NCT05912907

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
126

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2022

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2022

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

June 11, 2023

Completed
11 days until next milestone

First Posted

Study publicly available on registry

June 22, 2023

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2024

Completed
Last Updated

June 22, 2023

Status Verified

June 1, 2023

Enrollment Period

2.1 years

First QC Date

June 11, 2023

Last Update Submit

June 11, 2023

Conditions

Pulp Disease, Dental

Outcome Measures

Primary Outcomes (2)

  • clinical success rate

    Absence of pain, sensitivity to percussion, fistula or sinus tract, mobility

    24 months

  • Radiographic success rate

    Absence of periapical radiolucency, internal root resorption, external root resorption

    24 months

Study Arms (2)

potassium nitrate in polycarboxilate cement

EXPERIMENTAL
Other: potassium nitrate in polycarboxilate cement

Mineral Trioxide Aggregate

ACTIVE COMPARATOR
Other: potassium nitrate in polycarboxilate cement

Interventions

potassium nitrate in polycarboxilate cementOTHER

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

Mineral Trioxide Aggregatepotassium nitrate in polycarboxilate cement

Eligibility Criteria

Age6 Years - 10 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • Necrotic teeth or teeth with irreversible pulpitis
  • Medically compromised children

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Minia University

Al Minyā, 61111, Egypt

Location

MeSH Terms

Conditions

Dental Pulp Diseases

Interventions

potassium nitrate

Condition Hierarchy (Ancestors)

Tooth DiseasesStomatognathic Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

June 11, 2023

First Posted

June 22, 2023

Study Start

June 1, 2022

Primary Completion

July 1, 2024

Study Completion

July 1, 2024

Last Updated

June 22, 2023

Record last verified: 2023-06

Locations

EG(1)