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| Name | Class |
|---|---|
| Lahore General Hospital | OTHER_GOV |
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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.
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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) |
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| 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 |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Formocresol | Drug | Formocresol will be used as non-vital pulpotomy medicament (which is gold standard) |
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| Measure | Description | Time Frame |
|---|---|---|
| Antibacterial effect | Bacterial count of S. mutans and L. acidophilus counted as Colony Forming Units/ml (CFU/ml) | 1 week |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Shazia Naz, BDS, MDS | Assistant professor operative dentistry de, Montmorency College of Dentistry | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| de' Montmorency College of dentistry | Lahore | Punjab Province | 54000 | Pakistan |
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| ID | Term |
|---|---|
| D019553 | Tooth, Nonvital |
| ID | Term |
|---|---|
| D003788 | Dental Pulp Diseases |
| D014076 | Tooth Diseases |
| D009057 | Stomatognathic Diseases |
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| ID | Term |
|---|---|
| C031025 | formocresol |
| C038491 | allyl sulfide |
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patients and assessors involved in the study from randomization, allocation, bacteriological outcome, and data analysis will be blinded to which medicament group the patients belonged as all data will be coded.
| Allium Sativum Oil | Drug | Allium sativum oil will be used as non-vital pulpotomy medicament compared with Formocresol (which is gold standard) |
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