Clinical trial NCT05091554: Intraoral Cryotherapy in Root Canal Retreatment
Official title: Effect of Intraoral Cryotherapy Application on Postoperative Pain in Nonsurgical Endodontic Retreatment of Teeth With Apical Periodontitis: A Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cryotherapy Effect
Keywords: analgesic
cryotherapy
periapical periodontitis
postoperative pain
retreatment
Lead sponsor: Izmir Katip Celebi University
Sponsor class: OTHER
First posted: 2021-10-25
Enrollment: 118
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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,
* complications like perforation, overfilling, broken files

Primary outcomes:
measure: Levels of postoperative pain
timeFrame: 6 hours
measure: Levels of postoperative pain
timeFrame: 24 hours
measure: Levels of postoperative pain
timeFrame: 72 hours
measure: Levels of postoperative pain
timeFrame: 1 week
Secondary outcomes:
measure: Rate of analgesic use
timeFrame: 1 week
Other outcomes:
Locations:
city: İzmir
country: Turkey
facility: Izmir Katip Celebi University
Study officials:
affiliation: Izmir Katip Celebi University
name: emrah karataslioglu, phd
role: PRINCIPAL_INVESTIGATOR
affiliation: Izmir Katip Celebi University
name: sule soysal, DDS
role: PRINCIPAL_INVESTIGATOR
affiliation: Ege University
name: ılgın akçay, phd
role: PRINCIPAL_INVESTIGATOR
References: