Cryotherapy on Inflammatory Profile and Postoperative Pain Levels in Endodontic Infections

NCT04798144 | Completed DMC

• 1 other identifier: 119S397
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Apical Periodontitis; Postoperative Pain; Cytokine Levels

Keywords

Endodontics infections; Interleukin; Intracanal cryotherapy

Outcome Measures

Primary Outcomes (2)

• 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.

  28 months

• 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.

  2 months

Study Arms (2)

Cryotherapy group

EXPERIMENTAL

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.

Device: Distilled water irrigation kept at 2.5°C degree

Control group

PLACEBO COMPARATOR

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.

Device: Distilled water irrigation kept at room temperature

Interventions

Distilled water irrigation kept at 2.5°C degree DEVICE

The use of cold distilled water for final irrigation of root canal system during root canal treatment

Cryotherapy group

Distilled water irrigation kept at room temperature DEVICE

The use of distilled water kept at room temperature for final irrigation of root canal system during root canal treatment

Control group

Eligibility Criteria

• Age: 20 Years - 30 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Ondokuz Mayıs University: lead
• The Scientific and Technological Research Council of Turkey: collaborator

Study Sites (1)

Ondokuz Mayıs University Dp. Endodontics, Faculty of Dentistry

Samsun, 55400, Turkey (Türkiye)

Location

Related Publications (3)

• 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.

  PMID: 9021326 BACKGROUND

• 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.

  PMID: 32916207 BACKGROUND

• 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.

  PMID: 29398090 BACKGROUND

MeSH Terms

Conditions

Periapical Periodontitis; Pain, Postoperative

Condition Hierarchy (Ancestors)

Periapical Diseases; Jaw Diseases; Stomatognathic Diseases; Periodontal Diseases; Mouth Diseases; Periodontitis; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Study Officials

• Elif Kalyoncuoğlu, PhD

  Ondokuz Mayıs University

  STUDY CHAIR

• Abdurrahman Aksoy, PhD

  Ondokuz Mayıs University

  STUDY CHAIR

• Ayşegül Arkan, DDS

  Ondokuz Mayıs University

  STUDY CHAIR

• Onur Kömeç, DDS

  Ondokuz Mayıs University

  STUDY CHAIR

• Elçin Yüzgüleç, DDS

  Ondokuz Mayıs University

  STUDY CHAIR

• Hande Akgün, DDS

  Ondokuz Mayıs University

  STUDY CHAIR

• Sabiha G Afak, DDS

  Ondokuz Mayıs University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: March 5, 2021
• First Posted: March 15, 2021
• Study Start: November 15, 2020
• Primary Completion: March 31, 2022
• Study Completion: April 15, 2022
• Last Updated: June 10, 2022

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)