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

NCT06183021 | Recruiting DMC

• 1 other identifier: 5502
• Study Type: interventional
• Target: 144
• Locations: 1 country
• Sites: 1

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 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. 1.Total pulpotomy with cryotherapy group
2. 2.Total pulpotomy group (Control 1)
3. 3.Root canal treatment with cryotherapy group
4. 4.Root canal treatment group (Control 2)

Conditions

Pulpitis; Caries; Dentin; Pain, Postoperative

Keywords

vital pulp treatment; cryotherapy; quality of life

Outcome Measures

Primary Outcomes (3)

• Postoperative pain assessment

  Postoperative pain will be assessed using visual analogue scale with a 10 cm straight line with one end meaning no pain (0) and the other end meaning the worst pain imaginable (10) and anchor markings at each millimeter

  1st day, 2nd day, 7th day after intervention

• Oral health related quality of life questionnaire consisted of 14 questions

  Oral health related quality of life scale will be applied

  1st week, 6th month after intervention

• Treatment success based on clinical and radiographic examination

  The periapical health and tooth/pulp survival

  1st week, 3rd month, 6th month

Study Arms (4)

Total pulpotomy with cryotherapy

EXPERIMENTAL

Total coronal amputation will be performed using vital pulp cryotherapy

Procedure: Vital pulp cryotherapy

Total pulpotomy

NO INTERVENTION

Total coronal amputation will be performed.

Root canal treatment with cryotherapy

EXPERIMENTAL

Orthograde root canal treatment will be performed with intracanal cryotherapy.

Procedure: Intracanal cryotherapy

Root canal treatment

NO INTERVENTION

Orthograde root canal treatment will be performed.

Interventions

Vital pulp cryotherapy PROCEDURE

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

Total pulpotomy with cryotherapy

Intracanal cryotherapy PROCEDURE

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.

Root canal treatment with cryotherapy

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ondokuz Mayıs University: lead

Study Sites (1)

Ondokuz Mayıs University Dp. Endodontics, Faculty of Dentistry

Samsun, 55400, Turkey (Türkiye)

RECRUITING

Related Publications (3)

• Duncan HF, El-Karim I, Dummer PMH, Whitworth J, Nagendrababu V. Factors that influence the outcome of pulpotomy in permanent teeth. Int Endod J. 2023 Mar;56 Suppl 2:62-81. doi: 10.1111/iej.13866. Epub 2022 Nov 22.

  PMID: 36334098 BACKGROUND

• Elmsmari F, Ruiz XF, Miro Q, Feijoo-Pato N, Duran-Sindreu F, Olivieri JG. Outcome of Partial Pulpotomy in Cariously Exposed Posterior Permanent Teeth: A Systematic Review and Meta-analysis. J Endod. 2019 Nov;45(11):1296-1306.e3. doi: 10.1016/j.joen.2019.07.005. Epub 2019 Sep 10.

  PMID: 31515048 BACKGROUND

• Cushley S, Duncan HF, Lappin MJ, Tomson PL, Lundy FT, Cooper P, Clarke M, El Karim IA. Pulpotomy for mature carious teeth with symptoms of irreversible pulpitis: A systematic review. J Dent. 2019 Sep;88:103158. doi: 10.1016/j.jdent.2019.06.005. Epub 2019 Jun 20.

  PMID: 31229496 BACKGROUND

MeSH Terms

Conditions

Pulpitis; Pain, Postoperative

Condition Hierarchy (Ancestors)

Dental Pulp Diseases; Tooth Diseases; Stomatognathic Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Study Officials

• Cangül Keskin, PhD

  Ondokuz Mayıs University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Cangül Keskin, PhD

CONTACT

0905414203909; cangul.keskin@omu.edu.tr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor

Model Details: Parallel assignment

Study Record Dates

• First Submitted: December 13, 2023
• First Posted: December 27, 2023
• Study Start: December 13, 2023
• Primary Completion: January 1, 2025
• Study Completion: December 1, 2025
• Last Updated: April 24, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)