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

Sponsor
Minia University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05441995
Collaborator
(none)
140
Enrollment
1
Location
2
Arms
2
Anticipated Duration (Months)
69.9
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Cryotherapy
 N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
140 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Outcomes Assessor)
Primary Purpose:
Other
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
Anticipated Study Start Date :
Jun 1, 2022
Anticipated Primary Completion Date :
Aug 1, 2022
Anticipated Study Completion Date :
Aug 1, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: Cryotherapy

Other: Cryotherapy
Ice packs were applied in the buccal mucosa related to the tooth for 5 minutes after IANB administration
Active Comparator: Inferior alveolar nerve block

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

Outcome Measures

Primary Outcome Measures

  1. Pain intensity [up to 24 hours]

    Pain was assessed using Visual Analogue Scale (VAS)

Eligibility Criteria

Criteria

Ages Eligible for Study:
9 Years to 17 Years
Sexes Eligible for Study:
All
Accepts 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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Minia University Minya El Minya Egypt 61111

Sponsors and Collaborators

  • Minia University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Ahmad Elheeny, Assistant Professor, Minia University
ClinicalTrials.gov Identifier:
NCT05441995
Other Study ID Numbers:
  • 630
First Posted:
Jul 1, 2022
Last Update Posted:
Jul 1, 2022
Last Verified:
Jun 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Pulpitis

Study Results

No Results Posted as of Jul 1, 2022