NCT06170775

Brief Summary

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

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Dec 2023

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

First Submitted

Initial submission to the registry

December 6, 2023

Completed
8 days until next milestone

First Posted

Study publicly available on registry

December 14, 2023

Completed
6 days until next milestone

Study Start

First participant enrolled

December 20, 2023

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 20, 2024

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 20, 2025

Completed
Last Updated

December 14, 2023

Status Verified

December 1, 2023

Enrollment Period

1 year

First QC Date

December 6, 2023

Last Update Submit

December 13, 2023

Conditions

Pulp Disease, Dental

Outcome Measures

Primary Outcomes (2)

  • Clinical success

    Absence of pain, swelling and sinus tract

    One year

  • Radiographic success

    Absence of periapical lesions, internal or external root resorption

    One year

Study Arms (2)

Sodiumhexametaphosphate

EXPERIMENTAL
Other: Pulp therapyDrug: Sodiumhexametaphosphate

MTA

ACTIVE COMPARATOR
Other: Pulp therapyOther: MTA

Interventions

Pulp therapyOTHER

Pulp capping material

MTASodiumhexametaphosphate
SodiumhexametaphosphateDRUG

Sodiumhexametaphosphate

Sodiumhexametaphosphate
MTAOTHER

MTA

MTA

Eligibility Criteria

Age4 Years - 10 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • physical healthy children
  • cooperative children
  • primary molar with deep carious lesion
  • absence of pain or transient momentary pain

You may not qualify if:

  • Uncooperative children
  • children with systemic disorders
  • periapical lesions
  • sever pain

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Dental Pulp Diseases

Interventions

Pemetrexed

Condition Hierarchy (Ancestors)

Tooth DiseasesStomatognathic Diseases

Intervention Hierarchy (Ancestors)

GuanineHypoxanthinesPurinonesPurinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsGlutamatesAmino Acids, AcidicAmino AcidsAmino Acids, Peptides, and ProteinsAmino Acids, Dicarboxylic

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
Lecturer

Study Record Dates

First Submitted

December 6, 2023

First Posted

December 14, 2023

Study Start

December 20, 2023

Primary Completion

December 20, 2024

Study Completion

January 20, 2025

Last Updated

December 14, 2023

Record last verified: 2023-12