Asymptomatic Apical PeriodontitisEarly Phase 1NCT07423663
Antimicrobial Effect of Calcium Silicate and Pectin as Intracanal Medications in Necrotic Teeth With Periapical Lesions
A Early Phase 1 study testing Calcium Hydroxide Intracanal medication, Calcium silicate based intracanal medication and Pectin in people with Asymptomatic Apical Periodontitis, run by Suez Canal University at 1 site in Egypt.
Trial summary
It is tackling antimicrobial resistance in endodontics, specifically comparing different intracanal medications used in root canal treatment. Given the growing concern over resistant bacterial strains, our study aims to evaluate the effectiveness of various medicaments in eliminating endodontic pathogens while… Read more about this study
- Who is it for?
- Ages 21 to 49 yearsHealthy volunteers can take part
- Conditions the study is for
- Asymptomatic Apical Periodontitis
- What is being tested?
- Calcium Hydroxide Intracanal medication, Calcium silicate based intracanal medication and Pectin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 63 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Sep 2024to 1 Apr 2026
- Phase
- Early Phase 1
- Are there results?
- Not yet: the study is under way
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 21 to 49 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Patients presenting with a single rooted mandibular premolar tooth with a closed apex and a single patent canal type I in Vertucci's classification (Vertucci et al., 1974).
- Having a necrotic pulp.
- A pocket depth measurement of < 3 mm.
- Teeth with no previous history of endodontic treatment.
- Teeth with periapical lesions of endodontic origin having a periapical index score of 4 or 5 (Orstavik et al., 1986)
- Patients who took antibiotics within the period of three months before the study.
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- Non-restorable teeth.
- Teeth with periodontal pockets deeper than 4mm, with or without concomitant or combined endo-perio communication
- Multirooted teeth.
- Previously initiated or treated teeth.
- Teeth with root canal calcifications or resorption.
- Teeth with internal/external root resorption or root fracture.
- Immune-compromised patients or patients with systemic diseases i.e. (diabetes mellitus, human immunodeficiency virus, leukemia, neutropenia, undergoing chemo- or systemic corticosteroid therapy)
- Teeth with root curvature of more than 15 degrees.
- Pregnant women
- Patients with known sensitivity to the medicaments used in this study.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Antimicrobial Effect of Calcium Silicate and Pectin as Intracanal Medications in Necrotic Teeth With Periapical Lesions :A Randomized Controlled Clinical Trial
It is tackling antimicrobial resistance in endodontics, specifically comparing different intracanal medications used in root canal treatment. Given the growing concern over resistant bacterial strains, our study aims to evaluate the effectiveness of various medicaments in eliminating endodontic pathogens while minimising the risk of resistance development. By integrating microbiological analysis and clinical relevance, our research seeks to provide evidence-based recommendations for optimising intracanal disinfection protocols and improving treatment outcomes in endodontic infections.
- Conditions
- Asymptomatic Apical Periodontitis
- Being tested
- Calcium Hydroxide Intracanal medication, Calcium silicate based intracanal medication, Pectin
- Keywords
- Asymptomatic Apical Periodontitis, pectin, bio-c temp, Calcium Hydroxide
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Calcium Hydroxide Intracanal medicationDrug
Patients receiving CaOH (Metapaste) intracanal medication
Calcium silicate based intracanal medicationDrug
Patients receiving Calcium silicate based (Bio-C Temp) intracanal medication
PectinDrug
Patients receiving Pectin intracanal medication
| Study group | Role | What they receive |
|---|---|---|
| Calcium Hydroxide Intracanal medication | Active comparator | Patients receiving CaOH (Metapaste) intracanal medication Receives: Drug: Calcium Hydroxide Intracanal medication |
| Calcium silicate based intracanal medication | Experimental | Patients receiving Calcium silicate based (Bio-C Temp) intracanal medication Receives: Drug: Calcium silicate based intracanal medication |
| Pectin | Experimental | Patients receiving Pectin intracanal medication Receives: Drug: Pectin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Microbiome Changes
Compare the changes in the microbial composition of the biofilm inside the infected root canal before and after chemo-mechanical preparation and before and after intracanal medicaments application using DNA next-generation sequencing.
Measured: From enrollment to the end of treatment at 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2026
- Study start1 Sep 2024
- Primary completion10 Mar 2026 (estimated)
- Study completion1 Apr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Asymptomatic Apical PeriodontitisStudies 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
- Early Phase 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 63 participants (actual)
Sponsor and investigators
- Lead sponsor
- Suez Canal University
- Sponsor type
- University, hospital or other
- Collaborators
- University of Leeds
- Responsible party
- Principal investigator, omar montassir, Suez Canal University
- Investigators
- Omar Montaser, M.D.Sc, Principal investigator, Suez Canal University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07423663
- Sponsor's protocol ID
- 645/2023
- Status last verified
- Feb 2026
- First submitted
- 5 Jun 2025
- Last updated
- 20 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Antimicrobial Effect of Calcium Silicate and Pectin as Intracanal Medications in Necrotic Teeth With Periapical Lesions :A Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT07423663
- Acronym / sponsor ID
- 645/2023
- Conditions
- Asymptomatic Apical Periodontitis
- Keywords
- Asymptomatic Apical Periodontitis, pectin, bio-c temp, Calcium Hydroxide
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 63 participants (actual)
- Lead sponsor
- Suez Canal UniversityUniversity, hospital or other
- Collaborators
- University of Leeds
- Study start
- 1 Sep 2024 (actual)
- Primary completion
- 10 Mar 2026 (estimated)
- Study completion
- 1 Apr 2026 (estimated)
- First posted
- 20 Feb 2026 (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.
It is tackling antimicrobial resistance in endodontics, specifically comparing different intracanal medications used in root canal treatment. Given the growing concern over resistant bacterial strains, our study aims to evaluate the effectiveness of various medicaments in eliminating endodontic pathogens while minimising the risk of resistance development. By integrating microbiological analysis and clinical relevance, our research seeks to provide evidence-based recommendations for optimising intracanal disinfection protocols and improving treatment outcomes in endodontic infections.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Calcium Hydroxide Intracanal medication | Active comparator | Drug: Calcium Hydroxide Intracanal medicationPatients receiving CaOH (Metapaste) intracanal medication |
| Calcium silicate based intracanal medication | Experimental | Drug: Calcium silicate based intracanal medicationPatients receiving Calcium silicate based (Bio-C Temp) intracanal medication |
| Pectin | Experimental | Drug: PectinPatients receiving Pectin intracanal medication |
Who may qualify
- Ages
- 21 to 49 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (16 listed)
- Patients presenting with a single rooted mandibular premolar tooth with a closed apex and a single patent canal type I in Vertucci's classification (Vertucci et al., 1974).
- Having a necrotic pulp.
- A pocket depth measurement of < 3 mm.
- Teeth with no previous history of endodontic treatment.
- Teeth with periapical lesions of endodontic origin having a periapical index score of 4 or 5 (Orstavik et al., 1986)
Key exclusion criteria (0 listed)
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 medicationPatients receiving CaOH (Metapaste) intracanal medication | Drug | Calcium Hydroxide Intracanal medication |
| Calcium silicate based intracanal medicationPatients receiving Calcium silicate based (Bio-C Temp) intracanal medication | Drug | Calcium silicate based intracanal medication |
| PectinPatients receiving Pectin intracanal medication | Drug | Pectin |
Primary outcome
Microbiome Changes
Time frame: From enrollment to the end of treatment at 2 weeks
Compare the changes in the microbial composition of the biofilm inside the infected root canal before and after chemo-mechanical preparation and before and after intracanal medicaments application using DNA next-generation sequencing.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2026.
- Individual participant dataSharing planned: Undecided
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Postoperative Pain and Success of Single-Visit Root Canal Treatment Using Different Root Canal Sealers in Asymptomatic Teeth
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Effects of Intracanal Cryotherapy on Biomarkers and Postoperative Pain in Apical Periodontitis
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Sonic Irrigation Activation for Postoperative Pain After Root Canal Treatment
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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.
Omar Montaser, M.D.Sc principal investigator
Suez Canal University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Calcium Hydroxide Intracanal medication, Calcium silicate based intracanal medication and Pectin in people with Asymptomatic Apical Periodontitis, 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 16 inclusion and 0 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: under way, not looking for participants, as of the sponsor's last update on 20 Feb 2026. 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 phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
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?
Microbiome Changes (time frame: From enrollment to the end of treatment at 2 weeks). 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 Feb 2026.