The Success Rate of Cryotherapy Application in Primary Molars With Signs of Irreversible Pulpitis
1 other identifier
interventional
188
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Feb 2022
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 22, 2022
CompletedStudy Start
First participant enrolled
February 22, 2022
CompletedFirst Posted
Study publicly available on registry
March 4, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 30, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
April 30, 2022
CompletedMarch 4, 2022
March 1, 2022
2 months
February 22, 2022
March 2, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
Pain assessment
Wong Backer pain scale
up to 24 hours
Study Arms (2)
Cryotherapy during inferior alveolar nerve block
EXPERIMENTALInferior alveolar nerve block
ACTIVE COMPARATORInterventions
local anesthetic injection with articaine 4% 1:100,000 epinephrine then an application ice packs
local anesthetic injection with articaine 4% 1:100,000 epinephrine
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Minia Universitylead
Study Sites (1)
Omar Ahmed
Al Minyā, 61111, Egypt
Related Publications (1)
Elheeny AAH, Sermani DI, Saliab EA, Turky M. Cryotherapy and pain intensity during endodontic treatment of mandibular first permanent molars with symptomatic irreversible pulpitis: A randomized controlled trial. Clin Oral Investig. 2023 Aug;27(8):4585-4593. doi: 10.1007/s00784-023-05084-1. Epub 2023 Jun 3.
PMID: 37268843DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor
Study Record Dates
First Submitted
February 22, 2022
First Posted
March 4, 2022
Study Start
February 22, 2022
Primary Completion
April 30, 2022
Study Completion
April 30, 2022
Last Updated
March 4, 2022
Record last verified: 2022-03