NCT05314842

Brief Summary

examine the results of pulpotomy in primary molars using premixed bioceramic MTA versus Formocresol. Clinical and radiographic success rates were used as outcomes.

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
40

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Apr 2022

Shorter than P25 for phase_3

Status
unknown

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 25, 2022

Completed
7 days until next milestone

Study Start

First participant enrolled

April 1, 2022

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 6, 2022

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2023

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2023

Completed
Last Updated

April 6, 2022

Status Verified

March 1, 2022

Enrollment Period

1 year

First QC Date

March 25, 2022

Last Update Submit

April 2, 2022

Conditions

Caries

Outcome Measures

Primary Outcomes (4)

  • Soft-tissue pathology

    * Post-treatment swelling will be assessed through visual examination by the operator, either intraorally or extra orally. * Sinus tract or fistula will be assessed through visual examination by the operator. Binary (present or absent)

    at 0 day

  • Soft-tissue pathology

    * Post-treatment swelling will be assessed through visual examination by the operator, either intraorally or extra orally. * Sinus tract or fistula will be assessed through visual examination by the operator. Binary (present or absent)

    at 3 month

  • Soft-tissue pathology

    * Post-treatment swelling will be assessed through visual examination by the operator, either intraorally or extra orally. * Sinus tract or fistula will be assessed through visual examination by the operator. Binary (present or absent)

    at 6 month

  • Soft-tissue pathology

    Post-treatment swelling will be assessed through visual examination by the operator, either intraorally or extra orally. -Sinus tract or fistula will be assessed through visual examination by the operator. Binary (present or absent)

    at 1 year

Secondary Outcomes (12)

  • • Pain to the percussion

    at 0 day

  • • Pain to the percussion

    at 3 month

  • • Pain to the percussion

    at 6 month

  • • Pain to the percussion

    at 1 year

  • mobility

    at 0 day

  • +7 more secondary outcomes

Study Arms (2)

control group

ACTIVE COMPARATOR

the group that have caries in primary molars and treat them with formocresol

Drug: Formocresol

experimental group

EXPERIMENTAL

the group that have caries in primary molars and treat them with premixed bioceramic MTA

Drug: Premixed bioceramic MTA

Interventions

FormocresolDRUG

dressing agents in pulpotomized primary molas using formocresol in cariously exposed vital primary molars

control group
Premixed bioceramic MTADRUG

dressing agents in pulpotomized primary molas using premixed bioceramic MTA in cariously exposed vital primary molars

Also known as: Neoputty
experimental group

Eligibility Criteria

Age4 Years - 6 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Medically fit and cooperative children.
  • Pediatric patients aged 4-6 years.
  • A deep carious lesion in vital primary molars.
  • Absence of clinical signs and symptoms of pulpal exposure.
  • Absence of radiographic signs and symptoms of people degeneration.
  • Positive parental informed consent.

You may not qualify if:

  • Uncooperative children.
  • Medically compromised children.
  • Presence of clinical signs and symptoms of pulpal exposure.
  • Presence of radiographic signs and symptoms of pulp degeneration.
  • Physiologic root resorption more than one-third.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Interventions

formocresol

Study Officials

  • ahmed m Elkhadem, Ass.Prof

    Cairo University

    STUDY CHAIR

Central Study Contacts

sarah A Mahmoud, B.D.S

CONTACT

01023469565sarah_mahmoud@dentistry.cu.edu.eg

maiI A Mahmed, PHD

CONTACT

01012632608mai.ali@dentistry.cu.edu.eg

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
principal investigator

Study Record Dates

First Submitted

March 25, 2022

First Posted

April 6, 2022

Study Start

April 1, 2022

Primary Completion

April 1, 2023

Study Completion

May 1, 2023

Last Updated

April 6, 2022

Record last verified: 2022-03

Data Sharing

IPD Sharing
Will not share