Using intraoral cold to improve numbness in lower front teeth

Evaluation of the Effect of Intraoral Cryotherapy on Anesthetic Efficacy in Mandibular Incisor Teeth With Irreversible Pulpitis

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: PHASE4
• Study type: Interventional
• Enrollment: 98 (estimated)
• Ages: 18 Years to 60 Years
• Sex: All
• Sponsor: Ondokuz Mayıs University (other)
• Locations: 1 site (Samsun, Atakum)
• Trial ID: NCT07517367 on ClinicalTrials.gov

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.

Who should consider this trial

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.

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.

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 performed: 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.

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 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 this trial is running

Samsun, Atakum

• Ondokuz Mayıs University — Samsun, Atakum, Turkey (Türkiye) (RECRUITING)

Study contacts

• Study coordinator: Cangül Keskin, PhD DDS

Conditions: Symptomatic Irreversible Pulpitis, Mandibular Incisor, Intraoral Cryotherapy, Buccal Infiltration Anesthesia