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

Sponsor

Minia University (Other)

Overall Status

Recruiting

CT.gov ID

NCT05267847

Collaborator

(none)

188

Enrollment

Location

Arms

2.2

Anticipated Duration (Months)

85.4

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Pain, Procedural	Other: Cryotherapy Other: Traditional local anesthesia	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

188 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Supportive Care

Official Title:

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

Anticipated Study Start Date :

Feb 22, 2022

Anticipated Primary Completion Date :

Apr 30, 2022

Anticipated Study Completion Date :

Apr 30, 2022

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Pain assessment [up to 24 hours]
Wong Backer pain scale

Eligibility Criteria

Criteria

Ages Eligible for Study:

5 Years to 9 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Omar Ahmed	Al Minyā		Egypt	61111

Sponsors and Collaborators

Minia University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Ahmad Elheeny, Assistant Professor, Minia University

ClinicalTrials.gov Identifier:

NCT05267847

Other Study ID Numbers:

First Posted:

Mar 4, 2022

Last Update Posted:

Mar 4, 2022

Last Verified:

Mar 1, 2022

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Pain, Procedural

Anesthetics

Study Results

No Results Posted as of Mar 4, 2022