Status:
RECRUITING
The Effect of Cryotherapy on the Outcome of Pulpotomy and Root Canal Treatment
Lead Sponsor:
Ondokuz Mayıs University
Conditions:
Pulpitis
Caries; Dentin
Eligibility:
All Genders
18-65 years
Phase:
NA
Brief Summary
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 treat...
Detailed Description
Sample Size Determination Method and Total Number of Subjects for the Study: The study will span 24 months, and a total of 144 patients meeting the inclusion criteria will be selected from those seek...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 13 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2025
Estimated Enrollment :
144 Patients enrolled
Trial Details
Trial ID
NCT06183021
Start Date
December 13 2023
End Date
December 1 2025
Last Update
April 24 2024
Active Locations (1)
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1
Ondokuz Mayıs University Dp. Endodontics, Faculty of Dentistry
Samsun, Turkey (Türkiye), 55400