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NCT Number: NCT05091554

Intraoral Cryotherapy in Root Canal Retreatment

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.

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Key information

Conditions

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

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Izmir Katip Celebi University

Izmir, 35620, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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,
  • complications like perforation, overfilling, broken files

Treatment and study plan

intraoral ice pack application

Procedure

Tap water was filled into plastic ice molds and kept in the freezer in the clinic until the application was made. The ice packs used were weighed with digital pocket scale (Knmaster CT1000, Turkey) as 6-8 grams. In the cryotherapy groups, at the end of the first appointment ice packs were removed from the freezer, wrapped in sterile gauze and placed on the vestibular mucosa of the teeth.

Primary outcomes

  1. Levels of postoperative pain

    Time frame: 6 hours

    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.

  2. Levels of postoperative pain

    Time frame: 24 hours

    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.

  3. Levels of postoperative pain

    Time frame: 72 hours

    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.

  4. 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

  1. Rate of analgesic use

    Time frame: 1 week

    Comparison of analgesic use in groups

Sponsors and collaborators

Lead sponsor

Izmir Katip Celebi University

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2019
Study completion
2020
First posted
Oct 25, 2021
Registry last updated
Nov 10, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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