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

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

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05441995

Enrollment

140

Registered

2022-07-01

Start date

2022-06-30

Completion date

2022-08-31

Last updated

2022-07-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cryotherapy Effect, Irreversible Pulpitis, Pain

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.

Interventions

OTHERCryotherapy

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

OTHER

Masking

SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

9 Years to 17 Years

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	Time frame	Description
Pain intensity	up to 24 hours	Pain was assessed using Visual Analogue Scale (VAS)

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026