RecruitingNot ApplicableNCT06183021

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

The Effect of Cryotherapy on the Outcome of Pulpotomy and Root Canal Treatment of Deep Dentinal Caries: a Randomized Clinical Trial.

Sponsor

Ondokuz Mayıs University

Enrollment

144 participants

Start Date

Dec 13, 2023

Study Type

INTERVENTIONAL

Conditions

Pain, Postoperative Pulpitis Caries; Dentin

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 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)

Eligibility

Min Age: 18 YearsMax Age: 65 Years

Inclusion Criteria7

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 Criteria13

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

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Interventions

PROCEDUREVital pulp cryotherapy

Shaved ice made from sterile distilled water will be applied around the treated tooth especially in contact with amputated pulp tissue until totally dissolves.

PROCEDUREIntracanal cryotherapy

After mechanical preparation, a 5-minute final irrigation with 20 mL cold saline (2.5 Centigrade degrees) will be applied using a negative pressure irrigation technique per canal.