Clinical and Biochemical Effects Of Cryotherapy Protocols On Mandibular Premolars With Symptomatic Apical Periodontitis

NCT07138365 | Completed

• 1 other identifier: 943
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 1

Brief Summary

Pain is the major reason for patients' visits to dental clinics.Medications have side effects. Treatments including cryotherapy have been suggested to prevent these side effects.This study will compare the effect of oral and intraradicular cryotherapy on the level of substance p ,post operative pain and analgesic intake in mandibular premolars with symptomatic apical periodontitis. Thirty patients with symptomatic apical periodontitis will be randomly distributed into three groups: oral,intraradicular cryotherapy and control group (n = 10). In the oral cryotherapy group application of (a cold pack of ice gel enveloped by a sealed plastic cover) will be performed for 30 minutes following the completion of canal preparation.Getting glide path by inserting K-file #10. coronal flaring will be done .The first apical fluid samples for all groups will be obtained at this step. Intra-radicular cryotherapy will be performed where normal root canal treatment will be done. Then a final flush will be done with 20 mL of cold saline 2.5°C for 10 minutes. For the control group,no application of cryotherapy will be done.Second samples will be taken after mechanical preparation for intraradicular and control ,and after 30minutes of cold application for the cryotherapy group.Levels of substance p will be measured using the ELISA test.The patients will be asked to fill out the VAS questionnaire at 6, 24, 48 and 72 h.and analgesic intake

Conditions

Post Operative Pain; Inflammation

Keywords

Cryotherapy; post operative pain; inflammation; analgesic intake

Outcome Measures

Primary Outcomes (1)

• Level of inflammatory mediator (substance P) in apical fluid

  Sterile paper point size 20 taper 2% will be inserted into the canal and placed 2 mm beyond the apex. The paper point will be left for 30 seconds to absorb sufficient amount of fluid. Paper point will be placed into an Eppendorf tube with 1 mL (pH 7.4) phosphate buffered saline and refrigerated at 10°C for later examination.After collecting samples from all patients, the samples will be evaluated by the enzyme-linked immunosorbent assay (ELISA) method.

  base line 1st sample:after glide path and coronal flaring for all groups second sample:in control group and intraradicular group taken after mechanical preparation, ,and in oral cryo group after mechanical application and 30 minutes application of cryo

Secondary Outcomes (2)

• level of post operative pain using 10 cm visual analoge scale (VAS)

  after 6hours, 24hours, 48hours, 72hours h after treatment

• Analgesic intake

  They will be contacted by telephone at 6, 12, 24, 48 and 72 hours after

Study Arms (4)

control group

NO INTERVENTION

No application of cryotherapy .Patients will receive conventional root canal treatment. Canals will be irrigated with room temperature 2.5% NaOCl. Final flush will be done with room temperature saline for 10 min.

Oral Cryo Group

ACTIVE COMPARATOR

custom made plastic pack measuring 2.5 X5 cm containing ice gel will be placed intraorally in the mouth on the vestibular surface of the treated tooth. Patients will be instructed to remove the ice pack for 2 minute if they felt extreme cold or a burning sensation. Each pack will be placed for 10 min, totaling three minimally per 30 min of intermittent application with 2-min breaks in between. During the cryotherapy treatment, a thermocouple device will be used to monitor the temperature, which Will be maintained at 10 °C. If the temperature exceeded the predetermined threshold of 10 °C, immediate replacement of the gel pack with a new one will be carried out to bring the temperature back within the desired range.

Procedure: oral Cryotherapy

Intra-Radicular Cryo Group

ACTIVE COMPARATOR

During the procedure, irrigation was performed between each rotary file using a side-vented needle (gauge size 30) positioned 2mm from the working length. This was done with 5 mL of 2.5% sodium hypochlorite (NaOCl), Followed by 5 ml of 17% EDTA (META BIOMED, Korea) for 1 min. Final flush was done with cold (2-4 oC) Saline for 10 mins.

Procedure: Intra radicular Cryotherapy

Cold Irr. group

ACTIVE COMPARATOR

Canals were irrigated with cold (2-4 oC) 2.5% NaOCl. Final flush was done with cold (2-4 oC) Saline for 10 mins.

Procedure: cold irrigation

Interventions

oral Cryotherapy PROCEDURE

custom made plastic pack measuring 2.5 X5 cm containing ice gel will be placed intraorally in the mouth on the vestibular surface of the treated tooth.

Oral Cryo Group

Intra radicular Cryotherapy PROCEDURE

Final flush was done with cold (2-4 oC) Saline for 10 mins.

Intra-Radicular Cryo Group

cold irrigation PROCEDURE

irrigation with cold (2-4 oC) 2.5% NaOCl and Final flush was done with cold (2-4 oC) Saline for 10 mins.

Cold Irr. group

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Both genders
• Eligible participants will be between the ages of 18-45
• Participants willing to commit for the entire period of the trial and agreed to sign the written consent after full explanation of the study
• Having a mandibular single rooted premolar tooth with vital pulp Vertucci Type I canal system.
• Patients that will be diagnosed with symptomatic apical periodontitis on the basis of the clinical symptoms of severe preoperative pain (visual analogue scale \[VAS\] \> 7) and severe percussion pain (VAS \> 7)
• The absence of periapical radiolucency on x ray.

You may not qualify if:

• Presence of any systemic disease or allergic reactions
• Vulnerable population: prisoners, pregnant women, mentally ill people, etc.
• Use of analgesic or antibiotic medication within seven days
• A radiographically untraceable canal
• Excessively curved root
• Excessively long or short root length
• Teeth with open apices
• A previous root canal treatment
• Sinus tracts
• Local gum swelling around the affected tooth
• Severe periodontal disease
• Presence of periodontal pockets \>3 mm in the affected tooth
• Absence of bleeding in the pulp chamber on access cavity preparation
• Problems in determining working length
• Broken files, over instrumentation, and overfilling/incomplete filling

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Ain Shams University

Cairo, Egypt

Location

Related Publications (4)

• Abdel-Baset ST, Fahmy SH, Obeid MF. Can instrumentation kinematics affect postoperative pain and substance P levels? A randomized controlled trial. BMC Oral Health. 2024 Jan 17;24(1):102. doi: 10.1186/s12903-024-03882-x.

  PMID: 38233887 BACKGROUND

• Sharaf RMA, Abdelrahman TY, Obeid MF. The impact of using cold irrigation on postoperative endodontic pain and substance P level: a randomized clinical trial. Odontology. 2025 Jun 18. doi: 10.1007/s10266-025-01131-3. Online ahead of print.

  PMID: 40533695 BACKGROUND

• Hamza EM, Abd El Aziz TM, Obeid MF. The influence of intraoral cryotherapy on postoperative pain and substance P in symptomatic apical periodontitis: randomized clinical study. Sci Rep. 2024 Jun 17;14(1):13890. doi: 10.1038/s41598-024-64071-y.

  PMID: 38880787 BACKGROUND

• Vera J, Ochoa J, Romero M, Vazquez-Carcano M, Ramos-Gregorio CO, Aguilar RR, Cruz A, Sleiman P, Arias A. Intracanal Cryotherapy Reduces Postoperative Pain in Teeth with Symptomatic Apical Periodontitis: A Randomized Multicenter Clinical Trial. J Endod. 2018 Jan;44(1):4-8. doi: 10.1016/j.joen.2017.08.038. Epub 2017 Nov 1.

  PMID: 29079057 BACKGROUND

MeSH Terms

Conditions

Pain, Postoperative; Inflammation

Interventions

Cryotherapy

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

• Maram F Obeid, Professor

  Faculty of Dentistry,Ain Shams University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 1)Patients will be assigned at random to either the intra oral group ,intra radicular group or the control group (n=10). The name of the group will be scrawled on a slip of paper and sealed inside a plain envelope. As each patient arrived for treatment, one envelope will be drawn at random from a box to assign the patient to a certain group.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: randomized, controlled, single-blinded, single- center clinical trial

Study Record Dates

• First Submitted: August 1, 2025
• First Posted: August 22, 2025
• Study Start: June 1, 2024
• Primary Completion: June 1, 2025
• Study Completion: June 1, 2025
• Last Updated: February 11, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: 2027,for a year
• Access Criteria: review purpose of request,

Locations

EG (1)