Intracanal DressingEarly Phase 1NCT07101029
Effect of Bio-C Temp Versus Calcium Ydroxide as Intracanal Dressings on Postoperative Pain Intensity and Periapical MMP-9 Level in Patients With Necrotic Pulp
A Early Phase 1 study testing Bio-C Temp Intracanal Medication and Calcium Hydroxide Intracanal medication in people with Intracanal Dressing and Apical Periodontitis, run by Cairo University.
Trial summary
To compare the effect of Bio-C Temp Bioceramic intracanal dressing versus calcium hydroxide as intracanal medicaments on: Intensity of postoperative pain levels of MMP -9 in Periapical Fluids. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Intracanal Dressing, Apical Periodontitis, Calcium Hydroxide
- What is being tested?
- Bio-C Temp Intracanal Medication and Calcium Hydroxide Intracanal medication
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- Aug 2025to Jul 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 18 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Age between 18-50 years old.
- Males and females.
- Healthy patients categorized as I or II according to The American Society of Anesthesiologists.
- (ASA I or II), with no underlying allergies.
- Single-rooted mandibular premolar teeth, having single root canal:
- Diagnosed clinically with pulp necrosis.
Show all 10Show fewer
- Absence of spontaneous pulpal pain.
- Slight widening in the periodontal membrane space or with periapical radiolucency not exceeding 2*2 mm radiographically.
- Patients accepting to participate in the trial.
- Patients who can understand pain scale and can sign the informed consent
Who cannot join
- Medically compromised patients having significant systemic disorders (ASA III or IV).
- Pregnant females.
- If analgesics or antibiotics have been administrated by the patient during the past 24 hours preoperatively as it might alter their pain perception.
- Teeth with multiple canals. 9
- Teeth that show association with acute periapical abscess, swelling or fistulous tract.
- Teeth with vital pulp.
Show all 13Show fewer
- Non-restorable teeth or teeth that could not be adequately isolated with a rubber dam.
- Immature teeth.
- Teeth with greater than grade I mobility or pocket depth greater than 4 mm.
- Teeth showing radiographic evidence of external or internal root resorption, vertical root fracture, perforation or calcification.
- Patients with two or more adjacent teeth requiring endodontic treatment.
- Patients reporting bruxism, clenching or TMJ problems.
- Inability to perceive the given instructions.
About this study
Official title: Effect of Bio-C Temp Versus Calcium Hydroxide as an Intracanal Dressing on Postoperative Pain Intensity and Periapical MMP-9 Level in Patients With Necrotic Pulp: A Randomized Clinical Trial
To compare the effect of Bio-C Temp Bioceramic intracanal dressing versus calcium hydroxide as intracanal medicaments on:
- Intensity of postoperative pain
- levels of MMP -9 in Periapical Fluids.
- Conditions
- Intracanal Dressing, Apical Periodontitis, Calcium Hydroxide, Biomarkers, Inflammatory Mediators
- Being tested
- Bio-C Temp Intracanal Medication, Calcium Hydroxide Intracanal medication
- Keywords
- Bio-C Temp, Calcium Hydroxide, Intracanal medicament, Matrix Metalloproteinase 9, Biomarkers, Post operative pain
- Medical subject headings
- Periapical Periodontitis, Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bio-C Temp Intracanal MedicationDrug
Also called Bioceramic intracanal dressing
Bio-C Temp Bioceramic intracanal dressing in the form of injectable premixed paste
Calcium Hydroxide Intracanal medicationDrug
Calcium Hydroxide intracanal dressing in the form of injectable premixed paste
| Study group | Role | What they receive |
|---|---|---|
| Bio-C Temp | Experimental | This group will Receive Bio-C Temp Bioceramic paste as intracanal dressing Receives: Drug: Bio-C Temp Intracanal Medication |
| Calcium Hydroxide | Active comparator | This group will Receive Calcium Hydroxide paste as intracanal dressing Receives: Drug: Calcium Hydroxide Intracanal medication |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intensity of post-operative pain
Intensity of post-operative pain as measured by Numerical Rating Scale (NRS)
Measured: 6 hours post-instrumentation
Intensity of post-operative pain
Intensity of post-operative pain as measured by Numerical Rating Scale (NRS)
Measured: 12 hours post-instrumentation
Intensity of post-operative pain
Intensity of post-operative pain as measured by Numerical Rating Scale (NRS)
Measured: 24 hours post-instrumentation
Intensity of post-operative pain
Intensity of post-operative pain as measured by Numerical Rating Scale (NRS)
Measured: 48 hours post-instrumentation
Intensity of post-operative pain
Intensity of post-operative pain as measured by Numerical Rating Scale (NRS)
Measured: 6 hours post-obturation
Intensity of post-operative pain
Intensity of post-operative pain as measured by Numerical Rating Scale (NRS)
Measured: 12 hours post-obturation
Intensity of post-operative pain
Intensity of post-operative pain as measured by Numerical Rating Scale (NRS)
Measured: 24 hours post-obturation
Intensity of post-operative pain
Intensity of post-operative pain as measured by Numerical Rating Scale (NRS)
Measured: 48 hours post-obturation
Secondary outcomes (2)
Periapical MMP-9 level
Level Of MMP-9 Enzyme in the periapical tissue fluid, quantified by ELISA
Measured: at the first visit post- instrumentation
Periapical MMP-9 Level
Level of MMP-9 enzyme in the periapical tissue fluid, Quantified by ELISA
Measured: After 1 week at the second visit (pre-obturation)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2025
- Study startAug 2025 (estimated)
- Primary completionJul 2026 (estimated)
- Study completionJul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intracanal DressingStudies of the same condition, open and under way.
- More trials run by Cairo 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mennatallah Alaa El-Dien Mohamed, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07101029
- Sponsor's protocol ID
- MennaalaaCU25
- Status last verified
- Jul 2025
- First submitted
- 25 Jul 2025
- Last updated
- 3 Aug 2025
- 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 3 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Bio-C Temp Versus Calcium Hydroxide as an Intracanal Dressing on Postoperative Pain Intensity and Periapical MMP-9 Level in Patients With Necrotic Pulp: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT07101029
- Acronym / sponsor ID
- MennaalaaCU25
- Conditions
- Intracanal Dressing, Apical Periodontitis, Calcium Hydroxide, Biomarkers, Inflammatory Mediators
- Keywords
- Bio-C Temp, Calcium Hydroxide, Intracanal medicament, Matrix Metalloproteinase 9, Biomarkers, Post operative pain
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- Aug 2025 (estimated)
- Primary completion
- Jul 2026 (estimated)
- Study completion
- Jul 2026 (estimated)
- First posted
- 3 Aug 2025 (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.
To compare the effect of Bio-C Temp Bioceramic intracanal dressing versus calcium hydroxide as intracanal medicaments on:
- Intensity of postoperative pain
- levels of MMP -9 in Periapical Fluids.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Bio-C Temp | Experimental | Drug: Bio-C Temp Intracanal MedicationThis group will Receive Bio-C Temp Bioceramic paste as intracanal dressing |
| Calcium Hydroxide | Active comparator | Drug: Calcium Hydroxide Intracanal medicationThis group will Receive Calcium Hydroxide paste as intracanal dressing |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- Age between 18-50 years old.
- Males and females.
- Healthy patients categorized as I or II according to The American Society of Anesthesiologists.
- (ASA I or II), with no underlying allergies.
- Single-rooted mandibular premolar teeth, having single root canal:
Key exclusion criteria (13 listed)
- Medically compromised patients having significant systemic disorders (ASA III or IV).
- Pregnant females.
- If analgesics or antibiotics have been administrated by the patient during the past 24 hours preoperatively as it might alter their pain perception.
- Teeth with multiple canals. 9
- Teeth that show association with acute periapical abscess, swelling or fistulous tract.
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 |
|---|---|---|
| Bio-C Temp Intracanal MedicationAlso: Bioceramic intracanal dressingBio-C Temp Bioceramic intracanal dressing in the form of injectable premixed paste | Drug | Bio-C Temp |
| Calcium Hydroxide Intracanal medicationCalcium Hydroxide intracanal dressing in the form of injectable premixed paste | Drug | Calcium Hydroxide |
Primary outcome
Intensity of post-operative pain
Time frame: 6 hours post-instrumentation
Intensity of post-operative pain as measured by Numerical Rating Scale (NRS)
Intensity of post-operative pain
Time frame: 12 hours post-instrumentation
Intensity of post-operative pain as measured by Numerical Rating Scale (NRS)
Intensity of post-operative pain
Time frame: 24 hours post-instrumentation
Intensity of post-operative pain as measured by Numerical Rating Scale (NRS)
Intensity of post-operative pain
Time frame: 48 hours post-instrumentation
Intensity of post-operative pain as measured by Numerical Rating Scale (NRS)
Intensity of post-operative pain
Time frame: 6 hours post-obturation
Intensity of post-operative pain as measured by Numerical Rating Scale (NRS)
Intensity of post-operative pain
Time frame: 12 hours post-obturation
Intensity of post-operative pain as measured by Numerical Rating Scale (NRS)
Intensity of post-operative pain
Time frame: 24 hours post-obturation
Intensity of post-operative pain as measured by Numerical Rating Scale (NRS)
Intensity of post-operative pain
Time frame: 48 hours post-obturation
Intensity of post-operative pain as measured by Numerical Rating Scale (NRS)
2 secondary outcomes
Periapical MMP-9 level
Time frame: at the first visit post- instrumentation
Periapical MMP-9 Level
Time frame: After 1 week at the second visit (pre-obturation)
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 3 Aug 2025.
Related trials for Intracanal Dressing
RecruitingPhase 1
Biological, Radiographic and Clinical Evaluation of Various Inter-Visit Root Canal Dressings in Retreatment Cases
Intervention Studies, ASA Physical Status I
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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Bio-C Temp Intracanal Medication and Calcium Hydroxide Intracanal medication in people with Intracanal Dressing and Apical Periodontitis, run by Cairo 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 10 inclusion and 13 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: opening soon, as of the sponsor's last update on 3 Aug 2025. 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 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?
Intensity of post-operative pain (time frame: 6 hours post-instrumentation). The study lists 8 primary outcomes in all. 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 3 Aug 2025.