Non-Vital ToothPhase 1/2NCT05801367
Allium Sativum Oil as Alternative Non-vital Pulpotomy Medicament in Primary Teeth
A Phase 1/2 study testing Formocresol and Allium Sativum Oil in people with Non-Vital Tooth, run by University of Health Sciences Lahore at 1 site in Pakistan.
Trial summary
The purpose of this randomized controlled clinical trial is to use Allium sativum oil as non-vital Pulpotomy medicament compared to Formocresol in primary teeth by evaluating its antibacterial effect against Streptococcus mutans and Lactobacillus acidophilus. Read more about this study
- Who is it for?
- Ages 4 to 8 yearsHealthy volunteers can take part
- Conditions the study is for
- Non-Vital Tooth
- What is being tested?
- Formocresol and Allium Sativum Oil
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 sitePakistan
- Study dates
- 20 Oct 2022to 2 Mar 2023
- Phase
- Phase 1/2
- 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 4 to 8 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Cooperation of patients and consent of parents.
- Patients with ASA classification I and II (mild to moderate systemic disease).
- Non-traumatic extensively carious hence restorable primary molars.
- No history of antibiotic use for 2 weeks.
- Presence of following clinical signs or symptoms suggestive of non-vital tooth such as tenderness on percussion, non-responsive to cold test, periapical/furcal radiolucency, localized gingival/mucosal soreness/redness/swelling, and/or slight mobility-grade I.
Who cannot join
- History of allergy to anesthetics and latex.
- Radiographic evidence of pulpal floor opening into the furcation area.
- More than half of the roots resorbed.
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
de' Montmorency College of dentistry
Lahore, Punjab Province, 54000
About this study
Official title: Allium Sativum Oil as Alternative Non-vital Pulpotomy Medicament in Primary Teeth- A Randomized Controlled Trial
The purpose of this randomized controlled clinical trial is to use Allium sativum oil as non-vital Pulpotomy medicament compared to Formocresol in primary teeth by evaluating its antibacterial effect against Streptococcus mutans and Lactobacillus acidophilus. It is hypothesized that there is no difference in the antibacterial effect of Allium sativum oil compared with Formocresol, when used as non-vital Pulpotomy medicaments.
Read the detailed description
It is a multi-arm parallel Randomized Controlled Trial in which forty patients aged between 4 to 8 years, each containing at-least one non-vital primary molar, will be selected and randomly divided into Group A (Formocresol) and Group B (Allium sativum oil). Non-vital Pulpotomy will be performed by removing the coronal necrotic pulp. Sterile paper point will be dipped in the root canals and taken to the laboratory. Cotton pellets soaked in the respective medicaments will be placed over the root canal orifices and filled temporarily. Patients will be recalled after one week. Samples will be again taken, and tooth restored. Comparison between bacterial count at baseline and after one week of treatment will be made and expressed as Colony-Forming Units/ml (CFU/ml).
- Conditions
- Non-Vital Tooth
- Being tested
- Formocresol, Allium Sativum Oil
- Medical subject headings
- Tooth, Nonvital
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FormocresolDrug
Also called medicament for Non-vital pulpotomy procedure
Formocresol will be used as non-vital pulpotomy medicament (which is gold standard)
Allium Sativum OilDrug
Also called medicament for Non-vital pulpotomy procedure
Allium sativum oil will be used as non-vital pulpotomy medicament compared with Formocresol (which is gold standard)
| Study group | Role | What they receive |
|---|---|---|
| Formocresol (Control-Gold standard-Group A) | Active comparator | Premade Formocresol (Tricresol \& Formalin) will be used in this research. Composition was Tricresol 35%, Formaldehyde (40%) 19%, excipient additive 100% (PD, Switzerland, ISO9001/ISO9001_2000/ ISO13485/CE_MARK), (Universal Dental Pvt, Ltd) Receives: Drug: Formocresol |
| Allium sativum oil (Experimental-Group B) | Experimental | Premade Allium sativum oil (Garlic oil) (Mohammad and Baroudi, 2015b) will be used in this research (SAC group of companies-9001:2015 certified; Registration # PAK17.1724-U; NTN # 0299739-8, Karachi, Pakistan Receives: Drug: Allium Sativum Oil |
What is being measured
The primary outcome is the main question the study is designed to answer.
Antibacterial effect
Bacterial count of S. mutans and L. acidophilus counted as Colony Forming Units/ml (CFU/ml)
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2023
- Study start20 Oct 2022
- Primary completion23 Feb 2023
- Study completion2 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-Vital ToothStudies of the same condition, open and under way.
- More trials run by University of Health Sciences LahoreThe sponsor's other registered studies.
- 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Health Sciences Lahore
- Sponsor type
- University, hospital or other
- Collaborators
- Lahore General Hospital
- Responsible party
- Principal investigator, Dr. Mashal Mazhar, University of Health Sciences Lahore
- Investigators
- Shazia Naz, BDS, MDS, Principal investigator, Assistant professor operative dentistry de, Montmorency College of Dentistry
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05801367
- Sponsor's protocol ID
- UniversityUHS
- Status last verified
- Mar 2023
- First submitted
- 28 Feb 2023
- Last updated
- 6 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Allium Sativum Oil as Alternative Non-vital Pulpotomy Medicament in Primary Teeth- A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05801367
- Acronym / sponsor ID
- UniversityUHS
- Conditions
- Non-Vital Tooth
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University of Health Sciences LahoreUniversity, hospital or other
- Collaborators
- Lahore General Hospital
- Study start
- 20 Oct 2022 (actual)
- Primary completion
- 23 Feb 2023 (actual)
- Study completion
- 2 Mar 2023 (actual)
- First posted
- 6 Apr 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 purpose of this randomized controlled clinical trial is to use Allium sativum oil as non-vital Pulpotomy medicament compared to Formocresol in primary teeth by evaluating its antibacterial effect against Streptococcus mutans and Lactobacillus acidophilus. It is hypothesized that there is no difference in the antibacterial effect of Allium sativum oil compared with Formocresol, when used as non-vital Pulpotomy medicaments.
Detailed description
It is a multi-arm parallel Randomized Controlled Trial in which forty patients aged between 4 to 8 years, each containing at-least one non-vital primary molar, will be selected and randomly divided into Group A (Formocresol) and Group B (Allium sativum oil). Non-vital Pulpotomy will be performed by removing the coronal necrotic pulp. Sterile paper point will be dipped in the root canals and taken to the laboratory. Cotton pellets soaked in the respective medicaments will be placed over the root canal orifices and filled temporarily. Patients will be recalled after one week. Samples will be again taken, and tooth restored. Comparison between bacterial count at baseline and after one week of treatment will be made and expressed as Colony-Forming Units/ml (CFU/ml).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Formocresol (Control-Gold standard-Group A) | Active comparator | Drug: FormocresolPremade Formocresol (Tricresol \& Formalin) will be used in this research. Composition was Tricresol 35%, Formaldehyde (40%) 19%, excipient additive 100% (PD, Switzerland, ISO9001/ISO9001_2000/ ISO13485/CE_MARK), (Universal Dental Pvt, Ltd) |
| Allium sativum oil (Experimental-Group B) | Experimental | Drug: Allium Sativum OilPremade Allium sativum oil (Garlic oil) (Mohammad and Baroudi, 2015b) will be used in this research (SAC group of companies-9001:2015 certified; Registration # PAK17.1724-U; NTN # 0299739-8, Karachi, Pakistan |
Who may qualify
- Ages
- 4 to 8 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Cooperation of patients and consent of parents.
- Patients with ASA classification I and II (mild to moderate systemic disease).
- Non-traumatic extensively carious hence restorable primary molars.
- No history of antibiotic use for 2 weeks.
- Presence of following clinical signs or symptoms suggestive of non-vital tooth such as tenderness on percussion, non-responsive to cold test, periapical/furcal radiolucency, localized gingival/mucosal soreness/redness/swelling, and/or slight mobility-grade I.
Key exclusion criteria (3 listed)
- History of allergy to anesthetics and latex.
- Radiographic evidence of pulpal floor opening into the furcation area.
- More than half of the roots resorbed.
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 |
|---|---|---|
| FormocresolAlso: medicament for Non-vital pulpotomy procedureFormocresol will be used as non-vital pulpotomy medicament (which is gold standard) | Drug | Formocresol (Control-Gold standard-Group A) |
| Allium Sativum OilAlso: medicament for Non-vital pulpotomy procedureAllium sativum oil will be used as non-vital pulpotomy medicament compared with Formocresol (which is gold standard) | Drug | Allium sativum oil (Experimental-Group B) |
Primary outcome
Antibacterial effect
Time frame: 1 week
Bacterial count of S. mutans and L. acidophilus counted as Colony Forming Units/ml (CFU/ml)
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 6 Apr 2023.
- Individual participant dataSharing planned: No
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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.
Shazia Naz, BDS, MDS principal investigator
Assistant professor operative dentistry de, Montmorency College of Dentistry
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Formocresol and Allium Sativum Oil in people with Non-Vital Tooth, run by University of Health Sciences Lahore at 1 site in Pakistan.
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 5 inclusion and 3 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 6 Apr 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 Pakistan. 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.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Antibacterial effect (time frame: 1 week). 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 6 Apr 2023.