Cryotherapy: 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.
Study 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
Sex
ALL
Min age
18 Years
Max age
60 Years
Healthy volunteers
No
Inclusion Criteria:
* 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 Criteria:
* 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
Primary outcome measure(s)
Anesthetic Success Rate During Endodontic Treatment — During pulpectomy procedure (up to 30 minutes after anesthesia) Anesthetic success will be defined as the absence of moderate or severe pain during pulpectomy procedures. Pain intensity will be assessed using Numerical Rating Scale (NRS). Anesthetic failure will be recorded if the participant reports moderate to severe pain, requires supplemental anesthesia, or shows positive response to electric pulp testing.
Anesthetic success rate — During intervention Anesthetic success will be defined as the absence of moderate or severe pain during pulpectomy procedures. Pain intensity will be assessed using Wong-Baker FACES scale. Anesthetic failure will be recorded if the participant reports moderate to severe pain, requires supplemental anesthesia, or shows positive response to electric pulp testing.
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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