Allium Sativum Extract as an Irrigant

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

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

Study Overview

• Status: Completed
• Conditions: Infected Root Canals of Primary Molars
• Intervention / Treatment: Other: Garlic extract; Other: NaOCl (COLTENE®)

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 91
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 4 years to 6 years (Child)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Class I or II according to American Society of Anesthesiologists (ASA)
2. 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
3. Necrotic pulp tissues which may be asymptomatic or manifested with dull ache pain
4. Pathological tooth mobility
5. Percussion sensitivity
6. 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

  1. Uncooperativeness of child and/or parents or caregivers behavior
  2. Unrestorable tooth
  3. Presence of internal root resorption
  4. Presence of calcific metamorphosis inside root canals
  5. Presence of root resorption exceeding one third of its length

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Garlic extracts root canal irrigation group; 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; 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
Active Comparator: Sodium hypochlorite root canal irrigation group; Control group which treated conventionally using .5 ml of 5.25% NaOCl (COLTENE®ENDO, Switzerland)	Other: NaOCl (COLTENE®); Sodium hypochlorite

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Minia University

Publications and helpful links

General Publications

• Elheeny AAH. Allium sativum extract as an irrigant in pulpectomy of primary molars: A 12-month short-term evaluation. Clin Exp Dent Res. 2019 Jun 26;5(4):420-426. doi: 10.1002/cre2.197. eCollection 2019 Aug.

Study record dates

Study Major Dates

• Study Start (Actual): October 30, 2016
• Primary Completion (Actual): August 13, 2018
• Study Completion (Actual): August 15, 2018

Study Registration Dates

• First Submitted: January 2, 2019
• First Submitted That Met QC Criteria: January 7, 2019
• First Posted (Actual): January 8, 2019

Study Record Updates

• Last Update Posted (Actual): October 25, 2019
• Last Update Submitted That Met QC Criteria: October 23, 2019
• Last Verified: October 1, 2019

More Information

Terms related to this study

• Keywords: Pulpectomy; Primary molars; Sodium hypochlorite; Garlic extract
• Other Study ID Numbers: 307

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated device product: No