The Success Rate of Cryotherapy Application in Primary Molars With Signs of Irreversible Pulpitis

March 2, 2022 updated by: Ahmad Elheeny, Minia University

The Success Rate of Cryotherapy Application in Primary Molars With Signs of Irreversible

The study is designed as a randomized controlled trial with two parallel groups. Children aged 5-9 years with primary molars from suffered symptomatic signs of irreversible pulpitis will be randomly assigned into two groups. The first group (experimental group) will be injected with 4% articaine 1:100.000 epinephrine (inferior alveolar nerve block). For the second group, the mandibular second primary molars will be anesthetized using 4% articaine 1:100.000 epinephrine using inferior alveolar nerve block.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

188

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 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

5 years to 9 years (CHILD)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Healthy children are classified as I or II according to ASA
  • Presence of at least one mandibular primary molar with symptomatic signs of irreversible pulpitis
  • Presence of at least two-thirds of the root length in periapical radiograph

Exclusion Criteria:

  • Unrestorable crowns
  • Children with systemic, severe behavior or emotional problems
  • Presence of gingival redness, swellings, fistulous of sinus tract
  • Radiographic evidence of internal root resorption, pulp stones or calcifications, and/or bone radiolucency

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: SUPPORTIVE_CARE
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Cryotherapy during inferior alveolar nerve block
Other: Cryotherapy
local anesthetic injection with articaine 4% 1:100,000 epinephrine then an application ice packs
ACTIVE_COMPARATOR: Inferior alveolar nerve block
Other: Traditional local anesthesia
local anesthetic injection with articaine 4% 1:100,000 epinephrine

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain assessment
Time Frame: up to 24 hours
Wong Backer pain scale
up to 24 hours

Collaborators and Investigators

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

Sponsor

Minia 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 (ANTICIPATED)

February 22, 2022

Primary Completion (ANTICIPATED)

April 30, 2022

Study Completion (ANTICIPATED)

April 30, 2022

Study Registration Dates

First Submitted

February 22, 2022

First Submitted That Met QC Criteria

March 2, 2022

First Posted (ACTUAL)

March 4, 2022

Study Record Updates

Last Update Posted (ACTUAL)

March 4, 2022

Last Update Submitted That Met QC Criteria

March 2, 2022

Last Verified

March 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 133

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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