Clinical trial NCT05050071: Evaluation of Antibacterial Effect of Allium Sativum, Calcium Hydroxide and Their Combination in Infected Mature Teeth
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Drug Effect
Keywords: Calcium hydroxide
Enterococcus faecalis
Garlic
Intra-canal medication
Streptococcus
Quantitative real-time polymerase chain reaction
Lead sponsor: Suez Canal University
Sponsor class: OTHER
First posted: 2021-09-20
Enrollment: 48
Sex: MALE
Minimum age (years): 10
Maximum age (years): 13
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: 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.
timeFrame: 12 months
Secondary outcomes:
measure: 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.
timeFrame: 12 months
Other outcomes:
Locations:
city: Ismailia
country: Egypt
facility: Suez Canal University
Study officials:
affiliation: Suez Canal University, Ismailia, Egypt
name: Shaimaa M. Mahfouz, PhD
role: PRINCIPAL_INVESTIGATOR
References: