Potassium Nitrate in Polycarboxylate as a Direct Pulp Capping

Sponsor

Minia University (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT05912907

Collaborator

(none)

126

Enrollment

Location

Arms

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

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

Condition or Disease	Intervention/Treatment	Phase
Pulp Disease, Dental	Other: potassium nitrate in polycarboxilate cement	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

126 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

Potassium Nitrate in Polycarboxylate Versus Mineral Trioxide Aggregate as a Direct Pulp Capping in Young Permanent Molars

Actual Study Start Date :

Jun 1, 2022

Anticipated Primary Completion Date :

Jul 1, 2024

Anticipated Study Completion Date :

Jul 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: potassium nitrate in polycarboxilate cement	Other: potassium nitrate in polycarboxilate cement 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
Active Comparator: Mineral Trioxide Aggregate	Other: potassium nitrate in polycarboxilate cement 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

Arm

Intervention/Treatment

Experimental: potassium nitrate in polycarboxilate cement

Other: potassium nitrate in polycarboxilate cement

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

Active Comparator: Mineral Trioxide Aggregate

Other: potassium nitrate in polycarboxilate cement

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

Outcome Measures

Primary Outcome Measures

clinical success rate [24 months]
Absence of pain, sensitivity to percussion, fistula or sinus tract, mobility
Radiographic success rate [24 months]
Absence of periapical radiolucency, internal root resorption, external root resorption

Eligibility Criteria

Criteria

Ages Eligible for Study:

6 Years to 10 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Minia University	Al 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:

NCT05912907

Other Study ID Numbers:

First Posted:

Jun 22, 2023

Last Update Posted:

Jun 22, 2023

Last Verified:

Jun 1, 2023

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Dental Pulp Diseases

Stomatognathic Diseases

Study Results

No Results Posted as of Jun 22, 2023