Intraoral Cryotherapy on Cytokine Levels and Postoperative Endodontic Pain
The Effect of Intraoral Cryotherapy on the Change of Inflammatory Cytokine Levels and Postoperative Endodontic Pain in Teeth With Apical Periodontitis
1 other identifier
interventional
30
1 country
1
Brief Summary
The aim of this study is to evaluate the effects of intraoral cryotherapy on the inflammatory cytokine levels during root canal treatment and postoperative pain intensity and incidence. Mandibular premolar teeth of 30 patients diagnosed with asymptomatic apical periodontitis will be included to the study for this purpose. The experimental protocols consist clinical and laboratory phases. In clinical phase, procedures of cryotherapy and control groups will be applied in 2-visit-root canal treatment. The samples, which were collected during root canal treatment, will be subjected to enzyme-linked immunosorbent assay (ELISA) analysis in laboratory. Levels of interleukin and inflammatory destructive enzymes will be determined in collected samples. During the analysis of visual analogue scale scores, the correlation between the changes of the cytokine and proteolytic enzyme levels and presence and intensity of pain will be evaluated.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Aug 2021
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 19, 2021
CompletedStudy Start
First participant enrolled
August 19, 2021
CompletedFirst Posted
Study publicly available on registry
August 23, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 23, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
September 19, 2022
CompletedSeptember 21, 2022
September 1, 2022
1 year
August 19, 2021
September 19, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
1.Change of proinflammatory cytokine levels
The samples are collected from periapical exudate at the end of the first and second visit of root canal treatment. The samples are analyzed with high sensitive ELISA method and change of proinflammatory cytokines from first and second visit will be evaluated in ng/ml or pg/ml.
12 months
2.Levels of postoperative pain
The intensity of postoperative pain will be 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.
12 months
Study Arms (2)
Cryotherapy group
EXPERIMENTALAn intraoral ice pack will be placed on the mucosal groove during root canal treatment.
Control group
PLACEBO COMPARATORNo ice pack will be used.
Interventions
Eligibility Criteria
You may qualify if:
- Being systemically healthy,
- Signing the consent form,
- Having a single-rooted tooth diagnosed with asymptomatic apical periodontitis, -No pre-made restoration, no root canal treatment, no fractures or cracks in the tooth
You may not qualify if:
- Not being systemically healthy,
- Not giving consent to the study,
- Presence of cracks, fractures, restorations in the relevant tooth,
- History of Raynaud's phenomenon
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Ondokuz Mayıs University Dp. Endodontics, Faculty of Dentistry
Samsun, 55400, Turkey (Türkiye)
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor
Study Record Dates
First Submitted
August 19, 2021
First Posted
August 23, 2021
Study Start
August 19, 2021
Primary Completion
August 23, 2022
Study Completion
September 19, 2022
Last Updated
September 21, 2022
Record last verified: 2022-09
Data Sharing
- IPD Sharing
- Will not share