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

Sponsor

Ain Shams University (Other)

Overall Status

Completed

CT.gov ID

NCT06082479

Collaborator

(none)

Enrollment

Location

Arms

Actual Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Post Operative Pain Inflammation	Procedure: intraoral cryotherapy,ice gel	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

20 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

This study was designed to be a randomized, controlled, single-blinded, single-center clinical trial.This study was designed to be a randomized, controlled, single-blinded, single-center clinical trial.

Masking:

Double (Investigator, Outcomes Assessor)

Masking Description:

A) Sequence generation;was done using a random sequence number generated by computer software. B) Allocation Concealment Mechanism: Folded, numbered papers were placed in tightly sealed envelopes containing the patient's coding

Primary Purpose:

Treatment

Official Title:

"The Effect of Intra Oral Cryotherapy on Post Operative Pain and the Level ofSubstancs P in Patients With Symptomatic Apical Periodontitis: A Randomized Clinical Trial"

Actual Study Start Date :

Sep 1, 2022

Actual Primary Completion Date :

Feb 1, 2023

Actual Study Completion Date :

Feb 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
No Intervention: control group no application of any type of cryotherapy.
Active Comparator: cryotherapy group 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.	Procedure: intraoral cryotherapy,ice gel A 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. Each cold pack was kept for ten minutes.3 packs were used for each patient, for a total time of 30 minutes.Patients were instructed to remove the cold pack for 1-2 minutes if they felt extreme cold or a burning sensation .The temperature of the gel was checked by a digital thermometer (Brannan, UK) after it was removed from the freezer and kept in an ice box (Cosmoplast, UAE) containing a cooling gel (Exam Packaging, Belgium). Other Names: cold therapy,ice pack

Arm

Intervention/Treatment

No Intervention: control group

no application of any type of cryotherapy.

Active Comparator: cryotherapy group

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.

Procedure: intraoral cryotherapy,ice gel

A 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. Each cold pack was kept for ten minutes.3 packs were used for each patient, for a total time of 30 minutes.Patients were instructed to remove the cold pack for 1-2 minutes if they felt extreme cold or a burning sensation .The temperature of the gel was checked by a digital thermometer (Brannan, UK) after it was removed from the freezer and kept in an ice box (Cosmoplast, UAE) containing a cooling gel (Exam Packaging, Belgium).

Other Names:

cold therapy,ice pack

Outcome Measures

Primary Outcome Measures

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

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion criteria:

clinical diagnosis of symptomatic apical periodontitis related to ving a mandibular single-rooted premolars
radigraphically: absence of periapical radiolucency on x ray.