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

Primary Purpose

Pain, Procedural

Status

Recruiting

Phase

Not Applicable

Locations

Egypt

Study Type

Interventional

Intervention

Cryotherapy

Traditional local anesthesia

About this trial

This is an interventional supportive care trial for Pain, Procedural

Eligibility Criteria

5 Years - 9 Years (Child)All SexesAccepts Healthy Volunteers

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

Sites / Locations

Omar AhmedRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Cryotherapy during inferior alveolar nerve block

Inferior alveolar nerve block

Arm Description

Outcomes

Primary Outcome Measures

Pain assessment

Wong Backer pain scale

Secondary Outcome Measures

Full Information

NCT ID

NCT05267847

First Posted

February 22, 2022

Last Updated

March 2, 2022

Sponsor

Minia University

1. Study Identification

Unique Protocol Identification Number

NCT05267847

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

March 2022

Overall Recruitment Status

Recruiting

Study Start Date

February 22, 2022 (Anticipated)

Primary Completion Date

April 30, 2022 (Anticipated)

Study Completion Date

April 30, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Minia University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

Brief Summary

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Pain, Procedural

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Outcomes Assessor

Allocation

Randomized

Enrollment

188 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Cryotherapy during inferior alveolar nerve block

Arm Type

Experimental

Arm Title

Inferior alveolar nerve block

Arm Type

Active Comparator

Intervention Type

Other

Intervention Name(s)

Cryotherapy

Intervention Description

local anesthetic injection with articaine 4% 1:100,000 epinephrine then an application ice packs

Intervention Type

Other

Intervention Name(s)

Traditional local anesthesia

Intervention Description

local anesthetic injection with articaine 4% 1:100,000 epinephrine

Primary Outcome Measure Information:

Title

Pain assessment

Description

Wong Backer pain scale

Time Frame

up to 24 hours

10. Eligibility

Sex

All

Minimum Age & Unit of Time

5 Years

Maximum Age & Unit of Time

9 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Facility Information:

Facility Name

Omar Ahmed

City

Al Minyā

ZIP/Postal Code

61111

Country

Egypt

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Omar Ahmed, PhD

Phone

0020862347768

EG135.30708112400351@nies-edu.org

12. IPD Sharing Statement

Learn more about this trial

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

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