Cryotherapy Efficacy During Pulp Therapy of the Mandibular First Permanent Molars in Children

Not Applicable

• Conditions: Pain; Irreversible Pulpitis; Cryotherapy Effect
• Interventions: Other: Cryotherapy

• Registration Number: NCT05441995
• Lead Sponsor: Minia University

Brief Summary

The aim of the study is to assess the efficacy of cryotherapy application on the success of inferior alveolar nerve block (IANB) in reducing pain during pulp therapy of the mandibular first permanent molars with irreversible pulpitis (IP) in children age from 7 to 16 years. The null hypothesis (H0) supposed no difference in pain intensity during pulp therapy of primary molars with IP anesthetized with IANB with and without cryotherapy application. The secondary aim was to evaluate the children's behavior before and after pulpectomy in the two groups.

Detailed Description

Not available

Study Timeline

• Status Verified: 2022-06
• Study Start: 2022-06
• Study First Submitted: 2022-06-28
• Study First Submitted QC: 2022-06-28
• Last Update Submitted: 2022-06-28
• Study First Posted: 2022-07-01
• Last Update Posted: 2022-07-01
• Primary Completion: 2022-08
• Study Completion: 2022-08

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 140

Inclusion Criteria

• Healthy children aged 9-17 years who were categorized as class I or II according to the ASA classification.
• Cooperative children (rate 3 or 4 according to Frankl behavior rating scale)
• Presence of a vital mandibular first permanent molar with SIP, the tooth should show deep caries or dental restorations with a history of spontaneous lingered pain precipitated by thermal stimuli. To confirm the diagnosis of irreversible pulpitis, early response to electric pulp and thermal testing was performed.
• No radiographic changes with at least two-thirds of the root must be evident.

Exclusion Criteria

• Children with severe emotional, intellectual, and behavioral difficulties.
• Necrotic pulp of primary molars.
• Unrestorable crowns
• Positive history of gingival swelling, abnormal mobility, and fistulous tract.
• Presence of radiographic signs of periapical and/or furcation radiolucency, and pathological resorption.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Cryotherapy	Cryotherapy	-
Inferior alveolar nerve block	Cryotherapy	-

Primary Outcome Measures

Name	Time	Method
Pain intensity	up to 24 hours	Pain was assessed using Visual Analogue Scale (VAS)

Trial Locations

Locations (1)

Minia University; 🇪🇬 Minya, El Minya, Egypt