The goal of this randomized clinical trial is to compare the outcome of total amputation and root canal treatment with or without cryotherapy in terms of postoperative pain, quality of life, and treatment success for the management of deep dentinal caries. The main questions it aims to answer are:
Does cryotherapy influence the outcome, life quality and treatment success in total pulpotomy? Does cryotherapy influence the outcome, life quality and treatment success in root canal treatment? Does the outcome of total pulpotomy and root canal treatment differ in cases of pulpitis?
There are 4 experimental groups:
1. Total pulpotomy with cryotherapy group
2. Total pulpotomy group (Control 1)
3. Root canal treatment with cryotherapy group
4. Root canal treatment group (Control 2)
Who can participate
Age range
18 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 in the age range of 18-65.
* Having an upper or lower jaw molar with deep dentin caries.
* No previous restorations, root canal treatments, fractures, or cracks in the relevant tooth.
* Loss of substance in the relevant tooth is limited to a Class I type, involving only the occlusal surface of the tooth.
* Obtaining a negative response to palpation and percussion.
* Normal periodontal tissues (pocket depth less than 3 mm and normal mobility).
* Exposing the pulp when the caries is completely cleaned
Exclusion Criteria:
* Having a chronic systemic disease that impedes local anaesthesia and the application of endodontic procedures.
* Presence of cracks, fractures, or restorations in the relevant tooth.
* Raynaud's phenomenon.
* Partial or total necrosis in the relevant tooth.
* Teeth with cavities other than Class I, involving more than one surface of substance loss in the relevant tooth.
* Teeth diagnosed with acute apical abscess or chronic apical abscess.
* Pregnant or breastfeeding women.
* History of allergy to materials and drugs used in treatment.
* Patients reporting spontaneous pain with a Visual Analog Scale (VAS) score of 5 or above and provoked pain lasting over 20 seconds during examination.
* Positive response to percussion and palpation.
* Advanced periodontal disease (Pocket depth greater than 3 mm and Class I or higher mobility).
* Pulp not exposed when caries is cleaned (not emerging, covered with intact dentin).
* The root apex …
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
Postoperative pain assessment
Timeframe: 1st day, 2nd day, 7th day after intervention
2
Oral health related quality of life questionnaire consisted of 14 questions
Timeframe: 1st week, 6th month after intervention
3
Treatment success based on clinical and radiographic examination