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

Primary Purpose

Post Operative Pain, Inflammation

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
intraoral cryotherapy,ice gel
Sponsored by
Ain Shams University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Post Operative Pain focused on measuring Cryotherapy, substance P, apical periodontitis, post operative pain

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion criteria: clinical diagnosis of symptomatic apical periodontitis related to ving a mandibular single-rooted premolars radigraphically: absence of periapical radiolucency on x ray. Exclusion criteria: The presence of any systemic disease or allergic reactions Vulnerable population: prisoners, pregnant women, mentally ill people, etc. Use of analgesic or antibiotic medication within three days A radiographically untraceable canal

Sites / Locations

  • Ain Shams University

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Active Comparator

Arm Label

control group

cryotherapy group

Arm Description

no application of any type of cryotherapy.

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.

Outcomes

Primary Outcome Measures

Level of post operative pain using 10 cm visual analoge scale (VAS)
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
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.

Full Information

First Posted
September 29, 2023
Last Updated
October 8, 2023
Sponsor
Ain Shams University
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1. Study Identification

Unique Protocol Identification Number
NCT06082479
Brief Title
The Effect of Intra Oral Cryotherapy in Patients With Symptomatic Apical Periodontitis
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"
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Completed
Study Start Date
September 1, 2022 (Actual)
Primary Completion Date
February 1, 2023 (Actual)
Study Completion Date
February 1, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ain Shams University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post Operative Pain, Inflammation
Keywords
Cryotherapy, substance P, apical periodontitis, post operative pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
This study was designed to be a randomized, controlled, single-blinded, single-center clinical trial.
Masking
InvestigatorOutcomes 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
Allocation
Randomized
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
control group
Arm Type
No Intervention
Arm Description
no application of any type of cryotherapy.
Arm Title
cryotherapy group
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
intraoral cryotherapy,ice gel
Other Intervention Name(s)
cold therapy,ice pack
Intervention Description
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).
Primary Outcome Measure Information:
Title
Level of post operative pain using 10 cm visual analoge scale (VAS)
Description
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.
Time Frame
after 6hours, 24hours, 48hours, 72hours h, and 7days after the visit
Secondary Outcome Measure Information:
Title
Level of inflammatory mediator substance P in apical fluid
Description
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.
Time Frame
base line: immediately after procedure.the second is 30 minutes later in both groups.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion criteria: clinical diagnosis of symptomatic apical periodontitis related to ving a mandibular single-rooted premolars radigraphically: absence of periapical radiolucency on x ray. Exclusion criteria: The presence of any systemic disease or allergic reactions Vulnerable population: prisoners, pregnant women, mentally ill people, etc. Use of analgesic or antibiotic medication within three days A radiographically untraceable canal
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Maram F Obeid, Professor
Organizational Affiliation
Faculty of Dentistry,Ain Shams University
Official's Role
Study Director
Facility Information:
Facility Name
Ain Shams University
City
Cairo
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
detailed Statistical Analysis Plan
IPD Sharing Time Frame
2025 ,available for a year
IPD Sharing Access Criteria
review the purpose of request
Citations:
PubMed Identifier
29398090
Citation
Gundogdu EC, Arslan H. Effects of Various Cryotherapy Applications on Postoperative Pain in Molar Teeth with Symptomatic Apical Periodontitis: A Preliminary Randomized Prospective Clinical Trial. J Endod. 2018 Mar;44(3):349-354. doi: 10.1016/j.joen.2017.11.002. Epub 2018 Feb 3.
Results Reference
background
PubMed Identifier
37222468
Citation
Keskin C, Aksoy A, Kalyoncuoglu E, Keles A, Ilik AA, Komec O, Yuzgulec E, Akgun H, Alak SG, Tokur O. Effect of intracanal cryotherapy on the inflammatory cytokine, proteolytic enzyme levels and post-operative pain in teeth with asymptomatic apical periodontitis: A randomized clinical trial. Int Endod J. 2023 Aug;56(8):932-942. doi: 10.1111/iej.13937. Epub 2023 May 30.
Results Reference
background
Links:
URL
https://dsu.journals.ekb.eg/article_192084.html
Description
worked on inflammatory mediators in similar matter

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

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