Pulp Response to Castor OilNCT05723900
Evaluation of Pulp Response to Castor Oil
A study testing Castor oil and Formocresol in people with Pulp Response to Castor Oil, run by Tanta University at 1 site in Egypt.
Trial summary
The present study was conducted to evaluate and compare pulp response to Castor oil versus Formocresol as Pulpotomy Medicaments in Primary Teeth Read more about this study
- Who is it for?
- Ages 7 to 9 yearsHealthy volunteers can take part
- Conditions the study is for
- Pulp Response to Castor Oil
- What is being tested?
- Castor oil and Formocresol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Sep 2022to 15 Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 7 to 9 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- healthy cooperative children with sound primary canines indicated for extraction for orthodontic reasons
Who cannot join
- caries primary canines Presence of systemic pathology
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
- Conditions
- Pulp Response to Castor Oil
- Being tested
- Castor oil, Formocresol
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Castor oilDrug
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
FormocresolDrug
Group II treated with formocresol
| Study group | Role | What they receive |
|---|---|---|
| Castor oil | Experimental | Castor oil applied to one side of the selected primary canine Receives: Drug: Castor oil |
| Formocresol | Experimental | Formocresol applied to other side Receives: Drug: Formocresol |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 2 weeks to 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2023
- Study start15 Sep 2022
- Primary completion1 Oct 2022
- Study completion15 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulp Response to Castor OilStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tanta University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shimaa Hadwa, Tanta University
- Investigators
- shomaa Mostafa Hadwa, PHD, Principal investigator, Tanta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05723900
- Sponsor's protocol ID
- #R-PED-10-22-6,
- Status last verified
- Oct 2022
- First submitted
- 22 Jan 2023
- Last updated
- 13 Feb 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Evaluation of Pulp Response to Castor Oil Versus Formocresol as Pulpotomy Medicaments in Primary Teeth :An in Vivo Study
- ClinicalTrials.gov ID
- NCT05723900
- Acronym / sponsor ID
- #R-PED-10-22-6,
- Conditions
- Pulp Response to Castor Oil
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- Tanta UniversityUniversity, hospital or other
- Study start
- 15 Sep 2022 (actual)
- Primary completion
- 1 Oct 2022 (actual)
- Study completion
- 15 Dec 2022 (actual)
- First posted
- 13 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The present study was conducted to evaluate and compare pulp response to Castor oil versus Formocresol as Pulpotomy Medicaments in Primary Teeth
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Castor oil | Experimental | Drug: Castor oilCastor oil applied to one side of the selected primary canine |
| Formocresol | Experimental | Drug: FormocresolFormocresol applied to other side |
Who may qualify
- Ages
- 7 to 9 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- healthy cooperative children with sound primary canines indicated for extraction for orthodontic reasons
Key exclusion criteria (1 listed)
- caries primary canines Presence of systemic pathology
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Castor oilProcedure :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 | Drug | Castor oil |
| FormocresolGroup II treated with formocresol | Drug | Formocresol |
Primary outcome
The degree of pulp inflammation using score.
Time frame: 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
The presence or absence of dentin chips formation by using scores 0 or 1.
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2023.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
shomaa Mostafa Hadwa, PHD principal investigator
Tanta University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Castor oil and Formocresol in people with Pulp Response to Castor Oil, run by Tanta University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The degree of pulp inflammation using score. (time frame: 2 weeks to 3 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Feb 2023.