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

Phase 2

Completed

• Conditions: Drug Effect
• Interventions: Drug: Allium Sativum; Device: Polymerase chain reaction

• Registration Number: NCT05050071
• Lead Sponsor: Suez Canal University

Brief 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.

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 Timeline

• Study Start: 2019-10-08
• Primary Completion: 2020-10-08
• Study Completion: 2021-07-17
• Study First Submitted: 2021-08-12
• Status Verified: 2021-09
• Study First Submitted QC: 2021-09-09
• Last Update Submitted: 2021-09-09
• Study First Posted: 2021-09-20
• Last Update Posted: 2021-09-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 48

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Allium sativum (7 days)	Polymerase chain reaction	is a species of bulbous flowering plant in the onion genus Allium
Combination (7 days)	Allium Sativum	combination between Calcium hydroxide and Allium sativum
Combination (7 days)	Polymerase chain reaction	combination between Calcium hydroxide and Allium sativum
Calcium hydroxide (7 days)	Allium Sativum	is also known as slaked lime or calcium hydrate. It is produced by the hydration of lime
Calcium hydroxide (7 days)	Polymerase chain reaction	is also known as slaked lime or calcium hydrate. It is produced by the hydration of lime
Allium sativum (7 days)	Allium Sativum	is a species of bulbous flowering plant in the onion genus Allium
Calcium hydroxide (14 days)	Allium Sativum	is also known as slaked lime or calcium hydrate. It is produced by the hydration of lime
Calcium hydroxide (14 days)	Polymerase chain reaction	is also known as slaked lime or calcium hydrate. It is produced by the hydration of lime
Allium sativum (14 days)	Allium Sativum	is a species of bulbous flowering plant in the onion genus Allium
Allium sativum (14 days)	Polymerase chain reaction	is a species of bulbous flowering plant in the onion genus Allium
Combination (14 days)	Allium Sativum	combination between Calcium hydroxide and Allium sativum
Combination (14 days)	Polymerase chain reaction	combination between Calcium hydroxide and Allium sativum

Primary Outcome Measures

Name	Time	Method
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.	12 months	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

Secondary Outcome Measures

Name	Time	Method
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.	12 months	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.

Trial Locations

Locations (1)

Suez Canal University; 🇪🇬 Ismailia, Egypt