Comparative Evaluation of the Efficacy of Intraoral Cryotherapy Versus Intracanal Cryotherapy on Postoperative Pain

September 8, 2021 updated by: Toka Mohamed Ezzat Kamel Soliman, Cairo University

Comparative Evaluation of the Efficacy of Intraoral Cryotherapy Versus Intracanal Cryotherapy on Postoperative Pain in Lower Molar Teeth With Irreversible Pulpitis and Symptomatic Apical Periodontitis Randomized Clinical Trial

The aim of this study is to clinically compare the efficacy of intraoral cryotherapy versus intracanal cryotherapy after single visit root canal therapy in lower molars with irreversible pulpitis and symptomatic apical periodontitis

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

68

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

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

20 years to 20 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

Systemically healthy patient (ASA I or II).

Mandibular first molar teeth with:

  • Preoperative sharp pain and symptomatic apical periodontitis
  • Absence or slight widening in the periodontal ligament (PDL).
  • Vital response of pulp tissue to cold pulp tester (ethyl chloride spray) .
  • Positive response to percussion test

Exclusion Criteria:

  1. Medically compromised patients.
  2. Pregnant women.
  3. Patients reporting bruxism or clenching.
  4. Patients allergic to ciprofloxacin or metronidazole.
  5. Teeth associated with acute periapical abscess and/or swelling.
  6. Greater than grade I mobility or pocket depth greater than 5mm.
  7. Size of periapical radiolucency is greater than 8 mm.
  8. No restorability: Hopeless tooth.
  9. Immature teeth.
  10. Radiographic evidence of external or internal root resorption vertical root fracture, perforation, calcification.

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: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intraoral Cryotherapy
Procedure: Intraoral Cryotherapy
small ice packs wrapped in sterile gauze placed in the mouth on the vestibular surface of the treated tooth
Active Comparator: Intracanal Cryotherapy
Procedure: Intracanal Cryotherapy
Intracanal cryotherapy technique using 2.5°C cold saline irrigation as final irrigant

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Postoperative pain assessed using Visual Analogue scale
Time Frame: 6 hours post treatment
Intensity of pain after root canal treatment will be recorded by the patient where "0= no pain, 1-3= mild pain, 4-6= moderate pain, 7-10= severe pain."
6 hours post treatment
Postoperative pain assessed using Visual Analogue scale
Time Frame: 12 hours post treatment
Intensity of pain after root canal treatment will be recorded by the patient where "0= no pain, 1-3= mild pain, 4-6= moderate pain, 7-10= severe pain."
12 hours post treatment
Postoperative pain assessed using Visual Analogue scale
Time Frame: 24 hours post treatment
Intensity of pain after root canal treatment will be recorded by the patient where "0= no pain, 1-3= mild pain, 4-6= moderate pain, 7-10= severe pain."
24 hours post treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Postoperative pain assessed using Visual Analogue scale
Time Frame: 48 hours post treatment
Intensity of pain after root canal treatment will be recorded by the patient where "0= no pain, 1-3= mild pain, 4-6= moderate pain, 7-10= severe pain."
48 hours post treatment
Postoperative pain assessed using Visual Analogue scale
Time Frame: 72 hours post treatment
Intensity of pain after root canal treatment will be recorded by the patient where "0= no pain, 1-3= mild pain, 4-6= moderate pain, 7-10= severe pain."
72 hours post treatment

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of analgesics taken by the patient
Time Frame: Up to 72 hours
Number of analgesics taken by the patient after endodontic treatment.
Up to 72 hours

Collaborators and Investigators

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

Sponsor

Cairo University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 (Anticipated)

October 1, 2021

Primary Completion (Anticipated)

October 1, 2022

Study Completion (Anticipated)

October 1, 2022

Study Registration Dates

First Submitted

September 8, 2021

First Submitted That Met QC Criteria

September 8, 2021

First Posted (Actual)

September 13, 2021

Study Record Updates

Last Update Posted (Actual)

September 13, 2021

Last Update Submitted That Met QC Criteria

September 8, 2021

Last Verified

September 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ENDO 3-3-5 8/9/2021

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

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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