- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT07697300
COMT, MAOA, and SLC6A4 Polymorphisms and Inferior Alveolar Nerve Block Success
The Relationship Between COMT, MAOA, and SLC6A4 Polymorphisms and the Success of Inferior Alveolar Nerve Block
Studieoversikt
Status
Intervensjon / Behandling
Studietype
Registrering (Faktiske)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiesteder
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Istanbul
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Istanbul, Istanbul, Tyrkia (Türkiye), 34854
- Faculty of Dentistry, Marmara University
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Barn
- Voksen
Tar imot friske frivillige
Beskrivelse
Inclusion Criteria:
Age between 15 and 60 years. American Society of Anesthesiologists (ASA) Physical Status I. Clinical diagnosis of symptomatic irreversible pulpitis in a mandibular molar requiring primary root canal treatment.
Positive response to both the cold test and electric pulp test before treatment.
Presence of pulpal bleeding upon access cavity preparation, confirming pulp vitality.
Periodontal probing depth ≤3 mm. Sufficient coronal tooth structure to allow rubber dam isolation. No use of nonsteroidal anti-inflammatory drugs (NSAIDs) within 12 hours before enrollment.
No known allergy or hypersensitivity to articaine or epinephrine. No history of systemic or genetic disease. Ability and willingness to provide written informed consent.
Exclusion Criteria:
Previous endodontic treatment of the study tooth. Extensive coronal destruction preventing rubber dam isolation. Internal or external root resorption. Periodontal probing depth >3 mm. Pregnancy or breastfeeding. Known allergy or hypersensitivity to articaine or epinephrine. Use of nonsteroidal anti-inflammatory drugs (NSAIDs) within 12 hours before enrollment.
Presence of any systemic or genetic disease. Inability or unwillingness to provide written informed consent.
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Grunnvitenskap
- Tildeling: N/A
- Intervensjonsmodell: Enkeltgruppeoppdrag
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
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Eksperimentell: Standard Inferior Alveolar Nerve Block
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A standardized inferior alveolar nerve block was administered using 4% articaine with epinephrine to patients with symptomatic irreversible pulpitis in mandibular molars.
Fifteen minutes after injection, pulpal anesthesia was evaluated using cold and electric pulp tests.
Participants who continued to respond to either test were considered to have unsuccessful pulpal anesthesia and were excluded from the study.
Root canal treatment was initiated in participants who showed no response to both tests.
Pain experienced during treatment was assessed using the Heft-Parker Visual Analog Scale (HP-VAS).
Anesthetic success was defined as an HP-VAS score of less than 54 mm, whereas an HP-VAS score of 54 mm or greater was considered anesthetic failure.
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Success of Inferior Alveolar Nerve Block Anesthesia
Tidsramme: During root canal treatment.
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Anesthetic success was defined as an HP-VAS score of less than 54 mm during access cavity preparation and root canal treatment in patients with symptomatic irreversible pulpitis.
An HP-VAS score of 54 mm or greater was considered anesthetic failure.
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During root canal treatment.
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Samarbeidspartnere og etterforskere
Sponsor
Etterforskere
- Hovedetterforsker: Nevin kartal, Prof.Dr, Marmara University Faculty of Dentistry
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 25.09.2025/2025-66
Plan for individuelle deltakerdata (IPD)
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