Effective Intracanal Medicaments Against Enterococcus FaecalisPhase 2/3NCT06006663
Effect of Hebal and Synthetic Medicamentss on Enterococcus Feacalis
A Phase 2/3 study testing Ibuprofen 400 mg., modified triple antibiotic paste and curcumin in people with Effective Intracanal Medicaments Against Enterococcus Faecalis, run by Tanta University.
Trial summary
this study aims to evaluate the antimicrobial efficacy of two synthetic (Ibuprofen, Modified triple antibiotic paste) and two herbal materials (Curcumin and Olive leaves extract) used as intracanal medication, against E.Faecalis in secondary endodontic infection cases. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Effective Intracanal Medicaments Against Enterococcus Faecalis
- What is being tested?
- Ibuprofen 400 mg., modified triple antibiotic paste and curcumin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- No sites listed yet
- Study dates
- 26 Aug 2023to 10 Dec 2023
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Single rooted teeth.
- Teeth have clinical signs and symptoms of endodontic failure as sensitivity to percussion, pain, swelling or fistula.
- Teeth with radiographic features of endodontic failure as persistent periapical lesion or widening of periodontal ligament.
Who cannot join
- • Teeth with fractures of the crown or root.
- Teeth with periodontal pocket deeper than 4mm.
- Teeth have procedural error like ledge, broken instrument, or perforation.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Antimicrobial Efficacy of Synthetic Versus Herbal Intracanal Medicaments Against Enterococcus Faecalis
this study aims to evaluate the antimicrobial efficacy of two synthetic (Ibuprofen, Modified triple antibiotic paste) and two herbal materials (Curcumin and Olive leaves extract) used as intracanal medication, against E.Faecalis in secondary endodontic infection cases.
Read the detailed description
we evaluate the antimicrobial efficacy of two synthetic (Ibuprofen, Modified triple antibiotic paste) and two herbal materials (Curcumin and Olive leaves extract) used as intracanal medication, against E.Faecalis in secondary endodontic infection cases by taking three samples from root canal , the first sample after removing gutta percha from root canal system, the second sample after shaping with protaper universal files and cleaning with 2.5% sodium hypochlorite , the third sample after 7 days from application of the medication .
samples will be diluted into ten fold serial dilution and then the diluted samples will be cultured on bile esculin agar as it is selective media for enterococcus feacalis.
bacterial reduction will be determined and comparision will be made .
- Being tested
- Ibuprofen 400 mg., modified triple antibiotic paste, curcumin, olive leaves extract
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ibuprofen 400 mg.Drug
synthetic intracanal medicament
modified triple antibiotic pasteDrug
Also called clindamycin, ciprofloxacin and metronidazole
synthetic intracanal medicament
curcuminDietary supplement
herbal intracanal medicament
olive leaves extractDietary supplement
herbal intracanal medicament
| Study group | Role | What they receive |
|---|---|---|
| group 1 | Active comparator | ibuprofen as intracanal medicament Receives: Drug: Ibuprofen 400 mg. |
| group 2 | Active comparator | modified triple antibiotic paste as intracanal medicament Receives: Drug: modified triple antibiotic paste |
| group 3 | Active comparator | curcumin as intracanal medicament Receives: Dietary Supplement: curcumin |
| group 4 | Active comparator | olive leaves as intracanal medicament Receives: Dietary Supplement: olive leaves extract |
What is being measured
The primary outcome is the main question the study is designed to answer.
measurment of microbial reduction as result of applying synthetic and herbaal intracanal medicaments
sample 1 will be taken after gutta percha removal sample 2 will be taken after cleaning and shaping sample 3 will be taken after apllying the intracanal medicament for one week
Measured: time necessary for incubation of each sample is 24 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Aug 2023
- Study start26 Aug 2023 (estimated)
- Primary completion5 Oct 2023 (estimated)
- Study completion10 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Effective Intracanal Medicaments Against Enterococcus FaecalisStudies of the same condition, open and under way.
- More trials run by Tanta 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 32 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tanta University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alaa Essam Ahmed Abo Laimon, Tanta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06006663
- Sponsor's protocol ID
- eliminations of E.faecalis
- Status last verified
- Aug 2023
- First submitted
- 17 Aug 2023
- Last updated
- 23 Aug 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Antimicrobial Efficacy of Synthetic Versus Herbal Intracanal Medicaments Against Enterococcus Faecalis
- ClinicalTrials.gov ID
- NCT06006663
- Acronym / sponsor ID
- eliminations of E.faecalis
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 32 participants (estimated)
- Lead sponsor
- Tanta UniversityUniversity, hospital or other
- Study start
- 26 Aug 2023 (estimated)
- Primary completion
- 5 Oct 2023 (estimated)
- Study completion
- 10 Dec 2023 (estimated)
- First posted
- 23 Aug 2023 (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 aims to evaluate the antimicrobial efficacy of two synthetic (Ibuprofen, Modified triple antibiotic paste) and two herbal materials (Curcumin and Olive leaves extract) used as intracanal medication, against E.Faecalis in secondary endodontic infection cases.
Detailed description
we evaluate the antimicrobial efficacy of two synthetic (Ibuprofen, Modified triple antibiotic paste) and two herbal materials (Curcumin and Olive leaves extract) used as intracanal medication, against E.Faecalis in secondary endodontic infection cases by taking three samples from root canal , the first sample after removing gutta percha from root canal system, the second sample after shaping with protaper universal files and cleaning with 2.5% sodium hypochlorite , the third sample after 7 days from application of the medication .
samples will be diluted into ten fold serial dilution and then the diluted samples will be cultured on bile esculin agar as it is selective media for enterococcus feacalis.
bacterial reduction will be determined and comparision will be made .
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| group 1 | Active comparator | Drug: Ibuprofen 400 mg.ibuprofen as intracanal medicament |
| group 2 | Active comparator | Drug: modified triple antibiotic pastemodified triple antibiotic paste as intracanal medicament |
| group 3 | Active comparator | Dietary Supplement: curcumincurcumin as intracanal medicament |
| group 4 | Active comparator | Dietary Supplement: olive leaves extractolive leaves as intracanal medicament |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Single rooted teeth.
- Teeth have clinical signs and symptoms of endodontic failure as sensitivity to percussion, pain, swelling or fistula.
- Teeth with radiographic features of endodontic failure as persistent periapical lesion or widening of periodontal ligament.
Key exclusion criteria (3 listed)
- • Teeth with fractures of the crown or root.
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 |
|---|---|---|
| Ibuprofen 400 mg.synthetic intracanal medicament | Drug | group 1 |
| modified triple antibiotic pasteAlso: clindamycin, ciprofloxacin and metronidazolesynthetic intracanal medicament | Drug | group 2 |
| curcuminherbal intracanal medicament | Dietary supplement | group 3 |
| olive leaves extractherbal intracanal medicament | Dietary supplement | group 4 |
Primary outcome
measurment of microbial reduction as result of applying synthetic and herbaal intracanal medicaments
Time frame: time necessary for incubation of each sample is 24 hour
sample 1 will be taken after gutta percha removal sample 2 will be taken after cleaning and shaping sample 3 will be taken after apllying the intracanal medicament for one week
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Aug 2023.
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.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Ibuprofen 400 mg., modified triple antibiotic paste and curcumin in people with Effective Intracanal Medicaments Against Enterococcus Faecalis, run by Tanta University.
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 3 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: status not confirmed, as of the sponsor's last update on 23 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact alaa essam abo laimon, demonstrator at university (01005690958, alaalamona@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
measurment of microbial reduction as result of applying synthetic and herbaal intracanal medicaments (time frame: time necessary for incubation of each sample is 24 hour). 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 23 Aug 2023.