Back to resultsPotassium Nitrate in Polycarboxylate as a Direct Pulp Capping
Primary Purpose
Pulp Disease, Dental
Status
Active
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
potassium nitrate in polycarboxilate cement
Sponsored by
About this trial
This is an interventional treatment trial for Pulp Disease, Dental
Eligibility Criteria
Inclusion Criteria: 7-10 years of children Healthy children classified as ASA I or II Asymptomatic vital immature mandibular first molar with extensive and deep caries Signs and symptoms of reversible pulpitis Exclusion Criteria: Necrotic teeth or teeth with irreversible pulpitis Medically compromised children
Sites / Locations
- Minia University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
potassium nitrate in polycarboxilate cement
Mineral Trioxide Aggregate
Arm Description
Outcomes
Primary Outcome Measures
clinical success rate
Absence of pain, sensitivity to percussion, fistula or sinus tract, mobility
Radiographic success rate
Absence of periapical radiolucency, internal root resorption, external root resorption
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05912907
Brief Title
Potassium Nitrate in Polycarboxylate as a Direct Pulp Capping
Official Title
Potassium Nitrate in Polycarboxylate Versus Mineral Trioxide Aggregate as a Direct Pulp Capping in Young Permanent Molars
Study Type
Interventional
2. Study Status
Record Verification Date
June 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
June 1, 2022 (Actual)
Primary Completion Date
July 2024 (Anticipated)
Study Completion Date
July 2024 (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
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The study aimed to compare potassium nitrate in polycarboxylate cement to mineral trioxide aggregate as a direct pulp capping material of young permanent teeth in patients from 7 to 10 ears
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pulp Disease, Dental
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
126 (Actual)
8. Arms, Groups, and Interventions
Arm Title
potassium nitrate in polycarboxilate cement
Arm Type
Experimental
Arm Title
Mineral Trioxide Aggregate
Arm Type
Active Comparator
Intervention Type
Other
Intervention Name(s)
potassium nitrate in polycarboxilate cement
Intervention Description
5% potassium nitrate in polycarboxylate; pre-weighed 95 mg zinc oxide powder and 5mg of KNO3 will be placed on a glass slab followed by mixing by polyacrylic acid (liquid) in a 1:1 P/L ratio
Primary Outcome Measure Information:
Title
clinical success rate
Description
Absence of pain, sensitivity to percussion, fistula or sinus tract, mobility
Time Frame
24 months
Title
Radiographic success rate
Description
Absence of periapical radiolucency, internal root resorption, external root resorption
Time Frame
24 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
10 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
7-10 years of children
Healthy children classified as ASA I or II
Asymptomatic vital immature mandibular first molar with extensive and deep caries
Signs and symptoms of reversible pulpitis
Exclusion Criteria:
Necrotic teeth or teeth with irreversible pulpitis
Medically compromised children
Facility Information:
Facility Name
Minia University
City
Al Minya
ZIP/Postal Code
61111
Country
Egypt
12. IPD Sharing Statement
Learn more about this trial
Potassium Nitrate in Polycarboxylate as a Direct Pulp Capping
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