Intraoral Cryotherapy on Anesthetic Efficacy in Mandibular Incisors

NCT07517367 | Recruiting Phase 4

• 1 other identifier: 124R132
• Study Type: interventional
• Target: 98
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Symptomatic Irreversible Pulpitis (SIP)

Keywords

Symptomatic Irreversible Pulpitis; Mandibular Incisor; Intraoral Cryotherapy; Buccal Infiltration Anesthesia

Outcome Measures

Primary Outcomes (2)

• Anesthetic Success Rate During Endodontic Treatment

  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.

  During pulpectomy procedure (up to 30 minutes after anesthesia)

• Anesthetic success rate

  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.

  During intervention

Secondary Outcomes (2)

• Intraoperative Pain During Pulpectomy

  During pulpectomy procedure

• Pain intensity during pulp extirpation

  During pulp extirpation

Other Outcomes (2)

• Need for Supplemental Anesthesia

  During pulpectomy procedure

• Oral Mucosal Temperature Changes

  From baseline to approximately 5 minutes after intervention

Study Arms (7)

Buccal Infiltration With Vasoconstrictor

NO INTERVENTION

Participants will receive buccal infiltration anesthesia using 2.0 mL lidocaine with epinephrine administered to the vestibular sulcus of the target mandibular incisor. Anesthetic efficacy will be evaluated using electric pulp testing and patient-reported pain scores during endodontic treatment.

Buccal Infiltration Without Vasoconstrictor

NO INTERVENTION

Participants will receive buccal infiltration anesthesia using 2.0 mL lidocaine without vasoconstrictor administered to the vestibular sulcus of the target mandibular incisor. Anesthetic success will be assessed using electric pulp testing and intraoperative pain scoring.

Buccal and Lingual Infiltration With Vasoconstrictor

NO INTERVENTION

Participants will receive both buccal and lingual infiltration anesthesia using lidocaine with epinephrine administered to the vestibular and lingual aspects of the mandibular incisor. Anesthetic efficacy will be evaluated using electric pulp testing and patient-reported pain scores.

Buccal and Lingual Infiltration Without Vasoconstrictor

NO INTERVENTION

Participants will receive buccal and lingual infiltration anesthesia using lidocaine without vasoconstrictor administered to the vestibular and lingual regions of the mandibular incisor. Pain response and anesthetic success will be recorded during treatment.

Buccal Infiltration With Vasoconstrictor and Cryotherapy

EXPERIMENTAL

Participants will receive intraoral cryotherapy applied to the vestibular sulcus for approximately 5 minutes followed by buccal infiltration anesthesia using lidocaine with epinephrine. Anesthetic success and pain response will be assessed during endodontic procedures.

Other: Cryotherapy

Buccal Infiltration Without Vasoconstrictor and Cryotherapy

EXPERIMENTAL

Participants will receive intraoral cryotherapy applied to the vestibular sulcus for approximately 5 minutes followed by buccal infiltration anesthesia using lidocaine without vasoconstrictor. Pain levels and anesthetic success will be recorded.

Other: Cryotherapy

Buccal and Lingual Infiltration With Cryotherapy

EXPERIMENTAL

Participants will receive intraoral cryotherapy followed by buccal and lingual infiltration anesthesia using lidocaine with epinephrine. Anesthetic efficacy will be evaluated using electric pulp testing and patient-reported pain scores during treatment.

Other: Cryotherapy

Interventions

Cryotherapy OTHER

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.

Buccal Infiltration With Vasoconstrictor and Cryotherapy; Buccal Infiltration Without Vasoconstrictor and Cryotherapy; Buccal and Lingual Infiltration With Cryotherapy

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ondokuz Mayıs University: lead

Study Sites (1)

Ondokuz Mayıs University

Samsun, Atakum, Turkey (Türkiye)

RECRUITING

MeSH Terms

Interventions

Cryotherapy

Intervention Hierarchy (Ancestors)

Therapeutics

Central Study Contacts

Cangül Keskin, PhD DDS

CONTACT

0905414203909; cangul.keskin@omu.edu.tr

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof

Model Details: Participants diagnosed with symptomatic irreversible pulpitis in mandibular incisor teeth will be randomly assigned to one of seven parallel groups using a computer-generated randomization sequence. Each group will receive a different intervention protocol consisting of buccal infiltration anesthesia alone, buccal plus lingual infiltration anesthesia, or buccal infiltration combined with intraoral cryotherapy, with or without vasoconstrictor-containing local anesthetic solutions.

Study Record Dates

• First Submitted: March 25, 2026
• First Posted: April 8, 2026
• Study Start: December 31, 2025
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): August 30, 2026
• Last Updated: April 8, 2026

Record last verified: 2026-04

Locations

TU (1)