Drug EffectPhase 2/3GarlicNCT05050071
Evaluation of Antibacterial Effect of Allium Sativum, Calcium Hydroxide and Their Combination in Infected Mature Teeth
A Phase 2/3 study testing Allium Sativum and Polymerase chain reaction in people with Drug Effect, run by Suez Canal University at 1 site in Egypt.
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. Read more about this study
- Who is it for?
- Ages 10 to 13 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Drug Effect
- What is being tested?
- Allium Sativum and Polymerase chain reaction
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteEgypt
- Study dates
- 8 Oct 2019to 17 Jul 2021
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 to 13 years
- Men only
- Healthy volunteers accepted
- Child
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Conditions
- Drug Effect
- Being tested
- Allium Sativum, Polymerase chain reaction
- Keywords
- Calcium hydroxide, Enterococcus faecalis, Garlic, Intra-canal medication, Streptococcus, Quantitative real-time polymerase chain reaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Allium SativumDrug
Also called Combination of Allium Sativum and Calcium hydroxide, Calcium hydroxide
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.
Polymerase chain reactionDevice
Change in the bacterial load in response to different treatment procedures
| Study group | Role | What they receive |
|---|---|---|
| Calcium hydroxide (7 days) | Active comparator | is also known as slaked lime or calcium hydrate. It is produced by the hydration of lime Receives: Drug: Allium Sativum; Device: Polymerase chain reaction |
| Allium sativum (7 days) | Experimental | is a species of bulbous flowering plant in the onion genus Allium Receives: Drug: Allium Sativum; Device: Polymerase chain reaction |
| Combination (7 days) | Experimental | combination between Calcium hydroxide and Allium sativum Receives: 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 Receives: Drug: Allium Sativum; Device: Polymerase chain reaction |
| Allium sativum (14 days) | Experimental | is a species of bulbous flowering plant in the onion genus Allium Receives: Drug: Allium Sativum; Device: Polymerase chain reaction |
| Combination (14 days) | Experimental | combination between Calcium hydroxide and Allium sativum Receives: Drug: Allium Sativum; Device: Polymerase chain reaction |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
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.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2021
- Study start8 Oct 2019
- Primary completion8 Oct 2020
- Study completion17 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Drug EffectStudies of the same condition, open and under way.
- More trials run by Suez Canal UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Suez Canal University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Reham Mohamed, Suez Canal University
- Investigators
- Shaimaa M. Mahfouz, PhD, Principal investigator, Suez Canal University, Ismailia, Egypt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05050071
- Sponsor's protocol ID
- 228/2019
- Acronym
- Garlic
- Status last verified
- Sep 2021
- First submitted
- 12 Aug 2021
- Last updated
- 20 Sep 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: Protocol \& Conclusion
Study at a glance
From the registry record, last updated by the sponsor on 20 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05050071
- Acronym / sponsor ID
- Garlic / 228/2019
- Conditions
- Drug Effect
- Keywords
- Calcium hydroxide, Enterococcus faecalis, Garlic, Intra-canal medication, Streptococcus, Quantitative real-time polymerase chain reaction
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Suez Canal UniversityUniversity, hospital or other
- Study start
- 8 Oct 2019 (actual)
- Primary completion
- 8 Oct 2020 (actual)
- Study completion
- 17 Jul 2021 (actual)
- First posted
- 20 Sep 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Calcium hydroxide (7 days) | Active comparator | Drug: Allium Sativum, Device: Polymerase chain reactionis also known as slaked lime or calcium hydrate. It is produced by the hydration of lime |
| Allium sativum (7 days) | Experimental | Drug: Allium Sativum, Device: Polymerase chain reactionis a species of bulbous flowering plant in the onion genus Allium |
| Combination (7 days) | Experimental | Drug: Allium Sativum, Device: Polymerase chain reactioncombination between Calcium hydroxide and Allium sativum |
| Calcium hydroxide (14 days) | Active comparator | Drug: Allium Sativum, Device: Polymerase chain reactionis also known as slaked lime or calcium hydrate. It is produced by the hydration of lime |
| Allium sativum (14 days) | Experimental | Drug: Allium Sativum, Device: Polymerase chain reactionis a species of bulbous flowering plant in the onion genus Allium |
| Combination (14 days) | Experimental | Drug: Allium Sativum, Device: Polymerase chain reactioncombination between Calcium hydroxide and Allium sativum |
Who may qualify
- Ages
- 10 to 13 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Allium SativumAlso: Combination of Allium Sativum and Calcium hydroxide, Calcium hydroxideSixty-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. | Drug | Allium sativum (14 days), Allium sativum (7 days), Calcium hydroxide (14 days), Calcium hydroxide (7 days), Combination (14 days), Combination (7 days) |
| Polymerase chain reactionChange in the bacterial load in response to different treatment procedures | Device | Allium sativum (14 days), Allium sativum (7 days), Calcium hydroxide (14 days), Calcium hydroxide (7 days), Combination (14 days), Combination (7 days) |
Primary outcome
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
1 secondary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Sep 2021.
- Individual participant dataSharing planned: Yes. Protocol \& Conclusion
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shaimaa M. Mahfouz, PhD principal investigator
Suez Canal University, Ismailia, Egypt
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Allium Sativum and Polymerase chain reaction in people with Drug Effect, run by Suez Canal University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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. (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Sep 2021.