Intraoral Cryotherapy in Root Canal Retreatment

Cryotherapy Effect Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05091554
• Other study ID #: IzmirKCUekarataslioglu
• Status: Completed
• Phase: N/A
• Start date: April 1, 2019
• Est. completion date: March 14, 2020

Study information

• Verified date: November 2021
• Source: Izmir Katip Celebi University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 118
• Est. completion date: March 14, 2020
• Est. primary completion date: June 14, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Cryotherapy Effect
• Periodontitis

Intervention

Procedure:
• intraoral 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.

Locations

Country	Name	City	State
Turkey	Izmir Katip Celebi University	Izmir

Sponsors (1)

Lead Sponsor	Collaborator
Izmir Katip Celebi University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Levels of postoperative pain	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.	6 hours
Primary	Levels of postoperative pain	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.	24 hours
Primary	Levels of postoperative pain	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.	72 hours
Primary	Levels of postoperative pain	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.	1 week
Secondary	Rate of analgesic use	Comparison of analgesic use in groups	1 week