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

Drug Effect Clinical Trial

— Garlic  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05050071
• Other study ID #: 228/2019
• Status: Completed
• Phase: Phase 2/Phase 3
• Start date: October 8, 2019
• Est. completion date: July 17, 2021

Study information

• Verified date: September 2021
• Source: Suez Canal University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: July 17, 2021
• Est. primary completion date: October 8, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 10 Years to 13 Years

Eligibility

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.

Related Conditions & MeSH terms

• Drug Effect

Intervention

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.

Device:
• Polymerase chain reaction
Change in the bacterial load in response to different treatment procedures

Locations

Country	Name	City	State
Egypt	Suez Canal University	Ismailia

Sponsors (1)

Lead Sponsor	Collaborator
Suez Canal University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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