Cryotherapy's impact on dental treatments for pulpitis and caries
The Effect of Cryotherapy on the Outcome of Pulpotomy and Root Canal Treatment of Deep Dentinal Caries: a Randomized Clinical Trial.
This study is testing if using cold therapy during dental treatments for tooth decay can help reduce pain and improve recovery for patients with deep cavities.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 144 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Ondokuz Mayıs University Academic / other |
| Locations | 1 site (Samsun) |
| Trial ID | NCT06183021 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to evaluate the effectiveness of cryotherapy in enhancing the outcomes of total pulpotomy and root canal treatments for patients with deep dentin caries. It involves four experimental groups: two receiving cryotherapy and two serving as control groups without cryotherapy. The study will assess postoperative pain, quality of life, and overall treatment success over a 24-month period with a total of 144 participants. Patients will be selected based on specific inclusion criteria, including age and dental health status, and will undergo various assessments to determine eligibility.
Who should consider this trial
Good fit: Ideal candidates are systemically healthy adults aged 18-65 with upper or lower jaw molars affected by deep dentin caries.
Not a fit: Patients with chronic systemic diseases, necrotic teeth, or those with extensive dental damage may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved pain management and treatment outcomes for patients undergoing dental procedures for pulpitis and caries.
How similar studies have performed: While the use of cryotherapy in dental treatments is not widely established, preliminary studies suggest potential benefits, making this approach relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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 of the relevant tooth being immature
Where this trial is running
Samsun
- Ondokuz Mayıs University Dp. Endodontics, Faculty of Dentistry — Samsun, Turkey (Recruiting)
Study contacts
- Principal investigator: Cangül Keskin, PhD — Ondokuz Mayıs University
- Study coordinator: Cangül Keskin, PhD
- Email: cangul.keskin@omu.edu.tr
- Phone: 0905414203909
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.