search
Back to results

Intraoral Cryotherapy in Root Canal Retreatment

Primary Purpose

Cryotherapy Effect

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
intraoral ice pack application
Sponsored by
Izmir Katip Celebi University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cryotherapy Effect focused on measuring analgesic, cryotherapy, periapical periodontitis, postoperative pain, retreatment

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Izmir Katip Celebi University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm Type

No Intervention

Experimental

Experimental

No Intervention

Experimental

Experimental

Arm Label

Single visit control

Single visit 15 minutes cryotherapy

Single visit 30 minutes cryotherapy

Multiple visit control

Multiple visit 15 minutes cryotherapy

Multiple visit 30 minutes cryotherapy

Arm Description

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.

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.

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.

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.

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.

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.

Outcomes

Primary Outcome Measures

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.
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.
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.
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.

Secondary Outcome Measures

Rate of analgesic use
Comparison of analgesic use in groups

Full Information

First Posted
September 28, 2021
Last Updated
November 2, 2021
Sponsor
Izmir Katip Celebi University
search

1. Study Identification

Unique Protocol Identification Number
NCT05091554
Brief Title
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

2. Study Status

Record Verification Date
November 2021
Overall Recruitment Status
Completed
Study Start Date
April 1, 2019 (Actual)
Primary Completion Date
June 14, 2019 (Actual)
Study Completion Date
March 14, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Izmir Katip Celebi University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cryotherapy Effect
Keywords
analgesic, cryotherapy, periapical periodontitis, postoperative pain, retreatment

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
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.
Allocation
Randomized
Enrollment
118 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Single visit control
Arm Type
No Intervention
Arm Description
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.
Arm Title
Single visit 15 minutes cryotherapy
Arm Type
Experimental
Arm Description
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.
Arm Title
Single visit 30 minutes cryotherapy
Arm Type
Experimental
Arm Description
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.
Arm Title
Multiple visit control
Arm Type
No Intervention
Arm Description
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.
Arm Title
Multiple visit 15 minutes cryotherapy
Arm Type
Experimental
Arm Description
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.
Arm Title
Multiple visit 30 minutes cryotherapy
Arm Type
Experimental
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
intraoral ice pack application
Intervention Description
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.
Primary Outcome Measure Information:
Title
Levels of postoperative pain
Description
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.
Time Frame
6 hours
Title
Levels of postoperative pain
Description
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.
Time Frame
24 hours
Title
Levels of postoperative pain
Description
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.
Time Frame
72 hours
Title
Levels of postoperative pain
Description
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.
Time Frame
1 week
Secondary Outcome Measure Information:
Title
Rate of analgesic use
Description
Comparison of analgesic use in groups
Time Frame
1 week

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
emrah karataslioglu, phd
Organizational Affiliation
Izmir Katip Celebi University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
sule soysal, DDS
Organizational Affiliation
Izmir Katip Celebi University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
ılgın akçay, phd
Organizational Affiliation
Ege University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Izmir Katip Celebi University
City
İzmir
ZIP/Postal Code
35620
Country
Turkey

12. IPD Sharing Statement

Learn more about this trial

Intraoral Cryotherapy in Root Canal Retreatment

We'll reach out to this number within 24 hrs