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

NCT05050071 | Completed Phase 2 DMC FDA Drug FDA Device

• 1 other identifier: 228/2019
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

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.

Conditions

Drug Effect

Keywords

Calcium hydroxide; Enterococcus faecalis; Garlic; Intra-canal medication; Streptococcus; Quantitative real-time polymerase chain reaction

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• 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

Study Arms (6)

Calcium hydroxide (7 days)

ACTIVE COMPARATOR

is also known as slaked lime or calcium hydrate. It is produced by the hydration of lime

Drug: Allium Sativum; Device: Polymerase chain reaction

Allium sativum (7 days)

EXPERIMENTAL

is a species of bulbous flowering plant in the onion genus Allium

Drug: Allium Sativum; Device: Polymerase chain reaction

Combination (7 days)

EXPERIMENTAL

combination between Calcium hydroxide and Allium sativum

Drug: Allium Sativum; Device: Polymerase chain reaction

Calcium hydroxide (14 days)

ACTIVE COMPARATOR

is also known as slaked lime or calcium hydrate. It is produced by the hydration of lime

Drug: Allium Sativum; Device: Polymerase chain reaction

Allium sativum (14 days)

EXPERIMENTAL

is a species of bulbous flowering plant in the onion genus Allium

Drug: Allium Sativum; Device: Polymerase chain reaction

Combination (14 days)

EXPERIMENTAL

combination between Calcium hydroxide and Allium sativum

Drug: Allium Sativum; Device: Polymerase chain reaction

Interventions

Allium Sativum DRUG

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.

Also known as: Combination of Allium Sativum and Calcium hydroxide, Calcium hydroxide

Allium sativum (14 days); Allium sativum (7 days); Calcium hydroxide (14 days); Calcium hydroxide (7 days); Combination (14 days); Combination (7 days)

Polymerase chain reaction DEVICE

Change in the bacterial load in response to different treatment procedures

Allium sativum (14 days); Allium sativum (7 days); Calcium hydroxide (14 days); Calcium hydroxide (7 days); Combination (14 days); Combination (7 days)

Eligibility Criteria

• Age: 10 Years - 13 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Cooperative male children with age ranging from 10 to 13 years.
• All patients should have pulp necrosis with apical periodontitis in one or more upper incisor(s).
• 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.

You may not qualify if:

• immune-compromised patient or patient with complicating systemic disease.
• Patients received antibiotic therapy within the previous 3 months.
• Tooth having gross carious lesions, fractures or cracks involving the periodontium (un-restorable tooth).
• Tooth with root canal calcifications or resorption
• Tooth with periodontal pockets of more than 4 mm depth, with or without endo-perio communication either concomitant or combined.

Sponsors & Collaborators

• Suez Canal University: lead

Study Sites (1)

Suez Canal University

Ismailia, 52241, Egypt

Location

MeSH Terms

Interventions

Calcium Hydroxide; Polymerase Chain Reaction

Intervention Hierarchy (Ancestors)

Hydroxides; Alkalies; Inorganic Chemicals; Calcium Compounds; Anions; Ions; Electrolytes; Nucleic Acid Amplification Techniques; Genetic Techniques; Investigative Techniques

Study Officials

• Shaimaa M. Mahfouz, PhD

  Suez Canal University, Ismailia, Egypt

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle Investigator

Study Record Dates

• First Submitted: August 12, 2021
• First Posted: September 20, 2021
• Study Start: October 8, 2019
• Primary Completion: October 8, 2020
• Study Completion: July 17, 2021
• Last Updated: September 20, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: for 1 month

Locations

EG (1)