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NCT05267847 Clinical Trial

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

Pain, Procedural Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT05267847
Other study ID # 133
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date February 22, 2022
Est. completion date April 30, 2022

Study information
Verified date March 2022
Source Minia University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Recruiting
Enrollment 188
Est. completion date April 30, 2022
Est. primary completion date April 30, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 5 Years to 9 Years
Eligibility 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

Related Conditions & MeSH terms

Intervention

Other:
• Cryotherapy
local anesthetic injection with articaine 4% 1:100,000 epinephrine then an application ice packs
• Traditional local anesthesia
local anesthetic injection with articaine 4% 1:100,000 epinephrine

Locations
Country Name City State
Egypt Omar Ahmed Al Minya

Sponsors (1)
Lead Sponsor Collaborator
Minia University

Country where clinical trial is conducted

Egypt, 

Outcome
Type Measure Description Time frame Safety issue
Primary Pain assessment Wong Backer pain scale up to 24 hours
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