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Completed

NCT Number: NCT05050071

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

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.

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Key information

Conditions

Age range

10 year–13 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Suez Canal University

Ismailia, 52241, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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

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

Treatment and study plan

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.

Other names: Combination of Allium Sativum and Calcium hydroxide, Calcium hydroxide

Polymerase chain reaction

Device

Change in the bacterial load in response to different treatment procedures

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.

    Time frame: 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 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.

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Suez Canal University

Other

Registry information

Official study 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

Acronym: Garlic

Important dates

Study start
2019
Primary completion
2020
Study completion
2021
First posted
Sep 20, 2021
Registry last updated
Sep 20, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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