Allium Sativum Oil as Alternative Non-vital Pulpotomy Medicament in Primary Teeth

Study Overview
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Brief Summary
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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.

Detailed Description
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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).

Official Title
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Allium Sativum Oil as Alternative Non-vital Pulpotomy Medicament in Primary Teeth- A Randomized Controlled Trial

Conditions
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Non-Vital Tooth

Intervention / Treatment
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* Drug: Formocresol
* Drug: Allium Sativum Oil


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: History of allergy to anesthetics and latex. Radiographic evidence of pulpal floor opening into the furcation area. More than half of the roots resorbed.

Ages Eligible for Study
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Minimum Age: 4 Years
Maximum Age: 8 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Formocresol (Control-Gold standard-Group A)<br>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) | Drug: Formocresol<br>* Formocresol will be used as non-vital pulpotomy medicament (which is gold standard)<br>* Other names: medicament for Non-vital pulpotomy procedure;|
| Experimental: Allium sativum oil (Experimental-Group B)<br>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 | Drug: Allium Sativum Oil<br>* Allium sativum oil will be used as non-vital pulpotomy medicament compared with Formocresol (which is gold standard)<br>* Other names: medicament for Non-vital pulpotomy procedure;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Antibacterial effect | Bacterial count of S. mutans and L. acidophilus counted as Colony Forming Units/ml (CFU/ml) | 1 week |