
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: Topical Anesthetic Spray
Application of 10% lidocaine spray to the oral mucosa before local anesthesia.
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Topical application of 10% lidocaine spray to reduce injection pain.
|
|
Eksperimentel: Cryotherapy
Application of an ice pen to the oral mucosa for 60 seconds before local anesthesia.
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Pre-cooling the injection site using an ice pen for 60 seconds.
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Eksperimentel: Combination Arm Type: Experimental
Application of an ice pen for 60 seconds followed by 10% lidocaine spray before local anesthesia.
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Topical application of 10% lidocaine spray to reduce injection pain.
Pre-cooling the injection site using an ice pen for 60 seconds.
|
|
Ingen indgriben: Control
Standard local anesthesia injection without any pre-anesthetic intervention.
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Pain intensity during initial needle insertion (VAS)
Tidsramme: During the initial local anesthesia needle insertion.
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Subjective pain levels will be assessed by participants using a Visual Analog Scale (VAS) ranging from 0 to 10 mm.
Higher scores indicate greater pain.
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During the initial local anesthesia needle insertion.
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Objective pain assessment using Sound-Eye-Motor (SEM) scale
Tidsramme: During the initial local anesthesia needle insertion.
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Pain levels will be assessed objectively by the researchers based on the participants' sound, eye, and motor reactions (SEM score).
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During the initial local anesthesia needle insertion.
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Samarbejdspartnere og efterforskere
Sponsor
Publikationer og nyttige links
Generelle publikationer
- 1. Chandrasekaran, J., et al., Efficacy of painless injection technique-Vibraject-Clinical trial in Chennai, India. 2014. 2. Kumar, M., R. Chawla, and M. Goyal, Topical anesthesia. Journal of Anaesthesiology Clinical Pharmacology, 2015. 31(4): p. 450-456. 3. Ghaderi, F., S. Banakar, and S. Rostami, Effect of pre-cooling injection site on pain perception in pediatric dentistry:"A randomized clinical trial". Dental research journal, 2013. 10(6): p. 790. 4. Aminabadi, N.A. and R.M.Z. Farahani, The effect of pre-cooling the injection site on pediatric pain perception during the administration of local anesthesia. The journal of contemporary dental practice, 2012. 10: p. 43-50. 5. Lakshmanan, L. and V. Ravindran, Efficacy of cryotherapy application on the pain perception during intraoral injection: a randomized controlled trial. International Journal of Clinical Pediatric Dentistry, 2021. 14(5): p. 616. 6. Wiswall, A.T., Palatal anesthesia: comparison of four techniques for decreasing injection discomfort. 2011.
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- HRÜ/26.02.87
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
IPD-planbeskrivelse
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Studerer et amerikansk FDA-reguleret enhedsprodukt
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