Effect of Cryotherapy on Post-endodontic Pain

December 22, 2023 updated by: Rania Zaarour, Gulf Medical University

Effect of Cryotherapy and Occlusal Reduction on Post-endodontic Pain in Patients With Symptomatic Apical Periodontitis

The goal of this clinical trial is to compare Cryotherapy with occlusal reduction in the reduction of post-endodontic pain in molars with symptomatic apical periodontitis. The main question it aims to answer is:

Is there is a difference in post-endodontic pain intensity following cryotherapy or occlusal reduction in patients with symptomatic apical periodontitis on mandibular first molars?

Participants will undergo root canal treatment including cryotherapy or post-operative occlusal reduction.

Researchers will compare [Cryotherapy, occlusal reduction, and no intervention] to see the intensity of post-endodontic pain.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The study will be conducted on 60 first mandibular molars; with 20 first mandibular molars in each group (n=20). The patient will be asked to pick an opaque sealed envelope that will contain a number from 1 to 3. The resultant number will determine in which group the participants will be placed. Double blinding will be maintained in this study as the operator and the patients will not be aware of their group/used root canal irrigant.

Group I : normal room temperature saline irrigation protocol without occlusal reduction.

Group II : normal room temperature saline irrigation protocol with occlusal reduction.

Group III : final irrigation with cold saline (2.5 C°- 4 C°) without occlusal reduction.

Procedural steps:

  1. Vitality will be assessed using cold tests and electric pulp testing before the procedure is carried out. Besides, mobility, palpation, and percussion tests will be done to assess periapical health. In order to ensure that the cold and electrical pulp tests are working, and a response is elicited, both tests will be carried out on patients not included in the study.
  2. All the patients will receive local anesthesia: 2% lidocaine with 1:100,000 epinephrine.
  3. Each tooth will be isolated using a rubber dam, and the access cavity will be prepared using a round bur (no.4) and tapered fissure diamond bur under copious water.
  4. After removal of coronal pulp tissues using a sterile excavator, the working length will be determined with stainless steel hand K-files size #10 and the use of an apex locator and confirmed using intraoral periapical radiographs.
  5. Hand instrumentation to 15-size K files.
  6. All the canals will be prepared using ProTaper Gold rotary files till the master apical file F2.
  7. Apical patency will be maintained throughout the shaping procedure using the #10 file between each instrument.
  8. All the canals will be irrigated with 10 mL of 3% NaOCl between each file during the whole preparation procedure.
  9. In group I the root canals will be obturated directly after preparation.
  10. In group II occlusal reduction will be performed after root canal preparation.
  11. For group III the root canals will be irrigated for 5 min using 20 ml cryo-treated saline maintained at a temperature of 2°C-4°C.
  12. After completion of cleaning and shaping dried using appropriate size paper points and the canals will be obturated using gutta-percha, and restored by permanent composite restoration.

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  1. Age: 18-70 years
  2. A patient diagnosed with symptomatic irreversible pulpitis/acute apical periodontitis
  3. require endodontic therapy
  4. Mandibular first molars that are diagnosed with symptomatic irreversible pulpitis/acute apical periodontitis
  5. Healthy patients without systemic disease
  6. Permanent mature first mandibular molars

Exclusion Criteria:

  1. Medically compromised patients
  2. Pregnant patients
  3. Teeth with incomplete apex formation
  4. Teeth with calcified canals
  5. Periapical abscess
  6. Patients on antibiotic therapy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Cryotherapy
Final irrigation with cold saline (2.5C-4C) without occlusal reduction
Procedure: Cryotherapy
Final irrigation with cold saline (2.5C-4C) without occlusal reduction
Active Comparator: Occlusal reduction
Normal room temperature saline irrigation protocol with occlusal reduction
Procedure: Occlusal reduction
Reduction of the functional and non-functional cusps
No Intervention: Control
Normal room temperature saline irrigation protocol without occlusal reduction

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The level of post-endodontic pain
Time Frame: 6 hours
Evaluation of the pain intensity using the Visual Analogue Scale. The Visual Analogue Scale measures pain intensity. The Visual Analogue Scale consists of a 10cm line, with two endpoints representing 0 ('no pain') and 10 ('pain as bad as it could possibly be)
6 hours
The level of post-endodontic pain
Time Frame: 24 hours
Evaluation of the pain intensity using the Visual Analogue Scale. The Visual Analogue Scale measures pain intensity. The Visual Analogue Scale consists of a 10cm line, with two endpoints representing 0 ('no pain') and 10 ('pain as bad as it could possibly be)
24 hours
The level of post-endodontic pain
Time Frame: 48 hours
Evaluation of the pain intensity using the Visual Analogue Scale. The Visual Analogue Scale measures pain intensity. The Visual Analogue Scale consists of a 10cm line, with two endpoints representing 0 ('no pain') and 10 ('pain as bad as it could possibly be)
48 hours
The level of post-endodontic pain
Time Frame: 72 hours
Evaluation of the pain intensity using the Visual Analogue Scale. The Visual Analogue Scale measures pain intensity. The Visual Analogue Scale consists of a 10cm line, with two endpoints representing 0 ('no pain') and 10 ('pain as bad as it could possibly be)
72 hours
The level of post-endodontic pain
Time Frame: 7 days
Evaluation of the pain intensity using the Visual Analogue Scale. The Visual Analogue Scale measures pain intensity. The Visual Analogue Scale consists of a 10cm line, with two endpoints representing 0 ('no pain') and 10 ('pain as bad as it could possibly be)
7 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Gulf Medical University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 12, 2022

Primary Completion (Actual)

September 12, 2023

Study Completion (Actual)

December 12, 2023

Study Registration Dates

First Submitted

January 23, 2023

First Submitted That Met QC Criteria

February 1, 2023

First Posted (Actual)

February 10, 2023

Study Record Updates

Last Update Posted (Actual)

December 26, 2023

Last Update Submitted That Met QC Criteria

December 22, 2023

Last Verified

December 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB/COD/STD/14/May-2022

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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