NCT04397094

Brief Summary

Light cured silicate based cement (theracal LC) pulpotomy was compared to formocresol pulpotomy in primary molars.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Dec 2017

Geographic Reach
1 country

1 active site

Status
completed

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

December 1, 2017

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 17, 2018

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

March 30, 2019

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

May 17, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 21, 2020

Completed
2 months until next milestone

Results Posted

Study results publicly available

July 29, 2020

Completed
Last Updated

July 29, 2020

Status Verified

July 1, 2020

Enrollment Period

4 months

First QC Date

May 17, 2020

Results QC Date

June 21, 2020

Last Update Submit

July 11, 2020

Conditions

Deep Caries

Keywords

Theracalformocresolpulpotomy

Outcome Measures

Primary Outcomes (1)

  • Clinical Examination

    Number of participants with tooth mobility, restoration loss, gingival swelling/fistula, pain on percussion.

    12 months

Secondary Outcomes (1)

  • Radiographic Examination

    12 months

Study Arms (2)

Theracal LC

EXPERIMENTAL

Theracal LC was used as a medicament to cover root stumps of asymptomatic thirty primary molars with vital pulp exposures. Teeth were followed up clinically and radiographically for 12 months.

Drug: Theracal LC

Formocresol

ACTIVE COMPARATOR

Formocresol was used as a medicament to cover root stumps of asymptomatic thirty primary molars with vital pulp exposures. Teeth were followed up clinically and radiographically for 12 months.

Drug: Formocresol

Interventions

Theracal LCDRUG

pulpotomy

Theracal LC
FormocresolDRUG

Pulpotomy

Formocresol

Eligibility Criteria

Age4 Years - 7 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • healthy, cooperative children
  • mandibular primary molars with vital pulp exposures

You may not qualify if:

  • clinical or radiographic evidence of irreversible pulpitis
  • physiological root resorption

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Dentistry, Ain Shams University

Cairo, 1156, Egypt

Location

MeSH Terms

Interventions

formocresol

Results Point of Contact

Title
Dr. Mariem Wassel
Organization
Faculty of Dentistry Ain Shams University
mariem.wassel@dent.asu.edu.eg
+2 0064871416

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant professor

Study Record Dates

First Submitted

May 17, 2020

First Posted

May 21, 2020

Study Start

December 1, 2017

Primary Completion

March 17, 2018

Study Completion

March 30, 2019

Last Updated

July 29, 2020

Results First Posted

July 29, 2020

Record last verified: 2020-07

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)