Sodiumhexametaphosphate as Pulp Capping Material for Prim... | NCT06170775

Studies
Sodiumhexametaphosphate as Pulp Capping Material for Primary Teeth

NCT06170775

Sponsor

Minia University

Status

Unknown status

Last Update Posted

Dec 14, 2023Actual

Enrollment

100Estimated

Phase

Not Applicable

Conditions

Pulp Disease, Dental

Interventions

Pulp therapy
Sodiumhexametaphosphate
MTA

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2023

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 20, 2023Estimated

Primary Completion Date

Dec 20, 2024Estimated

Completion Date

Jan 20, 2025Estimated

First Submitted Date

Dec 6, 2023

First Submission Date that Met QC Criteria

Dec 13, 2023

First Posted Date

Dec 14, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 13, 2023

Last Update Posted Date

Dec 14, 2023Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Sodiumhexametaphosphate will be tested as pulp capping material in comparison to MTA for primary teeth pulp therapy

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

100Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Sodiumhexametaphosphate	Experimental		Other: Pulp therapy Drug: Sodiumhexametaphosphate
MTA	Active Comparator		Other: Pulp therapy Other: MTA

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Pulp therapy	Other	Pulp capping material	MTA Sodiumhexametaphosphate

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Clinical success	Absence of pain, swelling and sinus tract	One year
Radiographic success	Absence of periapical lesions, internal or external root resorption	One year

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

4 Years

Maximum Age

10 Years

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D003788	Dental Pulp Diseases

Ancestor Terms

ID	Term
D014076	Tooth Diseases
D009057	Stomatognathic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000068437	Pemetrexed

Ancestor Terms

ID	Term
D006147	Guanine
D007042	Hypoxanthines
D011688	Purinones
D011687	Purines
D006574

Browse Leaves

Not provided

Browse Branches

Not provided