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

NCT05441995 | Unknown

• 1 other identifier: 630
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 1

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.

Conditions

Cryotherapy Effect; Irreversible Pulpitis; Pain

Outcome Measures

Primary Outcomes (1)

• Pain intensity

  Pain was assessed using Visual Analogue Scale (VAS)

  up to 24 hours

Study Arms (2)

Cryotherapy

EXPERIMENTAL

Other: Cryotherapy

Inferior alveolar nerve block

ACTIVE COMPARATOR

Other: Cryotherapy

Interventions

Cryotherapy OTHER

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

Cryotherapy; Inferior alveolar nerve block

Eligibility Criteria

• Age: 9 Years - 17 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Minia University: lead

Study Sites (1)

Minia University

Minya, Minya Governorate, 61111, Egypt

Location

MeSH Terms

Conditions

Pain

Interventions

Cryotherapy

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Therapeutics

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: June 28, 2022
• First Posted: July 1, 2022
• Study Start: June 1, 2022
• Primary Completion: August 1, 2022
• Study Completion: August 1, 2022
• Last Updated: July 1, 2022

Record last verified: 2022-06

Locations

EG (1)