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

Pain Clinical Trial

Official title:

Cryotherapy Efficacy in 9 to17-year-old Children During Endodontic Treatment of the Mandibular First Permanent Molars With Symptomatic Irreversible Pulpitis: a Randomized Parallel Controlled Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05441995
• Other study ID #: 630
• Status: Not yet recruiting
• Phase: N/A
• Start date: June 2022
• Est. completion date: August 2022

Study information

• Verified date: June 2022
• Source: Minia University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 140
• Est. completion date: August 2022
• Est. primary completion date: August 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 9 Years to 17 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cryotherapy Effect
• Irreversible Pulpitis
• Pain
• Pulpitis

Intervention

Other:
• Cryotherapy
Ice packs were applied in the buccal mucosa related to the tooth for 5 minutes after IANB administration

Locations

Country	Name	City	State
Egypt	Minia University	Minya	El 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 intensity	Pain was assessed using Visual Analogue Scale (VAS)	up to 24 hours