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Intraoral Cryotherapy in Root Canal Retreatment

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05091554
Enrollment
118
Registered
2021-10-25
Start date
2019-04-01
Completion date
2020-03-14
Last updated
2021-11-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cryotherapy Effect

Keywords

analgesic, cryotherapy, periapical periodontitis, postoperative pain, retreatment

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.

Interventions

PROCEDUREintraoral ice pack application

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.

Sponsors

Izmir Katip Celebi University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Masking description

In this study, double blindness was not possible because of the nature of the ice packs, the patients and the physician were aware of the cryotherapy groups. Therefore, patients were only blinded before the treatment procedures.

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Levels of postoperative pain6 hoursThe 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

MeasureTime frameDescription
Rate of analgesic use1 weekComparison of analgesic use in groups

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026