Intraoral Cryotherapy on Anesthetic Efficacy in Mandibular Incisors
Recruiting
Phase 4Interventional Study
Symptomatic Irreversible Pulpitis (SIP)
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
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At a Glance
Age
18 – 60
Sex
Any
Trial phase
Phase 4
Study type
Interventional
Purpose
Treatment
Participants needed
98 (estimated)
Sponsor
Ondokuz Mayıs University · Other
Who this trial is looking for
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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.
Trial Locations
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Eligibility Criteria
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…
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
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