Intraoral Cryotherapy in Root Canal Retreatment

NCT05091554 | Completed

• 1 other identifier: IzmirKCUekarataslioglu
• Study Type: interventional
• Target: 118
• Locations: 1 country
• Sites: 1

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.

Conditions

Cryotherapy Effect

Keywords

analgesic; cryotherapy; periapical periodontitis; postoperative pain; retreatment

Outcome Measures

Primary Outcomes (4)

• 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

• 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

• 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

• 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 Outcomes (1)

• Rate of analgesic use

  1 week

Study Arms (6)

Single visit control

NO INTERVENTION

The root canals were obturated in the same session using cold lateral compaction technique with AH Plus sealer (Dentsply DeTrey, Konstanz, Germany), Protaper Universal gutta-percha (ProTaper Universal gutta-percha, Dentsply) and .02 tapered auxiliary gutta-percha (Diadent, Chongju, Korea) cones. Residual gutta-perchas in the access cavity were removed with the aid of heated hand tools. The quality of root canal filling was checked with periapical radiographs. The pulp chamber was filled with flowable composite resin (Filtek Ultimate Flowable, 3M-ESPE, St. Paul, MN, USA) and nanohybrid composite resin (3M-ESPE) using an incremental technique. Intraoral cryotherapy was not applied.

Single visit 15 minutes cryotherapy

EXPERIMENTAL

The root canals were obturated in the same session using cold lateral compaction technique with AH Plus sealer (Dentsply DeTrey, Konstanz, Germany), Protaper Universal gutta-percha (ProTaper Universal gutta-percha, Dentsply) and .02 tapered auxiliary gutta-percha (Diadent, Chongju, Korea) cones. Residual gutta-perchas in the access cavity were removed with the aid of heated hand tools. The quality of root canal filling was checked with periapical radiographs. The pulp chamber was filled with flowable composite resin (Filtek Ultimate Flowable, 3M-ESPE, St. Paul, MN, USA) and nanohybrid composite resin (3M-ESPE) using an incremental technique. 15 minutes intraoral cryotherapy was applied.

Procedure: intraoral ice pack application

Single visit 30 minutes cryotherapy

EXPERIMENTAL

The root canals were obturated in the same session using cold lateral compaction technique with AH Plus sealer (Dentsply DeTrey, Konstanz, Germany), Protaper Universal gutta-percha (ProTaper Universal gutta-percha, Dentsply) and .02 tapered auxiliary gutta-percha (Diadent, Chongju, Korea) cones. Residual gutta-perchas in the access cavity were removed with the aid of heated hand tools. The quality of root canal filling was checked with periapical radiographs. The pulp chamber was filled with flowable composite resin (Filtek Ultimate Flowable, 3M-ESPE, St. Paul, MN, USA) and nanohybrid composite resin (3M-ESPE) using an incremental technique. 30 minutes intraoral cryotherapy was applied.

Procedure: intraoral ice pack application

Multiple visit control

NO INTERVENTION

Root canals were filled with calcium hydroxide paste (Kalsin, Turkey), prepared according to the rate recommended by the manufacturer using a lentulo spiral (Dentsply Sirona, Switzerland) 2 mm from the working length. Sterile dry cotton pellets were placed in the pulp chamber, then the access cavity was sealed with a temporary filling material and occlusion was checked. Intraoral cryotherapy was not applied. Patients were given an appointment 7 days later for second visit. In this appointment, patients were anesthetized, the tooth was isolated with rubber dam, the temporary filling material was removed. Then calcium hydroxide paste was removed by using the last instrument used to prepare the root canals at the working length during the first appointment using sufficient irrigation. The final irrigation protocol was repeated. Root canal fillings and permanent restorations were completed by applying the same techniques as in single session groups.

Multiple visit 15 minutes cryotherapy

EXPERIMENTAL

Root canals were filled with calcium hydroxide paste (Kalsin, Turkey), prepared according to the rate recommended by the manufacturer using a lentulo spiral (Dentsply Sirona, Switzerland) 2 mm from the working length. Sterile dry cotton pellets were placed in the pulp chamber, then the access cavity was sealed with a temporary filling material and occlusion was checked. 15 minutes intraoral cryotherapy was applied. Patients were given an appointment 7 days later for second visit. In this appointment, patients were anesthetized, the tooth was isolated with rubber dam, the temporary filling material was removed. Then calcium hydroxide paste was removed by using the last instrument used to prepare the root canals at the working length during the first appointment using sufficient irrigation. The final irrigation protocol was repeated. Root canal fillings and permanent restorations were completed by applying the same techniques as in single session groups.

Procedure: intraoral ice pack application

Multiple visit 30 minutes cryotherapy

EXPERIMENTAL

Root canals were filled with calcium hydroxide paste (Kalsin, Turkey), prepared according to the rate recommended by the manufacturer using a lentulo spiral (Dentsply Sirona, Switzerland) 2 mm from the working length. Sterile dry cotton pellets were placed in the pulp chamber, then the access cavity was sealed with a temporary filling material and occlusion was checked. 30 minutes intraoral cryotherapy was applied. Patients were given an appointment 7 days later for second visit. In this appointment, patients were anesthetized, the tooth was isolated with rubber dam, the temporary filling material was removed. Then calcium hydroxide paste was removed by using the last instrument used to prepare the root canals at the working length during the first appointment using sufficient irrigation. The final irrigation protocol was repeated. Root canal fillings and permanent restorations were completed by applying the same techniques as in single session groups.

Procedure: intraoral ice pack application

Interventions

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.

Multiple visit 15 minutes cryotherapy; Multiple visit 30 minutes cryotherapy; Single visit 15 minutes cryotherapy; Single visit 30 minutes cryotherapy

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Izmir Katip Celebi University: lead

Study Sites (1)

Izmir Katip Celebi University

Izmir, 35620, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Periapical Periodontitis; Pain, Postoperative

Condition Hierarchy (Ancestors)

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

Study Officials

• emrah karataslioglu, phd

  Izmir Katip Celebi University

  PRINCIPAL INVESTIGATOR

• sule soysal, DDS

  Izmir Katip Celebi University

  PRINCIPAL INVESTIGATOR

• ılgın akçay, phd

  Ege University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assoc. Prof. Dr.

Study Record Dates

• First Submitted: September 28, 2021
• First Posted: October 25, 2021
• Study Start: April 1, 2019
• Primary Completion: June 14, 2019
• Study Completion: March 14, 2020
• Last Updated: November 10, 2021

Record last verified: 2021-11

Locations

TU (1)