Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
118 participants
INTERVENTIONAL
2019-04-01
2020-03-14
Brief Summary
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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.
Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Single visit control
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.
No interventions assigned to this group
Single visit 15 minutes cryotherapy
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.
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.
Single visit 30 minutes cryotherapy
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.
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.
Multiple visit control
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.
No interventions assigned to this group
Multiple visit 15 minutes cryotherapy
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.
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.
Multiple visit 30 minutes cryotherapy
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.
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* 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 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
18 Years
65 Years
ALL
Yes
Sponsors
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Izmir Katip Celebi University
OTHER
Responsible Party
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emrah karataslioglu
Assoc. Prof. Dr.
Principal Investigators
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emrah karataslioglu, phd
Role: PRINCIPAL_INVESTIGATOR
Izmir Katip Celebi University
sule soysal, DDS
Role: PRINCIPAL_INVESTIGATOR
Izmir Katip Celebi University
ılgın akçay, phd
Role: PRINCIPAL_INVESTIGATOR
Ege University
Locations
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Izmir Katip Celebi University
Izmir, , Turkey (Türkiye)
Countries
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Other Identifiers
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IzmirKCUekarataslioglu
Identifier Type: -
Identifier Source: org_study_id