Evaluation of the Effect of Intraoral Cryotherapy on Anesthetic Efficacy in Mandibular Incisor Teeth With Irreversible Pulpitis
Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Interventional
Study Phase: Phase 4
SUMMARY
The aim is to compare the contributions of intraoral cryotherapy and supplemental lingual infiltration anesthesia to buccal infiltration anesthesia in mandibular incisor teeth with irreversible pulpitis in terms of anesthetic efficacy, and to evaluate the effect of adding intraoral cryotherapy to buccal anesthesia on anesthetic efficacy.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 60
Healthy Volunteers: f
View:
• Adults aged 18 to 60 years
• Classified as ASA Physical Status I or II
• Presence of symptomatic irreversible pulpitis in a single-rooted mandibular incisor tooth
• Preoperative pain score ≥8 on the Numerical Rating Scale (NRS) and Wong-Baker FACES scale
• Positive response to cold test and electric pulp testing
• Absence of periapical pathology on preoperative periapical radiograph
• No analgesic intake within 6 hours prior to treatment
• Ability to understand and complete pain assessment scales
• Willingness to provide written informed consent
Locations
Other Locations
Turkey
Ondokuz Mayıs University
RECRUITING
Samsun
Contact Information
Primary
Cangül Keskin, PhD DDS
cangul.keskin@omu.edu.tr
0905414203909
Time Frame
Start Date:2025-12-31
Estimated Completion Date:2026-08-30
Participants
Target number of participants:98
Treatments
No_intervention: Buccal Infiltration With Vasoconstrictor
Participants will receive buccal infiltration anesthesia using 2.0 mL lidocaine with epinephrine administered to the vestibular sulcus of the target mandibular incisor. Anesthetic efficacy will be evaluated using electric pulp testing and patient-reported pain scores during endodontic treatment.
No_intervention: Buccal Infiltration Without Vasoconstrictor
Participants will receive buccal infiltration anesthesia using 2.0 mL lidocaine without vasoconstrictor administered to the vestibular sulcus of the target mandibular incisor. Anesthetic success will be assessed using electric pulp testing and intraoperative pain scoring.
No_intervention: Buccal and Lingual Infiltration With Vasoconstrictor
Participants will receive both buccal and lingual infiltration anesthesia using lidocaine with epinephrine administered to the vestibular and lingual aspects of the mandibular incisor. Anesthetic efficacy will be evaluated using electric pulp testing and patient-reported pain scores.
No_intervention: Buccal and Lingual Infiltration Without Vasoconstrictor
Participants will receive buccal and lingual infiltration anesthesia using lidocaine without vasoconstrictor administered to the vestibular and lingual regions of the mandibular incisor. Pain response and anesthetic success will be recorded during treatment.
Experimental: Buccal Infiltration With Vasoconstrictor and Cryotherapy
Participants will receive intraoral cryotherapy applied to the vestibular sulcus for approximately 5 minutes followed by buccal infiltration anesthesia using lidocaine with epinephrine. Anesthetic success and pain response will be assessed during endodontic procedures.
Experimental: Buccal Infiltration Without Vasoconstrictor and Cryotherapy
Participants will receive intraoral cryotherapy applied to the vestibular sulcus for approximately 5 minutes followed by buccal infiltration anesthesia using lidocaine without vasoconstrictor. Pain levels and anesthetic success will be recorded.
Experimental: Buccal and Lingual Infiltration With Cryotherapy
Participants will receive intraoral cryotherapy followed by buccal and lingual infiltration anesthesia using lidocaine with epinephrine. Anesthetic efficacy will be evaluated using electric pulp testing and patient-reported pain scores during treatment.