Intraoral Cryotherapy in Root Canal Retreatment

Not Applicable

Completed

• Conditions: Cryotherapy Effect

• Registration Number: NCT05091554
• Lead Sponsor: Izmir Katip Celebi University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-04-01
• Primary Completion: 2019-06-14
• Study Completion: 2020-03-14
• Study First Submitted: 2021-09-28
• Study First Submitted QC: 2021-10-12
• Study First Posted: 2021-10-25
• Status Verified: 2021-11
• Last Update Submitted: 2021-11-02
• Last Update Posted: 2021-11-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 118

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Levels of postoperative pain	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 Outcome Measures

Name	Time	Method
Rate of analgesic use	1 week	Comparison of analgesic use in groups

Trial Locations

Locations (1)

Izmir Katip Celebi University; 🇹🇷 İzmir, Turkey