Evaluation of Pulp Response to Castor Oil

• Sponsor: Tanta University (Other)
• Overall Status: Completed
• CT.gov ID: NCT05723900
• Collaborator: (none)
• Enrollment: 31
• Location: 1
• Arms: 2
• Actual Duration (Months): 3
• Patients Per Site Per Month: 10.4

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Pulp Response to Castor Oil	Drug: Castor oil; Drug: Formocresol	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 31 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Comparative Evaluation of Pulp Response to Castor Oil Versus Formocresol as Pulpotomy Medicaments in Primary Teeth :An in Vivo Study
• Actual Study Start Date: Sep 15, 2022
• Actual Primary Completion Date: Oct 1, 2022
• Actual Study Completion Date: Dec 15, 2022

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. The degree of pulp inflammation using score. [2 weeks to 3 months]

   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. The presence or absence of dentin chips formation by using scores 0 or 1. [2 weeks to 3 months]

   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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 7 Years to 9 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

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

Exclusion Criteria:

• caries primary canines Presence of systemic pathology

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Faculty of dentistry	Tanta		Egypt

Sponsors and Collaborators

• Tanta University

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Shimaa Hadwa, Lecturer in pediatric dentistry department faculty of dentistry tanta university, Tanta University
• ClinicalTrials.gov Identifier: NCT05723900
• Other Study ID Numbers: #R-PED-10-22-6,
• First Posted: Feb 13, 2023
• Last Update Posted: Feb 13, 2023
• Last Verified: Oct 1, 2022

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Castor Oil

Study Results

No Results Posted as of Feb 13, 2023