Intraoral Cryotherapy on Anesthetic Efficacy in Mandibular Incisors
Evaluation of the Effect of Intraoral Cryotherapy on Anesthetic Efficacy in Mandibular Incisor Teeth With Irreversible Pulpitis
Ondokuz Mayıs University
98 participants
Dec 31, 2025
INTERVENTIONAL
Conditions
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
Inclusion Criteria9
- 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
Exclusion Criteria13
- Age below 18 years or above 60 years
- Pregnancy
- Known allergy to local anesthetic agents
- Diagnosis of diabetes mellitus
- Presence of hypothyroidism
- Diagnosis of adrenal insufficiency
- Presence of Raynaud disease
- Uncontrolled diabetes (HbA1c >7%)
- Presence of periapical pathology detected radiographically
- Presence of sinus tract
- Presence of intraoral or extraoral swelling
- Teeth diagnosed with necrotic pulp
- Presence of referred pain from another tooth or anatomical structure
Interested in this trial?
Get notified about updates and connect with the research team.
Interventions
Intraoral cryotherapy will be applied using small ice packs wrapped in sterile gauze and placed into the vestibular sulcus adjacent to the target mandibular incisor. Participants will be instructed to maintain the ice pack in position for approximately 5 minutes prior to the anesthetic procedure. If discomfort occurs, participants will be allowed to briefly remove the ice pack and reapply it once comfort is restored. This intervention is intended to induce local vasoconstriction and reduce nerve conduction to enhance anesthetic efficacy.
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT07517367