Evaluation of Pulp Response to Castor Oil

Comparative Evaluation of Pulp Response to Castor Oil Versus Formocresol as Pulpotomy Medicaments in Primary Teeth :An in Vivo Study

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

Study Overview

• Status: Completed
• Conditions: Pulp Response to Castor Oil
• Intervention / Treatment: Drug: Castor oil; Drug: Formocresol

• Study Type: Interventional
• Enrollment (Actual): 31
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Tanta, Egypt
    • Faculty of Dentistry

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 7 years to 9 years (CHILD)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

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

Exclusion Criteria:

• caries primary canines Presence of systemic pathology

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Castor oil; Castor oil applied to one side of the selected primary canine	Drug: Castor oil; 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
EXPERIMENTAL: Formocresol; Formocresol applied to other side	Drug: Formocresol; Group II treated with formocresol

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Tanta University
• Investigators: Principal Investigator: shomaa Mostafa Hadwa, PHD, Tanta University

Study record dates

Study Major Dates

• Study Start (ACTUAL): September 15, 2022
• Primary Completion (ACTUAL): October 1, 2022
• Study Completion (ACTUAL): December 15, 2022

Study Registration Dates

• First Submitted: January 22, 2023
• First Submitted That Met QC Criteria: February 10, 2023
• First Posted (ACTUAL): February 13, 2023

Study Record Updates

• Last Update Posted (ACTUAL): February 13, 2023
• Last Update Submitted That Met QC Criteria: February 10, 2023
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Gastrointestinal Agents; Cathartics; Castor Oil
• Other Study ID Numbers: #R-PED-10-22-6,

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No