The Effect of Intra Oral Cryotherapy in Patients With Symptomatic Apical Periodontitis

Not Applicable

Completed

• Conditions: Inflammation; Post Operative Pain
• Interventions: Procedure: intraoral cryotherapy,ice gel

• Registration Number: NCT06082479
• Lead Sponsor: Ain Shams University

Brief Summary

The participants were divided into two groups: Group I (cryotherapy) (n =10) after the completion of the mechanical preparation intra oral cryotherapy was applied. Group II (control) (n =10) received standard root canal treatment without the application of any type of cryotherapy.

Detailed Description

1-Patients selection: 20 patients with symptomatic apical peridontitis related to mandibular premolars were selected . After proper anestehsia, Access cavity preparation was performed. The working length measured using apex locator. chemicomechanical preparation was done. for cryotherapy group: cold pack (ice gel enveloped by a sealed plastic cover) measuring 2.5 x 5 centimetres was placed intraorally on the vestibular surface of the treated tooth for a total time of 30 minutes. apical fluid sample was collected by paper point and the root canal was then filled using gutta percha and resin-based sealer.The access cavity was sealed using glass ionomer restoration. for the control group normal treatment was done and apical fluid was collested also before obturation.

Study Timeline

• Study Start: 2022-09-01
• Primary Completion: 2023-02-01
• Study Completion: 2023-02-01
• Study First Submitted: 2023-09-29
• Study First Submitted QC: 2023-10-08
• Study First Posted: 2023-10-13
• Status Verified: 2024-01
• Last Update Submitted: 2024-01-29
• Last Update Posted: 2024-01-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
cryotherapy group	intraoral cryotherapy,ice gel	after the completion of the mechanical preparation. A 2.5 x5 centimetre gel pack was placed in the mouth on the vestibular surface of the treated tooth.

Primary Outcome Measures

Name	Time	Method
Level of post operative pain using 10 cm visual analoge scale (VAS)	after 6hours, 24hours, 48hours, 72hours h, and 7days after the visit	On a10-cm Visual Analogue Scale (VAS) questionnaire, each patient reported their level of pain as follows: There is no pain at 0, 1-3, mild, 4-6, moderate, 7-9, severe, and 10, the worst pain.

Secondary Outcome Measures

Name	Time	Method
Level of inflammatory mediator substance P in apical fluid	base line: immediately after procedure.the second is 30 minutes later in both groups.	Apical fluid samples were obtained using paper points size 25 passing 2 mm beyond the apex.where they were soaked by the periapical interstitial fluid for 1 minute .Four mm from the tip of each paper point was cut and dropped into 1.5-mL Eppendorf tubes (Swanscombe, UK) with 1 mL (pH 7.4) phosphate buffered saline, then stored at -80°C. Levels of substance p were measured using the ELISAtest.

Trial Locations

Locations (1)

Ain Shams University; 🇪🇬 Cairo, Egypt