Using intraoral cold to improve numbness in lower front teeth
Official title: Evaluation of the Effect of Intraoral Cryotherapy on Anesthetic Efficacy in Mandibular Incisor Teeth With Irreversible Pulpitis
Run by Ondokuz Mayıs University · NCT07517367 · Data updated 2026-11-12
This trial will see if applying cold inside the mouth helps buccal infiltration anesthesia work better for adults with symptomatic irreversible pulpitis in a lower front tooth.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years to 60 Years |
| Sex | All |
| Enrollment | 98 (estimated) |
| Sponsor | Ondokuz Mayıs University Academic / other |
| Locations | 1 site (Samsun, Atakum) |
| Status | Recruiting |
| Started | December 31, 2025 |
| Main results expected | August 1, 2026 |
| Study ends | August 30, 2026 |
| Registry record updated | April 8, 2026 |
| Trial ID | NCT07517367 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults aged 18–60 with symptomatic irreversible pulpitis in a single-rooted mandibular incisor, ASA I–II, high preoperative pain, no radiographic periapical pathology, and the ability to consent and complete pain assessments.
✕Probably not a fit
Patients who are pregnant, have uncontrolled diabetes, Raynaud disease, thyroid or adrenal disorders, radiographic periapical pathology, multi-rooted teeth, or who fall outside the 18–60 age range are excluded and unlikely to benefit from this intervention.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This randomized clinical trial enrolls adults with symptomatic irreversible pulpitis in a single-rooted mandibular incisor and compares buccal infiltration anesthesia alone, buccal infiltration plus intraoral cryotherapy, and the use of supplemental lingual infiltration as needed. Cryotherapy involves local cold application inside the mouth before or during anesthetic delivery to reduce nerve conduction and local inflammation. Primary outcomes include anesthetic success measured by pain scores, responses to pulp testing, and the need for supplemental injections during endodontic treatment. The goal is to determine whether adding intraoral cryotherapy can improve pain control and reduce the requirement for additional injections in mandibular incisor anesthesia.
Why it matters
Potential benefit: If successful, this approach could improve numbness for lower front teeth and reduce the need for extra or more invasive injections during root canal treatment.
How similar studies have gone: Previous work showed intraoral cryotherapy improved inferior alveolar nerve block success in mandibular molars, but using cryotherapy to boost infiltration anesthesia in mandibular incisors is novel and untested clinically.
Who can join: the full rules
Show full inclusion / exclusion 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 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
Where it's running
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Ondokuz Mayıs University
Samsun, Atakum, Turkey (Türkiye) Recruiting
Study contacts
- Study coordinator: Cangül Keskin, PhD DDS
- Email: cangul.keskin@omu.edu.tr
- Phone: 0905414203909
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.