CompletedNot Applicable

Intraoral Cryotherapy on Cytokine Levels and Postoperative Endodontic Pain

Turkey (Türkiye)30 participantsStarted 2021-08-19

Plain-language 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.

Who can participate

Age range

20 Years – 65 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 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 Exclusion Criteria: * Not being systemically healthy, * Not giving consent to the study, * Presence of cracks, fractures, restorations in the relevant tooth, * History of Raynaud's phenomenon

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

1.Change of proinflammatory cytokine levels

Timeframe: 12 months

2.Levels of postoperative pain

Timeframe: 12 months

Trial details

NCT IDNCT05017064

SponsorOndokuz Mayıs University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2022-08-23

View on ClinicalTrials.gov More Apical Periodontitis trials