Intracanal MedicationPhase 2/3NCT06566508
Effectiveness of Asiaticoside as Intracanal Medication on Infectious/Inflammatory Contents in Teeth With Apical Periodontitis
A Phase 2/3 study testing Calcium Hydroxide Intracanal medication, Leddermix Intracanal medication and Asiaticoside Intracanal medication in people with Intracanal Medication, run by Mansoura University at 1 site in Egypt.
Trial summary
The objective of this study is to investigate \"clinically\" the effectiveness of Asiaticoside based intracanal medication compared to the commonly used intracanal medicaments (calcium hydroxide Ca(OH)2 and Ledermix) on the levels of bacteria and inflammatory cytokines in root canals and periradicular tissues… Read more about this study
- Who is it for?
- Ages 20 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Intracanal Medication
- What is being tested?
- Calcium Hydroxide Intracanal medication, Leddermix Intracanal medication and Asiaticoside Intracanal medication
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteEgypt
- Study dates
- 20 Nov 2023to 3 Mar 2025
- 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 20 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Single-rooted with pulp necrosis and apical periodontitis.
Who cannot join
- Receiving antibiotic treatment within the preceding 3 months.
- Reporting systemic disease.
- Teeth that could not be isolated with rubber dam.
- Teeth with periodontal pockets deeper than 3 mm.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Mansoura university
Al Mansurah
salem alqahtani, master, 00201553553096, salemamq@gmail.com
khalid aldhafeeri, master, 00966532966229, van.gool17@hotmail.com
About this study
The objective of this study is to investigate \"clinically\" the effectiveness of Asiaticoside based intracanal medication compared to the commonly used intracanal medicaments (calcium hydroxide Ca(OH)2 and Ledermix) on the levels of bacteria and inflammatory cytokines in root canals and periradicular tissues of teeth with apical periodontitis.
Read the detailed description
This study investigate \"clinically\" the effectiveness of Asiaticoside based intracanal medication compared to the commonly used intracanal medicaments (calcium hydroxide Ca(OH)2 and Ledermix) on the levels of bacteria and inflammatory cytokines in root canals and periradicular tissues of teeth with apical periodontitis.
- Conditions
- Intracanal Medication
- Being tested
- Calcium Hydroxide Intracanal medication, Leddermix Intracanal medication, Asiaticoside Intracanal medication
- Keywords
- Inflammation, Asiaticoside, Pulpal necrosis
- Medical subject headings
- Inflammation, Dental Pulp Necrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Calcium Hydroxide Intracanal medicationDrug
Calcium Hydroxide Intracanal medication
Leddermix Intracanal medicationDrug
Leddermix Intracanal medication
Asiaticoside Intracanal medicationDrug
Also called centella asiatica
Asiaticoside Intracanal medication
| Study group | Role | What they receive |
|---|---|---|
| Calcium Hydroxide | Active comparator | Intracanal medication Receives: Drug: Calcium Hydroxide Intracanal medication |
| Leddermix | Active comparator | Intracanal medication Receives: Drug: Leddermix Intracanal medication |
| Asiaticoside | Active comparator | Intracanal medication Receives: Drug: Asiaticoside Intracanal medication |
What is being measured
The primary outcome is the main question the study is designed to answer.
counting the number of colonies forming units of bacterial cells Microbiology cell culturing (manual counting technique to the bacterial cells) [Time Frame: up to 7 months]
counting the number of colonies forming units of bacterial cells Microbiology cell culturing (manual counting technique to the bacterial cells) [Time Frame: up to 7 months]
Measured: up to 7 months
Secondary outcomes (1)
using enzyme-linked immunosorbent assay (ELISA test) to measure the amount of Inflammatory Cytokines (TNF-α), (IL-1β) and (PG2) ELISA test to measure the amount of tumor necrotizing factor (TNF-α), interleukin 1β(IL-1β) and prostaglandin E2 (PG2)
using enzyme-linked immunosorbent assay (ELISA test) to measure the amount of Inflammatory Cytokines (TNF-α), (IL-1β) and (PG2) ELISA test to measure the amount of tumor necrotizing factor (TNF-α), interleukin 1β(IL-1β) and prostaglandin E2 (PG2)
Measured: up to 25 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2024
- Study start20 Nov 2023
- Primary completion5 Jun 2024
- Study completion3 Mar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intracanal MedicationStudies of the same condition, open and under way.
- More trials run by Mansoura 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
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Salem Abdulrahman Alqahtani, Mansoura University
- Investigators
- Amany Bader, prof, Study director, Faculty of Dentistry Mansoura UniversityYoussry Elhawary, prof, Study director, Faculty of Dentistry Mansoura University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06566508
- Sponsor's protocol ID
- A0209023RC
- Status last verified
- Aug 2024
- First submitted
- 20 Aug 2024
- Last updated
- 22 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Asiaticoside as Intracanal Medication on Infectious/Inflammatory Contents in Teeth With Apical Periodontitis
- ClinicalTrials.gov ID
- NCT06566508
- Acronym / sponsor ID
- A0209023RC
- Conditions
- Intracanal Medication
- Keywords
- Inflammation, Asiaticoside, Pulpal necrosis
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- 20 Nov 2023 (actual)
- Primary completion
- 5 Jun 2024 (actual)
- Study completion
- 3 Mar 2025 (estimated)
- First posted
- 22 Aug 2024 (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.
The objective of this study is to investigate \"clinically\" the effectiveness of Asiaticoside based intracanal medication compared to the commonly used intracanal medicaments (calcium hydroxide Ca(OH)2 and Ledermix) on the levels of bacteria and inflammatory cytokines in root canals and periradicular tissues of teeth with apical periodontitis.
Detailed description
This study investigate \"clinically\" the effectiveness of Asiaticoside based intracanal medication compared to the commonly used intracanal medicaments (calcium hydroxide Ca(OH)2 and Ledermix) on the levels of bacteria and inflammatory cytokines in root canals and periradicular tissues of teeth with apical periodontitis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Calcium Hydroxide | Active comparator | Drug: Calcium Hydroxide Intracanal medicationIntracanal medication |
| Leddermix | Active comparator | Drug: Leddermix Intracanal medicationIntracanal medication |
| Asiaticoside | Active comparator | Drug: Asiaticoside Intracanal medicationIntracanal medication |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Single-rooted with pulp necrosis and apical periodontitis.
Key exclusion criteria (4 listed)
- Receiving antibiotic treatment within the preceding 3 months.
- Reporting systemic disease.
- Teeth that could not be isolated with rubber dam.
- Teeth with periodontal pockets deeper than 3 mm.
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 |
|---|---|---|
| Calcium Hydroxide Intracanal medicationCalcium Hydroxide Intracanal medication | Drug | Calcium Hydroxide |
| Leddermix Intracanal medicationLeddermix Intracanal medication | Drug | Leddermix |
| Asiaticoside Intracanal medicationAlso: centella asiaticaAsiaticoside Intracanal medication | Drug | Asiaticoside |
Primary outcome
counting the number of colonies forming units of bacterial cells Microbiology cell culturing (manual counting technique to the bacterial cells) [Time Frame: up to 7 months]
Time frame: up to 7 months
counting the number of colonies forming units of bacterial cells Microbiology cell culturing (manual counting technique to the bacterial cells) [Time Frame: up to 7 months]
1 secondary outcome
using enzyme-linked immunosorbent assay (ELISA test) to measure the amount of Inflammatory Cytokines (TNF-α), (IL-1β) and (PG2) ELISA test to measure the amount of tumor necrotizing factor (TNF-α), interleukin 1β(IL-1β) and prostaglandin E2 (PG2)
Time frame: up to 25 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Aug 2024.
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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.
Amany Bader, prof study director
Faculty of Dentistry Mansoura University
Youssry Elhawary, prof study director
Faculty of Dentistry Mansoura University
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 Calcium Hydroxide Intracanal medication, Leddermix Intracanal medication and Asiaticoside Intracanal medication in people with Intracanal Medication, run by Mansoura 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 1 inclusion and 4 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 22 Aug 2024. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact salem alqahtani, master (00201553553096, Salemamq@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
counting the number of colonies forming units of bacterial cells Microbiology cell culturing (manual counting technique to the bacterial cells) [Time Frame: up to 7 months] (time frame: up to 7 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 22 Aug 2024.