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Search / Trial NCT06183021

The Effect of Cryotherapy on the Outcome of Pulpotomy and Root Canal Treatment

Launched by ONDOKUZ MAYIS UNIVERSITY · Dec 13, 2023

Trial Information

Current as of July 23, 2025

Recruiting

Keywords

Vital Pulp Treatment Cryotherapy Quality Of Life

ClinConnect Summary

This clinical trial is studying how cryotherapy, which is a treatment involving cold temperatures, affects the outcomes of two dental procedures: total pulpotomy and root canal treatment. Both procedures are used to treat deep tooth decay, but the trial aims to see if using cryotherapy can reduce pain after the treatment, improve the quality of life for patients, and increase the success rate of these treatments. Participants will be divided into four groups: one receiving total pulpotomy with cryotherapy, one with total pulpotomy without cryotherapy, one receiving root canal treatment with cryotherapy, and one without cryotherapy.

To be eligible for this trial, participants should be between 18 and 65 years old and have a specific type of tooth decay in a molar tooth that has not been previously treated or damaged. They should also not have any serious health issues that could complicate the procedures. If you join the trial, you’ll be closely monitored to see how well the treatment works and how much pain you experience afterward. This research is important because it could help improve dental treatments and patient comfort in the future.

Gender

ALL

Eligibility 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

About Ondokuz Mayıs University

Ondokuz Mayıs University is a prestigious academic institution located in Turkey, renowned for its commitment to advancing medical research and education. As a clinical trial sponsor, the university leverages its cutting-edge facilities and a multidisciplinary team of experts to conduct innovative studies that aim to enhance patient care and contribute to scientific knowledge. With a focus on ethical standards and rigorous methodologies, Ondokuz Mayıs University is dedicated to fostering collaborations that drive breakthroughs in healthcare, ultimately improving treatment outcomes and patient well-being.

Locations

Samsun, , Turkey

Patients applied

0 patients applied

Trial Officials

Cangül Keskin, PhD

Principal Investigator

Ondokuz Mayıs University

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported