Effect of Cryotherapy on Postoperative Pain in Vital Pulp Treatment of Molar Teeth

NCT ID: NCT06644703

Last Updated: 2024-10-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

62 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-09-01

Study Completion Date

2024-07-30

Brief Summary

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The goal of this clinical trial was to evaluate the effect of cryotherapy with salin solution on the intensity of postoperative pain after total pulpotomy procedures in molar teeth with symptomatic irreversible pulpitis. The main question it aims to answer is:

\- Does controlled irrigation with cold saline in total pulpotomy reduce the severity of postoperative pain? In the cryotherapy group, unlike the control group, after hemostasis was achieved, the coronal pulp cavity was irrigated with 2 °C saline solution for 5 minutes.

Detailed Description

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Conditions

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Pulpitis - Irreversible

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

SINGLE

Participants

Study Groups

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Cryotherapy group

After the coronal pulp tissue was completely removed up to the root canal orifice with a high-speed sterile diamond bur under water cooling, hemostasis was achieved within 8 minutes using a cotton pellet moistened with 1% NaOCl. The pulpotomy area was irrigated with 2 °C saline solution for 5 minutes. Then, the pulp chamber was covered with 2-3 mm thick Bio MTA+ (Cerkamed Company, Poland) and composite restoration of the teeth (Clearfil Majesty Posterior, Kuraray Medical Inc, Tokyo, Japan) was completed in the same visit.

Group Type EXPERIMENTAL

Cryotherapy

Intervention Type OTHER

The pulpotomy area was irrigated with 2 °C saline solution for 5 minutes in cryotherapy group.

Control group

After the coronal pulp tissue was completely removed up to the root canal orifice with a high-speed sterile diamond bur under water cooling, hemostasis was achieved within 8 minutes using a cotton pellet moistened with 1% NaOCl. Then, the pulp chamber was covered with 2-3 mm thick Bio MTA+ (Cerkamed Company, Poland) and composite restoration of the teeth (Clearfil Majesty Posterior, Kuraray Medical Inc, Tokyo, Japan) was completed in the same visit.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Cryotherapy

The pulpotomy area was irrigated with 2 °C saline solution for 5 minutes in cryotherapy group.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

Teeth with

* moderate or severe pain
* diagnosed with symptomatic irreversible pulpitis
* no tenderness to percussion and palpation
* positive response to cold test and electric pulp test
* no signs of periapical pathology

Exclusion Criteria

Teeth which

* could not be restored or required post-core
* had periapical lesions,
* had poor periodontal status (pocket depth\> 4 mm),
* had negative responses to pulp sensitivity tests,
* had no pulp exposure after caries removing Patients who
* had no preoperative pain or had mild preoperative pain
* had bleeding disorders
* had systemic diseases such as immunosuppressive disease or diabetes
Minimum Eligible Age

14 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Cukurova University

OTHER

Sponsor Role lead

Responsible Party

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Kübra Gürler

Cukurova University, Faculty of Dentistry

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Hamdi Oğuz Yoldaş, DDS PHD

Role: STUDY_DIRECTOR

Cukurova University

Locations

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Çukurova Üniversitesi Diş Hekimliği Fakültesi, Gültepe, Sarıçam/Adana/Türkiye

Adana, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

References

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Akhil VS, Kumar V, Aravind A, Sharma R, Sharma S, Chawla A, Upadhyay AD, Logani A. Novel cryotherapy technique for pulpotomy in mature permanent teeth with symptomatic irreversible pulpitis- a randomized controlled trial. Clin Oral Investig. 2024 Apr 26;28(5):275. doi: 10.1007/s00784-024-05661-y.

Reference Type BACKGROUND
PMID: 38668793 (View on PubMed)

Keskin C, Ozdemir O, Uzun I, Guler B. Effect of intracanal cryotherapy on pain after single-visit root canal treatment. Aust Endod J. 2017 Aug;43(2):83-88. doi: 10.1111/aej.12175. Epub 2016 Oct 4.

Reference Type BACKGROUND
PMID: 27699913 (View on PubMed)

Other Identifiers

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10.05.2025/144

Identifier Type: -

Identifier Source: org_study_id

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