NCT05723900

Brief Summary

The present study was conducted to evaluate and compare pulp response to Castor oil versus Formocresol as Pulpotomy Medicaments in Primary Teeth

Trial Health

87
On Track

Trial Health Score

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

Enrollment
31

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2022

Shorter than P25 for not_applicable

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 15, 2022

Completed
16 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2022

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 15, 2022

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

January 22, 2023

Completed
22 days until next milestone

First Posted

Study publicly available on registry

February 13, 2023

Completed
Last Updated

February 13, 2023

Status Verified

October 1, 2022

Enrollment Period

16 days

First QC Date

January 22, 2023

Last Update Submit

February 10, 2023

Conditions

Outcome Measures

Primary Outcomes (2)

  • The degree of pulp inflammation using score.

    The degree of pulp inflammation using scores from 0 to 5 , 0 mean no inflammation ,5 mean abscess formation . Measurement the effect of the castor oil as pulp medicament in treated teeth which subjected to decalcification procedure for histological evaluation under light microscope

    2 weeks to 3 months

  • The presence or absence of dentin chips formation by using scores 0 or 1.

    The presence or absence of dentin chips formation by using scores 0 or 1. Measurement the effect of the castor oil as pulp medicament in treated teeth which subjected to decalcification procedure for histological evaluation under light microscope

    2 weeks to 3 months

Study Arms (2)

Castor oil

EXPERIMENTAL

Castor oil applied to one side of the selected primary canine

Drug: Castor oil

Formocresol

EXPERIMENTAL

Formocresol applied to other side

Drug: Formocresol

Interventions

Procedure :pulpotomy procedure and histological evaluation. A sample of sixty two primary teeth from thirty healthy cooperative children of both sexes who were between 7-9 years and referred to Pediatric Dentistry Department. Two sound teeth without pulpotomy procedure were extracted and subjected to histological procedures to examine the normal pulp tissue and tissue organization (Negative control). The pulpotomy procedure was performed in sixty primary teeth (by split mouth design). group I treated with castor oil

Castor oil

Group II treated with formocresol

Formocresol

Eligibility Criteria

Age7 Years - 9 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • healthy cooperative children with sound primary canines indicated for extraction for orthodontic reasons

You may not qualify if:

  • caries primary canines Presence of systemic pathology

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of dentistry

Tanta, Egypt

Location

MeSH Terms

Interventions

Castor Oilformocresol

Intervention Hierarchy (Ancestors)

Fats, UnsaturatedFatsLipidsPlant OilsOilsPlant PreparationsBiological ProductsComplex Mixtures

Study Officials

  • shomaa Mostafa Hadwa, PHD

    Tanta University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer in pediatric dentistry department faculty of dentistry tanta university

Study Record Dates

First Submitted

January 22, 2023

First Posted

February 13, 2023

Study Start

September 15, 2022

Primary Completion

October 1, 2022

Study Completion

December 15, 2022

Last Updated

February 13, 2023

Record last verified: 2022-10

Locations