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

Not Applicable

• Conditions: Pain, Procedural

• Registration Number: NCT05267847
• Lead Sponsor: Minia University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-02-22
• Study First Submitted: 2022-02-22
• Status Verified: 2022-03
• Study First Submitted QC: 2022-03-02
• Last Update Submitted: 2022-03-02
• Study First Posted: 2022-03-04
• Last Update Posted: 2022-03-04
• Primary Completion: 2022-04-30
• Study Completion: 2022-04-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 188

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Pain assessment	up to 24 hours	Wong Backer pain scale

Trial Locations

Locations (1)

Omar Ahmed; 🇪🇬 Al Minyā, Egypt