- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06170775
Sodiumhexametaphosphate as Pulp Capping Material for Primary Teeth
December 13, 2023 updated by: Mahmoud Ahmed Mahmoud, Minia University
Sodiumhexametaphosphate Versus MTA as Pulp Capping Material for Primary Teeth ( Randomized Clinical Trial)
Sodiumhexametaphosphate will be tested as pulp capping material in comparison to MTA for primary teeth pulp therapy
Study Overview
Status
Not yet recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Estimated)
100
Phase
- Not Applicable
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- physical healthy children
- cooperative children
- primary molar with deep carious lesion
- absence of pain or transient momentary pain
Exclusion Criteria:
- Uncooperative children
- children with systemic disorders
- periapical lesions
- sever pain
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: MTA
|
Pulp capping material
MTA
|
|
Experimental: Sodiumhexametaphosphate
|
Pulp capping material
Sodiumhexametaphosphate
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Clinical success
Time Frame: One year
|
Absence of pain, swelling and sinus tract
|
One year
|
|
Radiographic success
Time Frame: One year
|
Absence of periapical lesions, internal or external root resorption
|
One year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Estimated)
December 20, 2023
Primary Completion (Estimated)
December 20, 2024
Study Completion (Estimated)
January 20, 2025
Study Registration Dates
First Submitted
December 6, 2023
First Submitted That Met QC Criteria
December 13, 2023
First Posted (Estimated)
December 14, 2023
Study Record Updates
Last Update Posted (Estimated)
December 14, 2023
Last Update Submitted That Met QC Criteria
December 13, 2023
Last Verified
December 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1290
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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