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

NCT05041738 | Unknown

• 1 other identifier: ENDO 3-3-5 8/9/2021
• Study Type: interventional
• Target: 68
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Postoperative Pain

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (2)

• Postoperative pain assessed using Visual Analogue scale

  48 hours post treatment

• Postoperative pain assessed using Visual Analogue scale

  72 hours post treatment

Other Outcomes (1)

• Number of analgesics taken by the patient

  Up to 72 hours

Study Arms (2)

Intraoral Cryotherapy

EXPERIMENTAL

Procedure: Intraoral Cryotherapy

Intracanal Cryotherapy

ACTIVE COMPARATOR

Procedure: Intracanal Cryotherapy

Interventions

Intraoral Cryotherapy PROCEDURE

small ice packs wrapped in sterile gauze placed in the mouth on the vestibular surface of the treated tooth

Intraoral Cryotherapy

Intracanal Cryotherapy PROCEDURE

Intracanal cryotherapy technique using 2.5°C cold saline irrigation as final irrigant

Intracanal Cryotherapy

Eligibility Criteria

• Age: 20 Years - 20 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Cairo University: lead

Related Publications (2)

• 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.

  PMID: 32386857 BACKGROUND

• 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.

  PMID: 29398090 BACKGROUND

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Central Study Contacts

Toka M Ezzat, B.D.S. (Cairo University)

CONTACT

01005137002; toka.ezzat@dentistry.cu.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator, Resident at faculty of dentistry, Cairo University

Study Record Dates

• First Submitted: September 8, 2021
• First Posted: September 13, 2021
• Study Start: October 1, 2021
• Primary Completion: October 1, 2022
• Study Completion: October 1, 2022
• Last Updated: September 13, 2021

Record last verified: 2021-09