Intervention StudiesPhase 1RCTNCT07641933
Biological, Radiographic and Clinical Evaluation of Various Inter-Visit Root Canal Dressings in Retreatment Cases
A Phase 1 study testing Calcium Silicate Intracanal Medication, Calcium Hydroxide Slurry mixed with Sodium Hypochlorite Intracanal Medication and Calcium Hydroxide (Ca(OH)2) Intracanal Medication in people with Intervention Studies and ASA Physical Status I, run by Ain Shams University at 1 site in Egypt.
Trial summary
The aim of this clinical trial is to evaluate anti-inflammatory effect of various intracanal medications: 1. Calcium Hydroxide Slurry mixed with 3% Sodium Hypochlorite 2. Calcium Silicate 3. Calcium Hydroxide In retreatment cases in terms of: 1. Biological Evaluation: Biomarker (IL 1B) 2. Read more about this study
- Who is it for?
- Ages 21 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Intervention Studies, ASA Physical Status I, Intracanal Medication
- What is being tested?
- Calcium Silicate Intracanal Medication, Calcium Hydroxide Slurry mixed with Sodium Hypochlorite Intracanal Medication and Calcium Hydroxide (Ca(OH)2) Intracanal Medication
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jun 2026to Aug 2027
- Phase
- 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 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age: 21-45 years.
- Medically free patients. (ASA Class 1)
- Gender: males and females
- Patients who are cooperative at operation and in attendance at scheduled follow-up visits.
- Restorable root canal treated permanent lower first molars with periapical lesions.
- Small (<5 mm) or medium periapical lesion size (5-10 mm)
Who cannot join
- Patients with a history of allergic reactions to any of the study materials.
- Teeth that become non-restorable after complete caries excavation.
- Teeth that have mobility or deep periodontal pockets.
- Teeth with internal or external resorption.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site, 1 recruiting
- Recruiting
Ain Shams University
Cairo
Ain Shams University, 00201000397491
About this study
Official title: Biological, Radiographic and Clinical Evaluation of Various Inter-Visit Root Canal Dressings in Retreatment Cases: A Randomized Controlled Clinical Trial
The aim of this clinical trial is to evaluate anti-inflammatory effect of various intracanal medications:
- Calcium Hydroxide Slurry mixed with 3% Sodium Hypochlorite
- Calcium Silicate
- Calcium Hydroxide
In retreatment cases in terms of:
- Biological Evaluation: Biomarker (IL 1B)
- Radiographic Evaluation: CBCT
- Clinical Evaluation: Pain Score (VAS)
Read the detailed description
Sixty patients presenting with failed root canal treated lower first molars with periapical lesion were included in this randomized controlled single-center clinical superiority trial with two parallel arms and randomly allocated to 3 equal groups (n = 20) according to the type of ICM used. Patients were randomly allocated to receive either Ca(OH)2 slurry that was prepared from pure Ca(OH)2 powder mixed with 3% NaOCl, calcium-silicate (Bio-C Temp) or calcium hydroxide (CH) as ICM. Teeth were instrumented using a rotary file system (M3 pro Gold) and irrigated with 3% NaOCl. Subsequently, the root canals were dressed with a Ca(OH)2 + NaOCl or calcium silicate (test groups) or Ca(OH)2 (control group). Periapical fluid samples were collected after accessing the root canal in the first visit and after the root canal dressing removal in the second visit 2 weeks later using paper point. Samples were transferred to the microbiology lab immediately and levels of pro-inflammatory marker (IL1B) were measured using a specific enzyme-linked immunosorbent assay (ELISA) immediately after the second visit to test the reduction in inflammatory marker level after intracanal medication usage. Also, preoperative and 12 months-postoperative radiographic evaluation by CBCT were obtained to measure volumetric reduction in lesion size using segmentation technique. And patients rated their pain pre-operatively and then after 6, 12, 24, 48, 72 h and 7 days using the VAS score. Clinical and radiographic follow-up evaluations were scheduled for 1 week, 1 month, 6 months and 12 months by examining the patient clinically using palpation and percussion tests and pain questionnaire and periapical digital radiographs to compare reduction in lesion size.
- Conditions
- Intervention Studies, ASA Physical Status I, Intracanal Medication, Periapical Abscess, Retreatment
- Being tested
- Calcium Silicate Intracanal Medication, Calcium Hydroxide Slurry mixed with Sodium Hypochlorite Intracanal Medication, Calcium Hydroxide (Ca(OH)2) Intracanal Medication
- Keywords
- intracanal medication, retreatment, inflammatory marker, radiographic, pain score
- Medical subject headings
- Periapical Abscess
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Calcium Silicate Intracanal MedicationDrug
Calcium silicate-based bioceramic materials have gained attention for their bioactivity and biocompatibility, acting through hydration with calcium hydroxide release followed by hydroxyapatite formation that promotes healing. Bio-C Temp is an example, characterized by high calcium ion release, alkaline pH, adequate radiopacity, and good biocompatibility.
Calcium Hydroxide Slurry mixed with Sodium Hypochlorite Intracanal MedicationDrug
Combining calcium hydroxide with sodium hypochlorite (NaOCl) has been proposed. NaOCl provides rapid and potent antimicrobial and tissue-dissolving effects, while Ca(OH)₂ offers prolonged action. Both agents retain their properties when combined, and this combination may produce a synergistic effect that enhances disinfection and reduces chair time in two-visit treatment protocols.
Calcium Hydroxide (Ca(OH)2) Intracanal MedicationDrug
Calcium hydroxide ICM being the most widely used due to its high alkalinity, antimicrobial properties, endotoxin neutralization, and ability to reduce periapical inflammation. It is applied as an aqueous mixture or polyethylene glycol-based paste and provides a slow but sustained antimicrobial effect. Despite their benefits, Ca(OH)₂ medicaments re limited by their solubility, susceptibility to tissue fluids, potential to weaken tooth structure over time, and reduced effectiveness against resistant microorganisms such as Candida Albicans and Enterococcus Faecalis.
| Study group | Role | What they receive |
|---|---|---|
| Calcium Silicate Intracanal Medication | Experimental | Calcium silicate-based bioceramic Intracanal Medication as Bio C-Temp (Angelus) Receives: Drug: Calcium Silicate Intracanal Medication |
| Calcium Hydroxide Slurry mixed with Sodium Hypochlorite | Experimental | Calcium Hydroxide slurry mixed with 3% Sodium Hypochlorite Receives: Drug: Calcium Hydroxide Slurry mixed with Sodium Hypochlorite Intracanal Medication |
| Calcium Hydroxide | Active comparator | Calcium Hydroxide Intracanal Medication (Control Group) Receives: Drug: Calcium Hydroxide (Ca(OH)2) Intracanal Medication |
What is being measured
The primary outcome is the main question the study is designed to answer.
Biological Evaluation of inflammatory marker (IL-1B)
IL-1B collected by periapical fluid sample using paper points and measured using ELISA.
Measured: 1st sample is collected in the first visit after root canal filling removal while 2nd sample is collected after intracanal medication removal in the second visit. Both visits are 14 days apart.
Secondary outcomes (1)
Radiographic Evaluation using limited FOV CBCT
Pre-operative and post-operative limited FOV CBCT scans are taken to compare volumetric reduction in periapical lesion size.
Measured: 1 year between pre- and post-operative CBCT scans.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2026
- Study start1 Jun 2026
- Primary completionJun 2027 (estimated)
- Study completionAug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intervention StudiesStudies of the same condition, open and under way.
- More trials run by Ain Shams 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Intracanal medication (drug) approved by the FDA.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07641933
- Sponsor's protocol ID
- 1740
- Acronym
- RCT
- Status last verified
- Jun 2026
- First submitted
- 7 Jun 2026
- Last updated
- 12 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- 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 12 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Biological, Radiographic and Clinical Evaluation of Various Inter-Visit Root Canal Dressings in Retreatment Cases: A Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT07641933
- Acronym / sponsor ID
- RCT / 1740
- Conditions
- Intervention Studies, ASA Physical Status I, Intracanal Medication, Periapical Abscess, Retreatment
- Keywords
- intracanal medication, retreatment, inflammatory marker, radiographic, pain score
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 1 Jun 2026 (actual)
- Primary completion
- Jun 2027 (estimated)
- Study completion
- Aug 2027 (estimated)
- First posted
- 11 Jun 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.
The aim of this clinical trial is to evaluate anti-inflammatory effect of various intracanal medications:
- Calcium Hydroxide Slurry mixed with 3% Sodium Hypochlorite
- Calcium Silicate
- Calcium Hydroxide
In retreatment cases in terms of:
- Biological Evaluation: Biomarker (IL 1B)
- Radiographic Evaluation: CBCT
- Clinical Evaluation: Pain Score (VAS)
Detailed description
Sixty patients presenting with failed root canal treated lower first molars with periapical lesion were included in this randomized controlled single-center clinical superiority trial with two parallel arms and randomly allocated to 3 equal groups (n = 20) according to the type of ICM used. Patients were randomly allocated to receive either Ca(OH)2 slurry that was prepared from pure Ca(OH)2 powder mixed with 3% NaOCl, calcium-silicate (Bio-C Temp) or calcium hydroxide (CH) as ICM. Teeth were instrumented using a rotary file system (M3 pro Gold) and irrigated with 3% NaOCl. Subsequently, the root canals were dressed with a Ca(OH)2 + NaOCl or calcium silicate (test groups) or Ca(OH)2 (control group). Periapical fluid samples were collected after accessing the root canal in the first visit and after the root canal dressing removal in the second visit 2 weeks later using paper point. Samples were transferred to the microbiology lab immediately and levels of pro-inflammatory marker (IL1B) were measured using a specific enzyme-linked immunosorbent assay (ELISA) immediately after the second visit to test the reduction in inflammatory marker level after intracanal medication usage. Also, preoperative and 12 months-postoperative radiographic evaluation by CBCT were obtained to measure volumetric reduction in lesion size using segmentation technique. And patients rated their pain pre-operatively and then after 6, 12, 24, 48, 72 h and 7 days using the VAS score. Clinical and radiographic follow-up evaluations were scheduled for 1 week, 1 month, 6 months and 12 months by examining the patient clinically using palpation and percussion tests and pain questionnaire and periapical digital radiographs to compare reduction in lesion size.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
- Model description
- Intracanal medication (drug) approved by the FDA.
| Arm | Type | Receives |
|---|---|---|
| Calcium Silicate Intracanal Medication | Experimental | Drug: Calcium Silicate Intracanal MedicationCalcium silicate-based bioceramic Intracanal Medication as Bio C-Temp (Angelus) |
| Calcium Hydroxide Slurry mixed with Sodium Hypochlorite | Experimental | Drug: Calcium Hydroxide Slurry mixed with Sodium Hypochlorite Intracanal MedicationCalcium Hydroxide slurry mixed with 3% Sodium Hypochlorite |
| Calcium Hydroxide | Active comparator | Drug: Calcium Hydroxide (Ca(OH)2) Intracanal MedicationCalcium Hydroxide Intracanal Medication (Control Group) |
Who may qualify
- Ages
- 21 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Age: 21-45 years.
- Medically free patients. (ASA Class 1)
- Gender: males and females
- Patients who are cooperative at operation and in attendance at scheduled follow-up visits.
- Restorable root canal treated permanent lower first molars with periapical lesions.
Key exclusion criteria (4 listed)
- Patients with a history of allergic reactions to any of the study materials.
- Teeth that become non-restorable after complete caries excavation.
- Teeth that have mobility or deep periodontal pockets.
- Teeth with internal or external resorption.
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 Silicate Intracanal MedicationCalcium silicate-based bioceramic materials have gained attention for their bioactivity and biocompatibility, acting through hydration with calcium hydroxide release followed by hydroxyapatite formation that promotes healing. Bio-C Temp is an example, characterized by high calcium ion release, alkaline pH, adequate radiopacity, and good biocompatibility. | Drug | Calcium Silicate Intracanal Medication |
| Calcium Hydroxide Slurry mixed with Sodium Hypochlorite Intracanal MedicationCombining calcium hydroxide with sodium hypochlorite (NaOCl) has been proposed. NaOCl provides rapid and potent antimicrobial and tissue-dissolving effects, while Ca(OH)₂ offers prolonged action. Both agents retain their properties when combined, and this combination may produce a synergistic effect that enhances disinfection and reduces chair time in two-visit treatment protocols. | Drug | Calcium Hydroxide Slurry mixed with Sodium Hypochlorite |
| Calcium Hydroxide (Ca(OH)2) Intracanal MedicationCalcium hydroxide ICM being the most widely used due to its high alkalinity, antimicrobial properties, endotoxin neutralization, and ability to reduce periapical inflammation. It is applied as an aqueous mixture or polyethylene glycol-based paste and provides a slow but sustained antimicrobial effect. Despite their benefits, Ca(OH)₂ medicaments re limited by their solubility, susceptibility to tissue fluids, potential to weaken tooth structure over time, and reduced effectiveness against resistant microorganisms such as Candida Albicans and Enterococcus Faecalis. | Drug | Calcium Hydroxide |
Primary outcome
Biological Evaluation of inflammatory marker (IL-1B)
Time frame: 1st sample is collected in the first visit after root canal filling removal while 2nd sample is collected after intracanal medication removal in the second visit. Both visits are 14 days apart.
IL-1B collected by periapical fluid sample using paper points and measured using ELISA.
1 secondary outcome
Radiographic Evaluation using limited FOV CBCT
Time frame: 1 year between pre- and post-operative CBCT scans.
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 12 Jun 2026.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Calcium Silicate Intracanal Medication, Calcium Hydroxide Slurry mixed with Sodium Hypochlorite Intracanal Medication and Calcium Hydroxide (Ca(OH)2) Intracanal Medication in people with Intervention Studies and ASA Physical Status I, run by Ain Shams 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 6 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: looking for participants now, as of the sponsor's last update on 12 Jun 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?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Contact Merna Mamdouh Botros Billatos, Msc (00201201579537, mernabotros@dent.asu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Biological Evaluation of inflammatory marker (IL-1B) (time frame: 1st sample is collected in the first visit after root canal filling removal while 2nd sample is collected after intracanal medication removal in the second visit. Both visits are 14 days apart.). 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 12 Jun 2026.