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

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: Postoperative Pain
• Intervention / Treatment: Procedure: Intraoral Cryotherapy; Procedure: Intracanal Cryotherapy

• Study Type: Interventional
• Enrollment (Anticipated): 68
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Toka M Ezzat, B.D.S. (Cairo University); Phone Number: 002 01005137002; Email: toka.ezzat@dentistry.cu.edu.eg

Participation Criteria

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

How is the study designed?

Design Details

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

Number of Arms

2

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	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	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	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	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	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	Number of analgesics taken by the patient after endodontic treatment.	Up to 72 hours

Collaborators and Investigators

• Sponsor: Cairo University

Publications and helpful links

General Publications

• Fayyad DM, Abdelsalam N, Hashem N. Cryotherapy: A New Paradigm of Treatment in Endodontics. J Endod. 2020 Jul;46(7):936-942. doi: 10.1016/j.joen.2020.03.019. Epub 2020 May 6.
• Gundogdu EC, Arslan H. Effects of Various Cryotherapy Applications on Postoperative Pain in Molar Teeth with Symptomatic Apical Periodontitis: A Preliminary Randomized Prospective Clinical Trial. J Endod. 2018 Mar;44(3):349-354. doi: 10.1016/j.joen.2017.11.002. Epub 2018 Feb 3.

Study record dates

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: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative
• 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