Evaluation of Antibacterial Effect of Allium Sativum, Calcium Hydroxide and Their Combination in Infected Mature Teeth (Garlic)

Comparative Evaluation of Antibacterial Effect of Allium Sativum, Calcium Hydroxide and Their Combination as Intracanal Medicaments in Infected Mature Teeth. A Randomized Control Trial

This study was to evaluate and compare garlic extract antibacterial effect when used as an intra-canal medicament in infected mature anterior teeth with calcium hydroxide and a mixture of calcium hydroxide and garlic, using real time PCR analysis.

Study Overview

• Status: Completed
• Conditions: Drug Effect
• Intervention / Treatment: Drug: Allium Sativum; Device: Polymerase chain reaction

Detailed Description

Sixty-six permanent mature necrotic incisors associated with apical periodontitis in male children were selected. Teeth were randomly divided into three groups (n=22) according to intra canal medications used; group I: Ca OH2, group II: garlic extract and group III: mixture of Ca OH2 and garlic extract. After access preparation, four microbiological samples (S) were taken using sterile absorbent paper points as follows; (S1): were taken before canal instrumentation and irrigation. (S2): after cleaning and shaping, Then, the third samples (S3) and forth samples (S4) were taken after placement of the tested intracanal medications into the corresponding canals, for 7 and 14 days respectively. Total DNA was extracted from microbiological samples and relative quantitive real time PCR reactions were done to quantify the relative gene expression levels (FC) for Streptococcus and Enterococcus faecalis species. Data was statistically analyzed using Kruskal-Wallis and Freidman's tests, followed by Mann-Whitney and Wilcoxon singed rank tests at significance level p ≤ 0.05.

• Study Type: Interventional
• Enrollment (Actual): 48
• Phase: Phase 2; Phase 3

Contacts and Locations

Study Locations

• Egypt
  • Ismailia, Egypt, 52241
    • Suez Canal University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 10 years to 13 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

Inclusion Criteria:

1. Cooperative male children with age ranging from 10 to 13 years.
2. All patients should have pulp necrosis with apical periodontitis in one or more upper incisor(s).
3. Teeth included in the study were preliminarily evaluated by preoperative periapical radiographs and should have: single canal (type I vertucci's classification) with closed apices, periapical lesions of endodontic origin with a diameter ranging from 2 to 5 mm without any previous RCT procedure.

Exclusion Criteria:

1. immune-compromised patient or patient with complicating systemic disease.
2. Patients received antibiotic therapy within the previous 3 months.
3. Tooth having gross carious lesions, fractures or cracks involving the periodontium (un-restorable tooth).
4. Tooth with root canal calcifications or resorption

6- Tooth with periodontal pockets of more than 4 mm depth, with or without endo-perio communication either concomitant or combined.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

6

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Calcium hydroxide (7 days); is also known as slaked lime or calcium hydrate. It is produced by the hydration of lime	Drug: Allium Sativum; Sixty-six permanent mature necrotic incisors associated with apical periodontitis in male children were selected. Teeth were randomly divided into three groups (n=22) according to intra canal medications used; group I: Ca OH2, group II: garlic extract and group III: mixture of Ca OH2 and garlic extract. After access preparation, four microbiological samples (S) were as follows; (S1): were taken before canal instrumentation and irrigation. (S2): after cleaning and shaping, Then, the third samples (S3) and forth samples (S4) were taken after placement of the tested intracanal medications into the corresponding canals, for 7 and 14 days respectively. Total DNA was extracted from microbiological samples and relative quantitive real time PCR reactions were done to quantify the relative gene expression levels (FC) for Streptococcus and Enterococcus faecalis species.; Other Names: Combination of Allium Sativum and Calcium hydroxide; Calcium hydroxide; Device: Polymerase chain reaction; Change in the bacterial load in response to different treatment procedures
Experimental: Allium sativum (7 days); is a species of bulbous flowering plant in the onion genus Allium	Drug: Allium Sativum; Sixty-six permanent mature necrotic incisors associated with apical periodontitis in male children were selected. Teeth were randomly divided into three groups (n=22) according to intra canal medications used; group I: Ca OH2, group II: garlic extract and group III: mixture of Ca OH2 and garlic extract. After access preparation, four microbiological samples (S) were as follows; (S1): were taken before canal instrumentation and irrigation. (S2): after cleaning and shaping, Then, the third samples (S3) and forth samples (S4) were taken after placement of the tested intracanal medications into the corresponding canals, for 7 and 14 days respectively. Total DNA was extracted from microbiological samples and relative quantitive real time PCR reactions were done to quantify the relative gene expression levels (FC) for Streptococcus and Enterococcus faecalis species.; Other Names: Combination of Allium Sativum and Calcium hydroxide; Calcium hydroxide; Device: Polymerase chain reaction; Change in the bacterial load in response to different treatment procedures
Experimental: Combination (7 days); combination between Calcium hydroxide and Allium sativum	Drug: Allium Sativum; Sixty-six permanent mature necrotic incisors associated with apical periodontitis in male children were selected. Teeth were randomly divided into three groups (n=22) according to intra canal medications used; group I: Ca OH2, group II: garlic extract and group III: mixture of Ca OH2 and garlic extract. After access preparation, four microbiological samples (S) were as follows; (S1): were taken before canal instrumentation and irrigation. (S2): after cleaning and shaping, Then, the third samples (S3) and forth samples (S4) were taken after placement of the tested intracanal medications into the corresponding canals, for 7 and 14 days respectively. Total DNA was extracted from microbiological samples and relative quantitive real time PCR reactions were done to quantify the relative gene expression levels (FC) for Streptococcus and Enterococcus faecalis species.; Other Names: Combination of Allium Sativum and Calcium hydroxide; Calcium hydroxide; Device: Polymerase chain reaction; Change in the bacterial load in response to different treatment procedures
Active Comparator: Calcium hydroxide (14 days); is also known as slaked lime or calcium hydrate. It is produced by the hydration of lime	Drug: Allium Sativum; Sixty-six permanent mature necrotic incisors associated with apical periodontitis in male children were selected. Teeth were randomly divided into three groups (n=22) according to intra canal medications used; group I: Ca OH2, group II: garlic extract and group III: mixture of Ca OH2 and garlic extract. After access preparation, four microbiological samples (S) were as follows; (S1): were taken before canal instrumentation and irrigation. (S2): after cleaning and shaping, Then, the third samples (S3) and forth samples (S4) were taken after placement of the tested intracanal medications into the corresponding canals, for 7 and 14 days respectively. Total DNA was extracted from microbiological samples and relative quantitive real time PCR reactions were done to quantify the relative gene expression levels (FC) for Streptococcus and Enterococcus faecalis species.; Other Names: Combination of Allium Sativum and Calcium hydroxide; Calcium hydroxide; Device: Polymerase chain reaction; Change in the bacterial load in response to different treatment procedures
Experimental: Allium sativum (14 days); is a species of bulbous flowering plant in the onion genus Allium	Drug: Allium Sativum; Sixty-six permanent mature necrotic incisors associated with apical periodontitis in male children were selected. Teeth were randomly divided into three groups (n=22) according to intra canal medications used; group I: Ca OH2, group II: garlic extract and group III: mixture of Ca OH2 and garlic extract. After access preparation, four microbiological samples (S) were as follows; (S1): were taken before canal instrumentation and irrigation. (S2): after cleaning and shaping, Then, the third samples (S3) and forth samples (S4) were taken after placement of the tested intracanal medications into the corresponding canals, for 7 and 14 days respectively. Total DNA was extracted from microbiological samples and relative quantitive real time PCR reactions were done to quantify the relative gene expression levels (FC) for Streptococcus and Enterococcus faecalis species.; Other Names: Combination of Allium Sativum and Calcium hydroxide; Calcium hydroxide; Device: Polymerase chain reaction; Change in the bacterial load in response to different treatment procedures
Experimental: Combination (14 days); combination between Calcium hydroxide and Allium sativum	Drug: Allium Sativum; Sixty-six permanent mature necrotic incisors associated with apical periodontitis in male children were selected. Teeth were randomly divided into three groups (n=22) according to intra canal medications used; group I: Ca OH2, group II: garlic extract and group III: mixture of Ca OH2 and garlic extract. After access preparation, four microbiological samples (S) were as follows; (S1): were taken before canal instrumentation and irrigation. (S2): after cleaning and shaping, Then, the third samples (S3) and forth samples (S4) were taken after placement of the tested intracanal medications into the corresponding canals, for 7 and 14 days respectively. Total DNA was extracted from microbiological samples and relative quantitive real time PCR reactions were done to quantify the relative gene expression levels (FC) for Streptococcus and Enterococcus faecalis species.; Other Names: Combination of Allium Sativum and Calcium hydroxide; Calcium hydroxide; Device: Polymerase chain reaction; Change in the bacterial load in response to different treatment procedures

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Test the antibacterial efficiency of Garlic extract as intracanal medicament in comparison to Calcium hydroxide and their combinations , against E.faecalis and streptococcus bacteria using qRT-PCR analysis.	The change in the mean relative gene expression (bacterial load), for E.faecalis and streptococcus species was measured using quantitative real time polymerase chain reaction (qRT-PCR) after placement garlic (Allium Sativum), Calcium hydroxide and their combinations for one week, in infected single rooted anterior teeth. Statistical analysis was done to compare between the tested medicaments	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Test the antibacterial effect of increasing the contact time (14 days) for garlic (Allium Sativum), Calcium hydroxide or their combinations inside infected root canals, against E.faecalis and streptococcus bacteria using qRT-PCR analysis.	The change in the mean relative gene expression (bacterial load), for E.faecalis and streptococcus species was measured using quantitative real time polymerase chain reaction (qRT-PCR) after placement garlic (Allium Sativum), Calcium hydroxide and their combinations for two weeks, in infected single rooted anterior teeth. Statistical analysis was done to compare between the tested medicaments.	12 months

Collaborators and Investigators

• Sponsor: Suez Canal University
• Investigators: Principal Investigator: Shaimaa M. Mahfouz, PhD, Suez Canal University, Ismailia, Egypt

Study record dates

Study Major Dates

• Study Start (Actual): October 8, 2019
• Primary Completion (Actual): October 8, 2020
• Study Completion (Actual): July 17, 2021

Study Registration Dates

• First Submitted: August 12, 2021
• First Submitted That Met QC Criteria: September 9, 2021
• First Posted (Actual): September 20, 2021

Study Record Updates

• Last Update Posted (Actual): September 20, 2021
• Last Update Submitted That Met QC Criteria: September 9, 2021
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Keywords: Calcium hydroxide; Enterococcus faecalis; Garlic; Intra-canal medication; Streptococcus; Quantitative real-time polymerase chain reaction
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Bone Density Conservation Agents; Calcium-Regulating Hormones and Agents; Calcium; Calcium, Dietary
• Other Study ID Numbers: 228/2019

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: Protocol & Conclusion
• IPD Sharing Time Frame: for 1 month
• IPD Sharing Supporting Information Type: Study Protocol; Statistical Analysis Plan (SAP)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No