Effect of Cryotherapy on Anesthetic Success and Pain in Irreversible Pulpitis
NCT07403578 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100
Last updated 2026-02-11
Summary
This prospective randomized clinical trial aimed to evaluate the effects of different anesthesia protocols on anesthetic success and intraoperative pain during root canal treatment of mandibular premolars diagnosed with symptomatic irreversible pulpitis. A total of 100 systemically healthy patients were randomly allocated into four groups: infiltration anesthesia alone, inferior alveolar nerve block (IANB) alone, infiltration anesthesia combined with cryotherapy, and IANB combined with cryotherapy. Cryotherapy was applied intraorally for 5 minutes immediately after anesthetic administration.
The effectiveness of anesthesia was confirmed using electric pulp testing and cold testing prior to treatment. Root canal therapy was completed in a single visit by a calibrated operator. Intraoperative pain was assessed during access cavity preparation using a visual analogue scale (VAS). Anesthetic success was defined as the presence of no or mild pain, whereas moderate or severe pain indicated anesthetic failure and required supplemental anesthesia.
The primary objective of the study was to determine whether the adjunctive use of cryotherapy improves anesthetic success and reduces intraoperative pain in mandibular premolars with symptomatic irreversible pulpitis. The null hypothesis was that no significant differences would be observed among the study groups in terms of anesthetic success or intraoperative pain intensity.
Conditions
- Irreversible Pulpitis
- Cryotherapy
Interventions
- PROCEDURE
-
infiltration anesthesia alone
Local anesthesia was achieved using buccal infiltration with 2% lidocaine and 1:100,000 epinephrine.
- PROCEDURE
-
mandibular anesthesia alone
Local anesthesia was achieved using mandibular block anesthesia with 2% lidocaine and 1:100,000 epinephrine.
- PROCEDURE
-
infiltration anesthesia combined with cryotherapy
Cryotherapy was applied immediately after completion of the anesthetic injection. Small ice packs wrapped in sterile gauze were placed intraorally on the buccal vestibular surface adjacent to the treated mandibular premolar. Patients were instructed to keep the ice pack in position for 5 minutes. In cases where extreme cold sensation or burning discomfort was reported, patients were asked to remove the ice pack for 1 minute before reapplication
- PROCEDURE
-
mandibular anesthesia combined with cryotherapy
Cryotherapy was applied immediately after completion of the anesthetic injection. Small ice packs wrapped in sterile gauze were placed intraorally on the buccal vestibular surface adjacent to the treated mandibular premolar. Patients were instructed to keep the ice pack in position for 5 minutes. In cases where extreme cold sensation or burning discomfort was reported, patients were asked to remove the ice pack for 1 minute before reapplication
Sponsors & Collaborators
-
TC Erciyes University
lead OTHER
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- SINGLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 60 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2026-01-30
- Primary Completion
- 2026-09-30
- Completion
- 2026-12-30
More Related Trials
-
Effect of Cryotreated Sodium Hypochlorite Irrigation At Different Consentrations in Mandibular First Molars
NCT06820996 ·Status: COMPLETED ·Phase: NA
-
Effect of Cryotherapy on Postoperative Pain
NCT03716635 ·Status: UNKNOWN ·Phase: NA
-
Effect of Different Modalities of Cryotherapy on Post-Operative Pain in Patients With Symptomatic Irreversible Pulpitis
NCT06304259 ·Status: COMPLETED ·Phase: NA
-
Outcomes of Pulpotomy and Root Canal Treatment in Teeth With Symptomatic Irreversible Pulpitis
NCT07375576 ·Status: RECRUITING ·Phase: NA
-
Anesthesia Techniques in Symptomatic Mandibular Molars With Irreversible Pulpitis
NCT05839093 ·Status: COMPLETED ·Phase: NA
-
Comparative Evaluation of the Efficacy of Intraoral Cryotherapy Versus Intracanal Cryotherapy on Postoperative Pain
NCT05041738 ·Status: UNKNOWN ·Phase: NA
-
Cryoanalgesia for Irreversible Pulpitis
NCT06268912 ·Status: COMPLETED ·Phase: NA
-
The Success Rate of Cryotherapy Application in Primary Molars With Signs of Irreversible Pulpitis
NCT05267847 ·Status: UNKNOWN ·Phase: NA
-
The Effect of Intra-pulpal Anesthesia With Cryotherapy on Intra-operative Pain
NCT06194721 ·Status: COMPLETED ·Phase: NA
-
Cryotherapy Efficacy During Pulp Therapy of the Mandibular First Permanent Molars in Children
NCT05441995 ·Status: UNKNOWN ·Phase: NA
-
Cryotherapy Versus Dexamethasone on Postoperative Pain in Permanent Mandibular Molars
NCT06832254 ·Status: COMPLETED ·Phase: NA
-
Effectiveness of Cryotherapy on Endodontic Pain
NCT06785753 ·Status: RECRUITING ·Phase: PHASE2
-
Effect of Different Sealers and Activation Methods on Pain
NCT06860191 ·Status: NOT_YET_RECRUITING ·Phase: PHASE4
-
Clinical and Biochemical Effects Of Cryotherapy Protocols On Mandibular Premolars With Symptomatic Apical Periodontitis
NCT07138365 ·Status: COMPLETED ·Phase: NA
-
Evaluation of Post-operative Pain After Total Pulpotomy and Root Canal Treatment
NCT05923619 ·Status: COMPLETED ·Phase: NA
-
Effect of Submucosal Cryotherapy on Postoperative Endodontic Pain
NCT06090500 ·Status: COMPLETED ·Phase: NA
-
This Clinical Trial Aims to Compare the Effectiveness of Two Intra-pulpal Cryotherapy Techniques-Endo-ice and Ice Sticks-in Decreasing Intra-operative Pain and Enhancing the Success of Local Anesthesia During Pulpectomy of Mandibular Molars With Symptomatic Irreversible Pulpitis.
NCT07264829 ·Status: NOT_YET_RECRUITING ·Phase: NA
-
Analyzing the Impact of Occlusal Reduction on the Pain Following Root Canal Therapy in Molar Teeth With and Without Pain in Turkish Patients.
NCT06953856 ·Status: COMPLETED ·Phase: NA
-
EFFECTS OF IRRIGATION NEEDLES WITH DIFFERENT DESIGNS USED DURING ENDODONTIC TREATMENT ON POSTOPERATIVE PAIN
NCT07080918 ·Status: COMPLETED ·Phase: NA
-
Effectiveness of Two Intracanal Irrigation Solutions
NCT06427070 ·Status: NOT_YET_RECRUITING ·Phase: NA
-
Influence of Intra-Canal Cryotherapy on Post-Endodontic Pain and Interleukin-6 Expression Using Different Irrigation Protocols: A Randomized Clinical Trial
NCT04324398 ·Status: COMPLETED ·Phase: NA
-
Effect of Apical Patency and Local Corticosteroid on Pain and Neuropeptides Release in Patients With Symptomatic Irreversible Pulpitis: A Randomized Clinical Trial
NCT06457828 ·Status: RECRUITING ·Phase: NA
-
Two Approaches in Enhancing the Efficacy of Inferior Alveolar Nerve Block During Treatment of Mandibular First Permanent Molars With Symptomatic Irreversible Pulpitis
NCT05427903 ·Status: UNKNOWN ·Phase: NA
-
The Effect of Intra Oral Cryotherapy in Patients With Symptomatic Apical Periodontitis
NCT06082479 ·Status: COMPLETED ·Phase: NA
-
Postoperative Pain After İntracanal Procedures
NCT04892355 ·Status: UNKNOWN ·Phase: NA