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Cryotherapy on Inflammatory Profile and Postoperative Pain Levels in Endodontic Infections

Primary Purpose

Apical Periodontitis, Postoperative Pain, Cytokine Levels

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Distilled water irrigation kept at 2.5°C degree
Distilled water irrigation kept at room temperature
Sponsored by
Ondokuz Mayıs University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Apical Periodontitis focused on measuring Endodontics infections, Interleukin, Intracanal cryotherapy

Eligibility Criteria

20 Years - 30 Years (Adult)MaleAccepts Healthy Volunteers

Inclusion Criteria:

  • Being systemically healthy, Being a male, Being in the age range of 20-30, Signing the consent form, Having a single lower premolar tooth diagnosed with asymptomatic apical periodontitis, No pre-made restoration, no root canal treatment, no fractures or cracks in the tooth

Exclusion Criteria:

  • Not being systemically healthy, Not giving consent to the study, Presence of cracks, fractures, restorations in the relevant tooth, Raynaud's phenomenon

Sites / Locations

  • Ondokuz Mayıs University Dp. Endodontics, Faculty of Dentistry

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Cryotherapy group

Control group

Arm Description

Final canal irrigation will be done for 5 minutes with 20 mL of distilled water kept at 2.5°C in the refrigerator using EndoVac negative pressure irrigation system.

Final canal irrigation will be done for 5 minutes with 20 mL of distilled water kept at room temperature in the refrigerator using EndoVac negative pressure irrigation system.

Outcomes

Primary Outcome Measures

Change of proinflammatory cytokine
The samples are collected from periapical exudate at the end of the first and second visit of root canal treatment. The samples are analyzed with high sensitive ELISA method and change of proinflammatory cytokines from first and second visit will be evaluated in ng/ml or pg/ml.
Levels of postoperative pain
The intensity of postoperative pain will be evaluated with visual analogue scale, which is a 10 cm line representing a continuum of pain levels between "no pain" on the left side and "most severe pain" on the right side between 0 and 10.

Secondary Outcome Measures

Full Information

First Posted
March 5, 2021
Last Updated
June 9, 2022
Sponsor
Ondokuz Mayıs University
Collaborators
The Scientific and Technological Research Council of Turkey
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1. Study Identification

Unique Protocol Identification Number
NCT04798144
Brief Title
Cryotherapy on Inflammatory Profile and Postoperative Pain Levels in Endodontic Infections
Official Title
Evaluation of the Effect of Intracanal Cryotherapy Applications on the Inflammatory Cytokine and Proteolytic Enzyme Levels and Postoperative Pain of Teeth With Primary Endodontic Infections
Study Type
Interventional

2. Study Status

Record Verification Date
June 2022
Overall Recruitment Status
Completed
Study Start Date
November 15, 2020 (Actual)
Primary Completion Date
March 31, 2022 (Actual)
Study Completion Date
April 15, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ondokuz Mayıs University
Collaborators
The Scientific and Technological Research Council of Turkey

4. Oversight

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

5. Study Description

Brief Summary
The aim of this study is to evaluate the effects of cryotherapy applications on the inflammatory cytokine and collagenase matrix metalloproteinase levels during root canal treatment and postoperative pain intensity and incidence. Mandibular premolar teeth of 60 male patients within the 20-30 years old range, diagnosed with asymptomatic apical periodontitis will be included to the study for this purpose. The experimental protocols consist clinical and laboratory phases. In clinical phase, procedures of cryotherapy and control groups will be applied in 2-visit-root canal treatment. The samples, which were collected during root canal treatment, will be subjected to enzyme-linked immunosorbent assay (ELISA) analysis in laboratory. Levels of interleukin and inflammatory destructive enzymes will be determined in collected samples. During the analysis of visual analogue scale scores, the correlation between the changes of the cytokine and proteolytic enzyme levels and presence and intensity of pain will be evaluated.
Detailed Description
Cryotherapy is the reduction of the temperature of living tissues for therapeutic purposes. The temperature decrease that will occur as a result of cryotherapy depends on the degree of the applied tissue and agent, the application time, and the thermal permeability of the tissues and the agent . With the application of cryotherapy in human tissues, it is aimed to reduce the temperature of the host cells and control pain. There is limited data on the use of cryotherapy, which is widely used in medicine, in the field of operative dentistry. It is frequently used after surgical procedures such as cryotherapy, periodontal surgery, tooth extraction and implant application, but its first use in endodontics is to extend the cold saline solution of during root canal treatment. It has been described in laboratory studies that it reduces the external temperature of the root by applying it with apical negative pressure irrigation system for 5 minutes following the procedures. Following this in vitro study, the efficacy of different cryotherapy protocols in reducing pain after root canal treatment was reported by all of the few clinical studies. Studies reported that after endodontic treatment of teeth with symptomatic apical periodontitis, pain severity decreased after cryotherapy application and the frequency of postoperative painkiller use of patients decreased. It was reported that cryotherapy application in endodontic treatments of teeth with symptomatic irreversible pulpitis with vital pulp reduced postoperative pain severity. A laboratory study performed on extracted teeth reported that cryotherapy application reduces the vertical fracture strength of the roots, however, comprehensive laboratory and clinical studies evaluating the various physical properties of the teeth are required in order to make definitive interpretations concerning the clinic and to create a consensus.It has not been fully revealed how and by what mechanism intra-canal cryotherapy applications reduce pain. When cold is applied, a decrease in blood flow occurs in living tissues; It has been shown that neural receptors are inhibited in skin and subcutaneous tissues. Clinical studies report that cold therapy reduces acute musculoskeletal pain, muscle spasms, connective tissue strains, nerve conduction time, and hemorrhage. Cryotherapy restricts the inflammatory reactions that occur in the damaged area by causing vasoconstriction and inhibition of cellular metabolism. Vasoconstriction thus causes a decrease in edema and blockage of nerve endings with the decrease in temperature leads to a decrease in pain. Although decreasing body temperature also decreases peripheral nerve conduction, when it falls below 15 ° C, nerve conduction is completely deactivated. Tissue damage that may result from secondary hypoxia is also minimized by slowing down cell metabolism. The activities and amounts of destructive enzymes in the tissue are reduced. The analgesic effect of cryotherapy is achieved by a combination of reducing the chemical mediators of pain and slowing down neural pain signals. In addition, a 50% slowdown in metabolism has a positive effect on oxygen diffusion in damaged tissues. How intra-canal cryotherapy reduces postoperative endodontic pain has not been fully elucidated yet. When the effects of cryotherapy applications on damaged muscle and connective tissues are interpreted, a decrease in the amount of inflammatory cytokines is expected in a region where cryotherapy is applied. The amounts of inflammatory cytokines and destructive enzymes in periradicular tissues were not evaluated after intra-canal cryotherapy. Intra-canal cryotherapy stands out as a simple, economical and non-toxic pain control technique, although it eliminates the side effects that may be caused by drugs by reducing the use of painkillers after the procedure. It is a technique that should be applied rather than an alternative, especially for patients who are recommended to avoid painkiller use (drug allergy, geriatric population). It consists of washing the root canals with cold saline solution for 5 minutes, which can be easily adapted to the endodontic treatment routine. This procedure can be applied with negative pressure irrigation systems or endodontic irrigation needles used in routine irrigation. It is a more practical and controlled procedure than applying an ice pack inside or outside the mouth after the procedure, and it will be applied by the physician.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Apical Periodontitis, Postoperative Pain, Cytokine Levels
Keywords
Endodontics infections, Interleukin, Intracanal cryotherapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Cryotherapy group
Arm Type
Experimental
Arm Description
Final canal irrigation will be done for 5 minutes with 20 mL of distilled water kept at 2.5°C in the refrigerator using EndoVac negative pressure irrigation system.
Arm Title
Control group
Arm Type
Placebo Comparator
Arm Description
Final canal irrigation will be done for 5 minutes with 20 mL of distilled water kept at room temperature in the refrigerator using EndoVac negative pressure irrigation system.
Intervention Type
Device
Intervention Name(s)
Distilled water irrigation kept at 2.5°C degree
Intervention Description
The use of cold distilled water for final irrigation of root canal system during root canal treatment
Intervention Type
Device
Intervention Name(s)
Distilled water irrigation kept at room temperature
Intervention Description
The use of distilled water kept at room temperature for final irrigation of root canal system during root canal treatment
Primary Outcome Measure Information:
Title
Change of proinflammatory cytokine
Description
The samples are collected from periapical exudate at the end of the first and second visit of root canal treatment. The samples are analyzed with high sensitive ELISA method and change of proinflammatory cytokines from first and second visit will be evaluated in ng/ml or pg/ml.
Time Frame
28 months
Title
Levels of postoperative pain
Description
The intensity of postoperative pain will be evaluated with visual analogue scale, which is a 10 cm line representing a continuum of pain levels between "no pain" on the left side and "most severe pain" on the right side between 0 and 10.
Time Frame
2 months

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Being systemically healthy, Being a male, Being in the age range of 20-30, Signing the consent form, Having a single lower premolar tooth diagnosed with asymptomatic apical periodontitis, No pre-made restoration, no root canal treatment, no fractures or cracks in the tooth Exclusion Criteria: Not being systemically healthy, Not giving consent to the study, Presence of cracks, fractures, restorations in the relevant tooth, Raynaud's phenomenon
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Elif Kalyoncuoğlu, PhD
Organizational Affiliation
Ondokuz Mayıs University
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Abdurrahman Aksoy, PhD
Organizational Affiliation
Ondokuz Mayıs University
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Ayşegül Arkan, DDS
Organizational Affiliation
Ondokuz Mayıs University
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Onur Kömeç, DDS
Organizational Affiliation
Ondokuz Mayıs University
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Elçin Yüzgüleç, DDS
Organizational Affiliation
Ondokuz Mayıs University
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Hande Akgün, DDS
Organizational Affiliation
Ondokuz Mayıs University
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Sabiha G Afak, DDS
Organizational Affiliation
Ondokuz Mayıs University
Official's Role
Study Chair
Facility Information:
Facility Name
Ondokuz Mayıs University Dp. Endodontics, Faculty of Dentistry
City
Samsun
ZIP/Postal Code
55400
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
9021326
Citation
Aiba T, Akeno N, Kawane T, Okamoto H, Horiuchi N. Matrix metalloproteinases-1 and -8 and TIMP-1 mRNA levels in normal and diseased human gingivae. Eur J Oral Sci. 1996 Oct-Dec;104(5-6):562-9. doi: 10.1111/j.1600-0722.1996.tb00142.x.
Results Reference
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PubMed Identifier
32916207
Citation
Sadaf D, Ahmad MZ, Onakpoya IJ. Effectiveness of Intracanal Cryotherapy in Root Canal Therapy: A Systematic Review and Meta-analysis of Randomized Clinical Trials. J Endod. 2020 Dec;46(12):1811-1823.e1. doi: 10.1016/j.joen.2020.08.022. Epub 2020 Sep 8.
Results Reference
background
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
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Cryotherapy on Inflammatory Profile and Postoperative Pain Levels in Endodontic Infections

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