Microbial ColonizationPhase 2/3NCT06466538
Investigate"Clinically" the Effectiveness of Boswellia Based Intracanal Medication Compared to 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
A Phase 2/3 study testing Calcium hydroxide, Leddermix and Boswellia in people with Microbial Colonization, run by Mansoura University at 1 site in Egypt.
Trial summary
The objective of this study is to investigate "clinically" the effectiveness of Boswellia 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… Read more about this study
- Who is it for?
- Ages 20 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Microbial Colonization
- What is being tested?
- Calcium hydroxide, Leddermix and Boswellia
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jun 2022to 20 Jul 2024
- 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.
- The age range from 20 to 60 years
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
May Abuzoor
Al Mansurah
May Abuzoor, phD, 0096599182767, drmayzoor@hotmail.com
About this study
Official title: Effectiveness of Boswellia as Intracanal Medication on Infectious/Inflammatory Contents in Teeth With Apical Periodontitis
The objective of this study is to investigate "clinically" the effectiveness of Boswellia 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
Apical periodontitis is an inflammatory disorder of the periradicular tissue caused by bacterial infection of endodontic origin, which is characterized by periapical bone resorption. Primary endodontic disease has a polymicrobial etiology, with predominance of Gram-negative anaerobic bacteria. This species presents lipopolysaccharides (LPSs), one of the most important inflammatory molecules present in the outer layer of its membrane, which can be released during multiplication or bacterial death, thus continuously stimulating the surrounding tissues even at low levels.
Endotoxins have been detected in 100% of the primarily infected root canals, with high levels being related to more severe inflammatory response in periapical tissues. When bacteria and their toxins (e.g., LPS) present in the root canal infection egress into the periapical tissues via apical foramen, they activate immune response locally, culminating in a very complex inflammatory disorder involving a variety of inflammatory cells as well as different proinflammatory cytokines. IL-1β, TNF-α, and PGE2 have been detected in periapical tissues, being considered important inflammatory biomarkers in the apical disease. Since bacteria and their by-products are one of the main causes of apical periodontitis, special emphasis is given to the search for an optimal root canal disinfection protocol.
Although instrumentation may be assumed to be of greater importance in the clinical practice, the use of intracanal medication has been proven to optimize the root canal disinfection. For this reason, a wide variety of intracanal medications have been proposed. Calcium hydroxide [Ca(OH)2] is the most commonly used intracanal medication. Lately, chlorhexidine (CHX) has emerged as a potential intracanal medication and suggested to be used alone or combined with Ca(OH)2 in a paste. Although studies have investigated the antibacterial property of Ca(OH)2, including CHX associations, the effects on immune periapical response is incipient.
Another effective intracanal medication is Ledermix which contains 1% triamcinolone (TAA) and 3% demeclocycline (DOC). This formulation was first recommended for use in endodontics. The use of Ledermix appear to be more likely related to the anti-inflammatory effects of corticosteroid rather than its antibacterial effect .The antibiotic component does not appear to be ideal, and the use of other antibiotics may help to improve the antimicrobial effects of Ledermix.
Because root canal medicaments can come in contact with periapical tissue, in addition to having good antibacterial ability, they must also be biocompatible. In selecting root canal medicaments, it is necessary to consider their therapeutic benefits against their potential cytotoxic effects. Ideal root canal medicaments should have strong antibacterial properties and minimal cytotoxic effect on the host tissues. Herbs have been used in clinical medicine for thousands of years. However, it is only in recent times that researchers have been able to employ scientific methods to prove the efficacy of many of these herbs and to provide a better understanding of their mechanisms of action (Graf 2000).
Ayurveda (Indian traditional medicine practice) used Boswellia for the treatment of gastrointestinal diseases such as diarrhea, constipation, flatulence and vomiting. It was also stated that the extract is useful in the treatment for diabetic patients and also for respiratory complications including cough, cold, hoarseness, bronchitis, asthma and dyspnea.
So based on the above mentioned data, it is believed to be of interest to investigate clinically the use of Boswellia as an intracanal medication.
- Conditions
- Microbial Colonization
- Being tested
- Calcium hydroxide, Leddermix, Boswellia
- Medical subject headings
- Communicable Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Calcium hydroxideDrug
intracanal medicament
LeddermixDrug
Leddermix
BoswelliaDrug
Boswellia
| Study group | Role | What they receive |
|---|---|---|
| Calcium Hydroxide | Active comparator | intracanal medicament Receives: Drug: Calcium hydroxide |
| Leddermix | Active comparator | intracanal medicament Receives: Drug: Leddermix |
| Boswellia | Active comparator | intracanal medicament Receives: Drug: Boswellia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Microbiological culture (manual counting to bacterial cells)
Bacterial counting after culturing of bacteria
Measured: up to 8 months
Secondary outcomes (1)
ELISA test to measure levels of Inflammatory cytokines (tumor necrotizing factor, prostaglandin E2, Interleukin 1B)
ELISA test to measure levels of Inflammatory cytokines (tumor necrotizing factor, prostaglandin E2, Interleukin 1B)
Measured: 30 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jun 2024
- Study start1 Jun 2022
- Primary completion1 Jul 2024 (estimated)
- Study completion20 Jul 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Microbial ColonizationStudies 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
- Sponsor
- Investigators
- Amany Badr, Professor, Study chair, Mansoura UniversityYoussry RM Elhawary, Professor, Study director, Mansoura University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06466538
- Sponsor's protocol ID
- Root Canal Medicament
- Status last verified
- Jun 2024
- First submitted
- 8 Jun 2024
- Last updated
- 20 Jun 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Khosravi Samani M, Mahmoodian H, Moghadamnia A, Poorsattar Bejeh Mir A, Chitsazan M. The effect of Frankincense in the treatment of moderate plaque-induced gingivitis: a double blinded randomized clinical trial. Daru. 2011;19(4):288-94.
PubMed 22615671Raja AF, Ali F, Khan IA, Shawl AS, Arora DS, Shah BA, Taneja SC. Antistaphylococcal and biofilm inhibitory activities of acetyl-11-keto-beta-boswellic acid from Boswellia serrata. BMC Microbiol. 2011 Mar 16;11:54. doi: 10.1186/1471-2180-11-54.
PubMed 21406118
Study at a glance
From the registry record, last updated by the sponsor on 20 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Boswellia as Intracanal Medication on Infectious/Inflammatory Contents in Teeth With Apical Periodontitis
- ClinicalTrials.gov ID
- NCT06466538
- Acronym / sponsor ID
- Root Canal Medicament
- Conditions
- Microbial Colonization
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- 1 Jun 2022 (actual)
- Primary completion
- 1 Jul 2024 (estimated)
- Study completion
- 20 Jul 2024 (estimated)
- First posted
- 20 Jun 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 Boswellia 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
Apical periodontitis is an inflammatory disorder of the periradicular tissue caused by bacterial infection of endodontic origin, which is characterized by periapical bone resorption. Primary endodontic disease has a polymicrobial etiology, with predominance of Gram-negative anaerobic bacteria. This species presents lipopolysaccharides (LPSs), one of the most important inflammatory molecules present in the outer layer of its membrane, which can be released during multiplication or bacterial death, thus continuously stimulating the surrounding tissues even at low levels.
Endotoxins have been detected in 100% of the primarily infected root canals, with high levels being related to more severe inflammatory response in periapical tissues. When bacteria and their toxins (e.g., LPS) present in the root canal infection egress into the periapical tissues via apical foramen, they activate immune response locally, culminating in a very complex inflammatory disorder involving a variety of inflammatory cells as well as different proinflammatory cytokines. IL-1β, TNF-α, and PGE2 have been detected in periapical tissues, being considered important inflammatory biomarkers in the apical disease. Since bacteria and their by-products are one of the main causes of apical periodontitis, special emphasis is given to the search for an optimal root canal disinfection protocol.
Although instrumentation may be assumed to be of greater importance in the clinical practice, the use of intracanal medication has been proven to optimize the root canal disinfection. For this reason, a wide variety of intracanal medications have been proposed. Calcium hydroxide [Ca(OH)2] is the most commonly used intracanal medication. Lately, chlorhexidine (CHX) has emerged as a potential intracanal medication and suggested to be used alone or combined with Ca(OH)2 in a paste. Although studies have investigated the antibacterial property of Ca(OH)2, including CHX associations, the effects on immune periapical response is incipient.
Another effective intracanal medication is Ledermix which contains 1% triamcinolone (TAA) and 3% demeclocycline (DOC). This formulation was first recommended for use in endodontics. The use of Ledermix appear to be more likely related to the anti-inflammatory effects of corticosteroid rather than its antibacterial effect .The antibiotic component does not appear to be ideal, and the use of other antibiotics may help to improve the antimicrobial effects of Ledermix.
Because root canal medicaments can come in contact with periapical tissue, in addition to having good antibacterial ability, they must also be biocompatible. In selecting root canal medicaments, it is necessary to consider their therapeutic benefits against their potential cytotoxic effects. Ideal root canal medicaments should have strong antibacterial properties and minimal cytotoxic effect on the host tissues. Herbs have been used in clinical medicine for thousands of years. However, it is only in recent times that researchers have been able to employ scientific methods to prove the efficacy of many of these herbs and to provide a better understanding of their mechanisms of action (Graf 2000).
Ayurveda (Indian traditional medicine practice) used Boswellia for the treatment of gastrointestinal diseases such as diarrhea, constipation, flatulence and vomiting. It was also stated that the extract is useful in the treatment for diabetic patients and also for respiratory complications including cough, cold, hoarseness, bronchitis, asthma and dyspnea.
So based on the above mentioned data, it is believed to be of interest to investigate clinically the use of Boswellia as an intracanal medication.
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 hydroxideintracanal medicament |
| Leddermix | Active comparator | Drug: Leddermixintracanal medicament |
| Boswellia | Active comparator | Drug: Boswelliaintracanal medicament |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Single-rooted with pulp necrosis and apical periodontitis.
- The age range from 20 to 60 years
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 hydroxideintracanal medicament | Drug | Calcium Hydroxide |
| LeddermixLeddermix | Drug | Leddermix |
| BoswelliaBoswellia | Drug | Boswellia |
Primary outcome
Microbiological culture (manual counting to bacterial cells)
Time frame: up to 8 months
Bacterial counting after culturing of bacteria
1 secondary outcome
ELISA test to measure levels of Inflammatory cytokines (tumor necrotizing factor, prostaglandin E2, Interleukin 1B)
Time frame: 30 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jun 2024.
- Background: PubMed 22615671Khosravi Samani M, Mahmoodian H, Moghadamnia A, Poorsattar Bejeh Mir A, Chitsazan M. The effect of Frankincense in the treatment of moderate plaque-induced gingivitis: a double blinded randomized clinical trial. Daru. 2011;19(4):288-94.
- Background: PubMed 21406118Raja AF, Ali F, Khan IA, Shawl AS, Arora DS, Shah BA, Taneja SC. Antistaphylococcal and biofilm inhibitory activities of acetyl-11-keto-beta-boswellic acid from Boswellia serrata. BMC Microbiol. 2011 Mar 16;11:54. doi: 10.1186/1471-2180-11-54.
Related trials for Microbial Colonization
RecruitingPhase 1
Restoration of the Gut Microbiome After Cesarean Section
Microbial Colonization
Recruiting
The Genital Microbiome of Male Partners of Women With Recurrent BV Undergoing Vaginal Microbiome Transplantation
Bacterial Vaginosis, Microbial Colonization
Active, not recruiting
Early Protein Supplementation in Extremely Preterm Infants Fed Human Milk
Prematurity; Extreme, Feeding Disorder Neonatal
RecruitingObservational study
Understanding the Burn Wound Microbiome: Comparing Traditional Wound Cultures to Next Generation Sequencing Technology
Microbial Colonization, Burns
Recruiting
Microbial Evaluation of MK1 and Clip Attachments in Implant Overdentures
Evaluation of Microbial Colonization Around Implants and Overdenture Surfaces Using MK1 and Clip Attachments
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 Badr, Professor study chair
Mansoura University
Youssry RM Elhawary, Professor study director
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, Leddermix and Boswellia in people with Microbial Colonization, 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 2 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 20 Jun 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 May Abuzoor, phD (0096599182767, drmayzoor@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Microbiological culture (manual counting to bacterial cells) (time frame: up to 8 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06466538, which also lists 2 linked publications.
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 Jun 2024; AzTrials last refreshed its copy on 7 Nov 2026.