Intraoral Cryotherapy on Anesthetic Efficacy in Mandibular Incisors

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

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.

Study Overview

• Status: Recruiting
• Conditions: Symptomatic Irreversible Pulpitis (SIP)
• Intervention / Treatment: Other: Cryotherapy

Detailed Description

Achieving profound pulpal anesthesia in mandibular anterior teeth with symptomatic irreversible pulpitis remains a significant clinical challenge. Inflammation within the pulp tissue lowers the pain threshold and alters the local tissue environment, reducing the effectiveness of conventional local anesthetic techniques. Buccal infiltration anesthesia alone may be insufficient in mandibular incisors due to accessory innervation and anatomical variations, often necessitating supplemental techniques such as lingual infiltration or intraligamentary injections. However, repeated injections may increase patient discomfort and anxiety, highlighting the need for effective, non-pharmacological adjunctive methods to enhance anesthetic success.

Cryotherapy is a non-toxic, non-pharmacological method that has been widely used in medicine for its anti-inflammatory and analgesic effects. Local cold application induces vasoconstriction, reduces nerve conduction velocity, and limits inflammatory responses, thereby potentially enhancing anesthetic efficacy. Previous studies have demonstrated that intraoral cryotherapy can improve the success of inferior alveolar nerve block anesthesia in mandibular molars with irreversible pulpitis. However, there is currently no clinical evidence evaluating the effectiveness of intraoral cryotherapy in improving infiltration anesthesia success in mandibular incisor teeth diagnosed with irreversible pulpitis.The present randomized clinical study aims to compare the anesthetic efficacy of intraoral cryotherapy and supplemental lingual infiltration when used in conjunction with buccal infiltration anesthesia in mandibular incisors with symptomatic irreversible pulpitis. Additionally, the study evaluates whether intraoral cryotherapy can serve as an alternative to supplemental lingual infiltration for improving anesthetic success. The study also investigates the effect of vasoconstrictor-containing and vasoconstrictor-free local anesthetic solutions on anesthetic outcomes.

Eligible participants diagnosed with symptomatic irreversible pulpitis in mandibular central or lateral incisors are randomly assigned to one of seven experimental groups receiving different combinations of buccal infiltration, lingual infiltration, and intraoral cryotherapy, with or without vasoconstrictor-containing anesthetic solutions. Pain levels are assessed using a combination of Numerical Rating Scale (NRS) and Wong-Baker FACES scale during anesthetic administration and endodontic treatment procedures. Anesthetic success is determined based on patient-reported pain levels, electric pulp testing results, and the need for supplemental anesthesia. Additionally, thermal imaging is used to evaluate temperature changes in oral mucosa following anesthetic and cryotherapy applications, providing objective data on vasoconstriction and tissue response.

This study is expected to provide clinical evidence regarding the effectiveness of intraoral cryotherapy as an adjunctive method for improving anesthetic success in mandibular incisors with irreversible pulpitis. The findings may contribute to the development of safer, less invasive anesthetic protocols that improve patient comfort and reduce the need for multiple injections during endodontic emergency treatment.

• Study Type: Interventional
• Enrollment (Estimated): 98
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Cangül Keskin, PhD DDS; Phone Number: 0905414203909; Email: cangul.keskin@omu.edu.tr

Study Locations

• Turkey (Türkiye)
  • Atakum
    • Samsun, Atakum, Turkey (Türkiye)
      • Recruiting
      • Ondokuz Mayıs University
      • Contact: Cangül Keskin, PhD DDS; Phone Number: 8254 03623121919; Email: cangul.keskin@omu.edu.tr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

7

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Buccal Infiltration With Vasoconstrictor; 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.
No Intervention: Buccal Infiltration Without Vasoconstrictor; 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.
No Intervention: Buccal and Lingual Infiltration With Vasoconstrictor; 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.
No Intervention: Buccal and Lingual Infiltration Without Vasoconstrictor; 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.
Experimental: Buccal Infiltration With Vasoconstrictor and Cryotherapy; 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; 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.
Experimental: Buccal Infiltration Without Vasoconstrictor and Cryotherapy; 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; 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.
Experimental: Buccal and Lingual Infiltration With Cryotherapy; 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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Intraoperative Pain During Pulpectomy	Pain intensity experienced during pulpectomy will be recorded using the Numerical Rating Scale (NRS) at any stage of treatment before pulp extirpation.	During pulpectomy procedure
Pain intensity during pulp extirpation	Pain intensity experienced during pulpectomy will be recorded using the Wong-Baker FACES scale at any stage of treatment before pulp extirpation.	During pulp extirpation

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Need for Supplemental Anesthesia	The requirement for additional intraligamentary anesthesia during treatment will be recorded as an indicator of anesthetic failure.	During pulpectomy procedure
Oral Mucosal Temperature Changes	Changes in oral mucosal surface temperature following anesthetic and/or cryotherapy application will be measured using thermal imaging. The lowest recorded temperature and duration of temperature change will be analyzed.	From baseline to approximately 5 minutes after intervention

Collaborators and Investigators

• Sponsor: Ondokuz Mayıs University

Study record dates

Study Major Dates

• Study Start (Actual): December 31, 2025
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): August 30, 2026

Study Registration Dates

• First Submitted: March 25, 2026
• First Submitted That Met QC Criteria: April 3, 2026
• First Posted (Actual): April 8, 2026

Study Record Updates

• Last Update Posted (Actual): April 8, 2026
• Last Update Submitted That Met QC Criteria: April 3, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Symptomatic Irreversible Pulpitis; Mandibular Incisor; Intraoral Cryotherapy; Buccal Infiltration Anesthesia
• Additional Relevant MeSH Terms: Therapeutics; Cryotherapy
• Other Study ID Numbers: 124R132 (Other Grant/Funding Number: Scientific and Technological Research Council of Türkiye)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: Individual participant data sharing has not yet been determined. Data sharing policies will be evaluated after study completion in accordance with institutional regulations, ethical approvals, and applicable data protection laws.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No