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Clinical Trials/NCT05091554
NCT05091554
Completed
Not Applicable

Effect of Intraoral Cryotherapy Application on Postoperative Pain in Nonsurgical Endodontic Retreatment of Teeth With Apical Periodontitis: A Randomized Clinical Trial

Izmir Katip Celebi University1 site in 1 country118 target enrollmentApril 1, 2019

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Cryotherapy Effect
Sponsor
Izmir Katip Celebi University
Enrollment
118
Locations
1
Primary Endpoint
Levels of postoperative pain
Status
Completed
Last Updated
4 years ago

Overview

Brief Summary

The aim of this study was to evaluate the effect of intraoral cryotherapy application on postoperative pain in single and multiple visit retreatment of teeth with symptomatic or asymptomatic apical periodontitis. This clinical trial was also investigate the potential of intraoral cryotherapy application to reduce on postoperative analgesic use of patients in line with the results obtained.

A total of 118 patients who met the inclusion criteria were selected for the study. The patients were randomly divided into two groups as single visit and multiple visit (n=59). Then, each group was randomly divided into three subgroups as control (without cryotherapy), 15 minutes of cryotherapy, and 30 minutes of cryotherapy. Twenty two teeth were retreated in each cryotherapy group and 15 teeth in each control group. Visual analogue scale (VAS) was used to evaluate and compare postoperative pain. Postoperative analgesic use of patients was also recorded.

Registry
clinicaltrials.gov
Start Date
April 1, 2019
End Date
March 14, 2020
Last Updated
4 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Izmir Katip Celebi University
Responsible Party
Principal Investigator
Principal Investigator

emrah karataslioglu

Assoc. Prof. Dr.

Izmir Katip Celebi University

Eligibility Criteria

Inclusion Criteria

  • 18 and 65 year-old patients.
  • Patients with pre-treated teeth diagnosed with symptomatic or asymptomatic apical periodontitis.
  • Patients who can tolerate the treatment physically and mentally.

Exclusion Criteria

  • The presence of any systemic disease,
  • the presence of any allergic reactions or pregnancy,
  • use of any analgesic or antibiotic medication within 7 days,
  • use of corticosteroid within 6 months,
  • severe periodontal disease (periodontal pockets \>3 mm) in the pretreated tooth,
  • surgical endodontic treatment,
  • having drainage,
  • periapical index (PAI) score 1 and 2,
  • excessively curved, excessively long or short roots, calcified or resorbed root canals,
  • immature apices,

Outcomes

Primary Outcomes

Levels of postoperative pain

Time Frame: 1 week

The primary endpoint in calculating the sample size was to obtain visual analog scale (VAS) values. The intensity of postoperative pain was 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 Outcomes

  • Rate of analgesic use(1 week)

Study Sites (1)

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