NCT05020223

Brief Summary

450 healthy children with primary teeth of deep carious lesions without signs or symptomes of irreverisible pulp damage was selected randompy divoded into 3 groups each of 150 children that inder go vital pulp therapy through pulpotomy,direct pulp capping or indirect pulp capping using MTA as capping material for each modality then followed up for 2 years or more

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
450

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2020

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

August 1, 2020

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

August 15, 2021

Completed
10 days until next milestone

First Posted

Study publicly available on registry

August 25, 2021

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2023

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2023

Completed
Last Updated

August 25, 2021

Status Verified

August 1, 2021

Enrollment Period

3 years

First QC Date

August 15, 2021

Last Update Submit

August 18, 2021

Conditions

Deep Caries

Outcome Measures

Primary Outcomes (5)

  • Tenderness

    Precence or abscence

    2 years

  • Abcess

    Precence or abscence

    2 years

  • Fistula

    Precence or abscence

    2 years

  • lamina dura

    Intact or distorted

    2 years

  • Periapical radiographic radiolucency

    Precence or abcencs

    2 years

Study Arms (3)

MTA pulpotomy

EXPERIMENTAL

Usuing MTA as capping material for cervical pulpotomy as a treatment option for deep carious primary teeth with signs and symptoms of reversible pulpitis in presence of pulp exposure

Other: Vital pulp therapy

MTA direct pulp capping

EXPERIMENTAL

Using MTA as capping material in case of trearment of deep carious primary teeth with signs and symptoms of reversible pulpitis with presence of pulp exposure

Other: Vital pulp therapy

MTA indirect pulp capping

EXPERIMENTAL

Using MTA as indirect capping material for treatment of deep carious primary teeth with signs and symptoms of reversible pulpitis

Other: Vital pulp therapy

Interventions

Vital pulp therapyOTHER

Vital pulp therapy different modalities for management of deep carious lesion in primary teeth

MTA direct pulp cappingMTA indirect pulp cappingMTA pulpotomy

Eligibility Criteria

Age3 Years - 10 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Healthy children
  • Aged from 3 to 10 years old
  • Deep cariuos primary tooth

You may not qualify if:

  • Primary teeth with any signs or syptoms of irreversible pulpitis
  • Primary teeth of any signs or symptomes of vitality loss
  • Primary teeth near to exfoliation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Minia University

Minya, 61111, Egypt

RECRUITING

Central Study Contacts

Mahmoud A Mahmoud

CONTACT

01009578837Mam.dent@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer

Study Record Dates

First Submitted

August 15, 2021

First Posted

August 25, 2021

Study Start

August 1, 2020

Primary Completion

August 1, 2023

Study Completion

September 1, 2023

Last Updated

August 25, 2021

Record last verified: 2021-08

Locations

EG(1)