Back to resultsCryotherapy Efficacy During Pulp Therapy of the Mandibular First Permanent Molars in Children
Primary Purpose
Cryotherapy Effect, Irreversible Pulpitis, Pain
Status
Not yet recruiting
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Cryotherapy
Sponsored by
About this trial
This is an interventional other trial for Cryotherapy Effect
Eligibility Criteria
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.
Sites / Locations
- Minia University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Cryotherapy
Inferior alveolar nerve block
Arm Description
Outcomes
Primary Outcome Measures
Pain intensity
Pain was assessed using Visual Analogue Scale (VAS)
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05441995
Brief Title
Cryotherapy Efficacy During Pulp Therapy of the Mandibular First Permanent Molars in Children
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
Study Type
Interventional
2. Study Status
Record Verification Date
June 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
June 2022 (Anticipated)
Primary Completion Date
August 2022 (Anticipated)
Study Completion Date
August 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Minia University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cryotherapy Effect, Irreversible Pulpitis, Pain
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
140 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Cryotherapy
Arm Type
Experimental
Arm Title
Inferior alveolar nerve block
Arm Type
Active Comparator
Intervention Type
Other
Intervention Name(s)
Cryotherapy
Intervention Description
Ice packs were applied in the buccal mucosa related to the tooth for 5 minutes after IANB administration
Primary Outcome Measure Information:
Title
Pain intensity
Description
Pain was assessed using Visual Analogue Scale (VAS)
Time Frame
up to 24 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
9 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Facility Information:
Facility Name
Minia University
City
Minya
State/Province
El Minya
ZIP/Postal Code
61111
Country
Egypt
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Omar Ahmed
Phone
0020862347768
Email
EG135.30708112400351@nies-edu.org
12. IPD Sharing Statement
Learn more about this trial
Cryotherapy Efficacy During Pulp Therapy of the Mandibular First Permanent Molars in Children
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