Allium Sativum Extract as an Irrigant

Study Overview
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Brief Summary
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Garlic extract as herbal compound has potent antibacterial properties and can be used safely as an irrigant for pulpectomy procedure of primary molars root canals with high clinical and radiographic outcomes

Detailed Description
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Aim: This study indented to assess the clinical and radiographic assessment of garlic extract as an intracanal irrigant for pulpectomy of primary molars. Methodology: 91 child with 100 teeth submitted into this study were equally categorized into the test group (group 1) which irrigated with garlic extract and control group (group 2) that received sodium hypochlorite (NaOCl). Then, each group has been subjected to further specification according to the tooth preoperative clinical and radiographic features into has been into 2 subgroups. Clinical and radiographic success rates were checked at 3, 6 and 12 months. Fisher's exact test for binary variable was used for data analysis with p-value ≤ 0.05.

Official Title
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Allium Sativum Extract as an Irrigant in Pulpectomy of Primary Molars: 12 Month In-vivo Study

Conditions
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Infected Root Canals of Primary Molars

Intervention / Treatment
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* Other: Garlic extract
* Other: NaOCl (COLTENE®)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Class I or II according to American Society of Anesthesiologists (ASA) Irreversible pulpititis recognised through; (1) profuse bleeding from root canal orifices after complete debridement of coronal pulp tissue and cannot be dominated by moist cotton pellet. (2) History of lingered thermal pain spontaneous nocturnal pain Necrotic pulp tissues which may be asymptomatic or manifested with dull ache pain Pathological tooth mobility Percussion sensitivity Swelling close to involved tooth accompanied with or without fistula Radiographic characteristics of the root and supporting structures 1. Normal radiographic findings 2. Interruption of lamina dura 3. Furcation radiolucency Exclusion Criteria: Specifications of exclusion Uncooperativeness of child and/or parents or caregivers behavior Unrestorable tooth Presence of internal root resorption Presence of calcific metamorphosis inside root canals Presence of root resorption exceeding one third of its length

Ages Eligible for Study
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Minimum Age: 4 Years
Maximum Age: 6 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 |
| --- | --- |
| Experimental: Garlic extracts root canal irrigation group<br>Experimental group treated with garlic extract A 100 gram of garlic cloves has been cleaned, peeled and dried. Ethanol of 70% concentration was added for 60 seconds. The cloves were placed in a laminar airflow chamber for evaporation of residual ethanol. Using a sterile mortar and pestle, cloves were homogenized aseptically and filtered through a double layer paper. The fully concentrated extracted was diluted to the concentration of 25% with distilled water | Other: Garlic extract<br>* A 100 gram of garlic cloves has been cleaned, peeled and dried. Ethanol of 70% concentration was added for 60 seconds. The cloves were placed in a laminar airflow chamber for evaporation of residual ethanol. Using a sterile mortar and pestle, cloves were homogenized aseptically and filtered through a double layer paper. The fully concentrated extracted was diluted to the concentration of 25% with distilled water<br>|
| Active Comparator: Sodium hypochlorite root canal irrigation group<br>Control group which treated conventionally using .5 ml of 5.25% NaOCl (COLTENE®ENDO, Switzerland) | Other: NaOCl (COLTENE®)<br>* Sodium hypochlorite<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| oral examination | Pain assessment using Visual Analog Score for pain | 12 months | 
| radiographic success or failure | Radiographic assessment using periapical radiograph and score (0) applied for absence of radiolucency and score (1) for presence of radiolucency | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Types of failures | detecting the percent of different failure types accompanied with pulpectomy procedures after using garlic as an irrigant solution. | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Primary molars, Garlic extract, Sodium hypochlorite, Pulpectomy