Periapical HealingNCT07892703
Evaluation of Three Different Intra-canal Medicaments
A study testing Metapaste Calcium Hydroxide in people with Periapical Healing, run by Minia University at 1 site in Egypt.
Trial summary
Periapical lesions are the commonly occurring pathologic lesions that affect the periradicular tissues of the tooth . This lesion can be classified as granuloma, cystic, or abscess .The pathologic changes seen in some periradicular and periapical cases are due to the presence of microorganisms, and their byproducts. Read more about this study
- Who is it for?
- Ages 20 to 45 years
- Conditions the study is for
- Periapical Healing
- What is being tested?
- Metapaste Calcium Hydroxide
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteEgypt
- Study dates
- 16 Dec 2025to 16 Dec 2026
- Phase
- Interventional
- 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 20 to 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patients with mature teeth.
- Patients with periapical periodontitis.
- Maxillary anterior teeth only will be involved.
- Patients should be free from any systemic disease that may affect normal healing and predictable outcome.
- Patients who will agree to the consent and will commit to follow-up period.
Who cannot join
- Patients with immature roots.
- Patients with any systemic disease that may affect normal healing.
- Patients with swelling.
- Pregnant females.
- Patients who could/would not participate in a 1-year follow-up. 6-Patients with old age.
- Teeth with periodontal involvement. 8-Teeth with vertical root fractures.
- Non-restorable teeth.
- cases with previously initiated endodontic treatment.
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
Department of Endodontics, Faculty of Dentistry Minia University
Minya
Dalia Ali Ahmed Moukarab, M.D, +201068121523, dalia.mokarab@mu.edu.eg
Nourhan Ali Abdelhaleem, M.D, +201000188224, norhan.ali@mu.edu.eg
About this study
Official title: Evaluation of Three Different Intra-canal Medicaments on Postoperative Pain and Periapical Healing: Randomized Clinical Trial
Periapical lesions are the commonly occurring pathologic lesions that affect the periradicular tissues of the tooth . This lesion can be classified as granuloma, cystic, or abscess .The pathologic changes seen in some periradicular and periapical cases are due to the presence of microorganisms, and their byproducts. These released toxins have the ability to diffuse through inflamed pulpal tissue and get into the periapical area. In a necrotic pulp, the lack of blood flow in the root prevents host immunity from eliminating the infection
Read the detailed description
Endodontic treatment is essentially directed towards the prevention and control of pulpal and periradicular infections. Complete chemomechanical preparation may be considered an essential step in root canal disinfection. However total elimination of bacteria is difficult to accomplish. by remaining in the root canal between appointments, intracanal medicament may help to eliminate bacteria.
A medicament is an antimicrobial agent that is placed inside the root canal between treatment appointments in an attempt to destroy remaining microorganisms and prevent reinfection Thus, they may be utilized to kill bacteria, reduce inflammation (and thereby reduce pain), help eliminate apical exudate, control inflammatory root resorption and prevent contamination between appointments.When intracanal medicaments were not used between appointments, bacterial numbers increased rapidly.
The BIO-C® TEM has emerged as the first intracanal bioceramic medication of Endodontics, indicated for cases of treatment and retreatment due to its high pH to its antibacterial, bacteriostatic, anti- inflammatory and mineralization- -inducing action. Since it is a bioactive product, BIO-C® TEMP interacts with the surrounding tissue, stimulating healing. The tissue system responds to the material as if it was a natural tissue. It has found its way in treatment of diverse cases: pulpitis, pulp necrosis, periapical lesion, persistent fistula, inflammatory or purulent exudate, perforation, apexification, external and internal resorption. It has been recommended not only for its actions, but also because it is a ready-to-use syringe, easy to insert into the root canal and with no painful symptomatology, even in cases where it has been extruded through the apical foramen.
Favourable outcome is due to:
Gradual release of Ca2+ Periodic exchange is not required, Biocompatible( Absence of symptomatology), High alkalinity (pH ~12)( Unsuitable environment for bacterial growth), Easy to remove( Clinical time optimization),and High radiopacity (Excellent radiographic visualization).
the intra-canal procedures based on the maximum elimination of the irritant including antimicrobial intra-canal dressing are valuable tool to control endodontic infections and theoretically prevent postoperative pain.
Periapical lesions, inflammatory reactions caused by bacterial infections in the periapical area of teeth, require effective treatment for optimal healing For decades non-setting Ca(OH)2 has been the gold standard intracanal medicament in endodontic procedures to promote the healing of periapical lesions.
Triple-Antibiotic Paste [TAP] has been recommended for intra-canal disinfection, TAP has been shown to be the most effective. TAP, a mix of three different antibiotics, provides effective action against different microorganisms and produces outstanding results. The combined action of three different antibiotics also helps reduce the chances of microbial resistance. As there are several advantages and disadvantages associated with the different antimicrobial agents available, the selection of the best is essential.
- Conditions
- Periapical Healing
- Being tested
- Metapaste Calcium Hydroxide
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Metapaste Calcium HydroxideProcedure or surgery
Also called Bio C-Temp, Triple Antibiotic
To compare between the effect of calcium hydroxide, Bio-C Temp and Triple Antibiotic Paste as intra canal medicaments on postoperative pain and healing via CBCT.
| Study group | Role | What they receive |
|---|---|---|
| Group A (Metapaste) | Experimental | About 15 participants will be subjected After complete preparation of the root canal system to placing the Metapaste in the canal using an amalgam carrier and packed with large endodontic pluggers.
* The access cavity will be sealed with Cavit. Patients will be recalled after 2 weeks, and the tooth will be examined for postoperative pain evaluation. Receives: Procedure: Metapaste Calcium Hydroxide |
| Group B (Bio C-Temp) | Experimental | About 15 participants will be subjected After complete preparation of the root canal system to placing the Bio C-Temp in the canal using an amalgam carrier and packed with large endodontic pluggers.
-The access cavity will be sealed with Cavit. Patients will be recalled after 2 weeks, and the tooth will be examined for postoperative pain evaluation. Receives: Procedure: Metapaste Calcium Hydroxide |
| Group C (Triple Antibiotic Paste) | Experimental | About 15 participants will be subjected After complete preparation of the root canal system to placing Triple Antibiotic Paste in the canal using an amalgam carrier and packed with large endodontic pluggers.
-The access cavity will be sealed with Cavit. Patients will be recalled after 2 weeks, and the tooth will be examined for postoperative pain evaluation Receives: Procedure: Metapaste Calcium Hydroxide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post Operative Pain
Intensity of post- operative pain level will be recorded at 6, 12, 24, 48, 72-hours and 7 days after Endodontic treatment by numerical Rating Scale using Numerical Rate Scale (NRS) and will be used to record the patients' pain levels. The NRS (0-10 scale) where as: 0 reading represents "no pain" ; 1- 3 reading represents "mild pain" ; 4- 6 reading represents "moderate pain" and 7- 10 reading represents "severe pain".
Measured: 7 Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2026
- Study start16 Dec 2025
- Primary completion10 Dec 2026 (estimated)
- Study completion16 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Periapical HealingStudies of the same condition, open and under way.
- More trials run by Minia 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Minia University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shimaa Mohamed Abdelhamed, Minia University
- Investigators
- Dalia Ali Ahmed Moukarab, M.D, Study chair, Professor and head of department of Endodontics, Faculty of Dentistry, Minia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07892703
- Sponsor's protocol ID
- intra-canal medicaments
- Status last verified
- Dec 2025
- First submitted
- 18 Oct 2026
- Last updated
- 23 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Three Different Intra-canal Medicaments on Postoperative Pain and Periapical Healing: Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT07892703
- Acronym / sponsor ID
- intra-canal medicaments
- Conditions
- Periapical Healing
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- Minia UniversityUniversity, hospital or other
- Study start
- 16 Dec 2025 (actual)
- Primary completion
- 10 Dec 2026 (estimated)
- Study completion
- 16 Dec 2026 (estimated)
- First posted
- 23 Oct 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.
Periapical lesions are the commonly occurring pathologic lesions that affect the periradicular tissues of the tooth . This lesion can be classified as granuloma, cystic, or abscess .The pathologic changes seen in some periradicular and periapical cases are due to the presence of microorganisms, and their byproducts. These released toxins have the ability to diffuse through inflamed pulpal tissue and get into the periapical area. In a necrotic pulp, the lack of blood flow in the root prevents host immunity from eliminating the infection
Detailed description
Endodontic treatment is essentially directed towards the prevention and control of pulpal and periradicular infections. Complete chemomechanical preparation may be considered an essential step in root canal disinfection. However total elimination of bacteria is difficult to accomplish. by remaining in the root canal between appointments, intracanal medicament may help to eliminate bacteria.
A medicament is an antimicrobial agent that is placed inside the root canal between treatment appointments in an attempt to destroy remaining microorganisms and prevent reinfection Thus, they may be utilized to kill bacteria, reduce inflammation (and thereby reduce pain), help eliminate apical exudate, control inflammatory root resorption and prevent contamination between appointments.When intracanal medicaments were not used between appointments, bacterial numbers increased rapidly.
The BIO-C® TEM has emerged as the first intracanal bioceramic medication of Endodontics, indicated for cases of treatment and retreatment due to its high pH to its antibacterial, bacteriostatic, anti- inflammatory and mineralization- -inducing action. Since it is a bioactive product, BIO-C® TEMP interacts with the surrounding tissue, stimulating healing. The tissue system responds to the material as if it was a natural tissue. It has found its way in treatment of diverse cases: pulpitis, pulp necrosis, periapical lesion, persistent fistula, inflammatory or purulent exudate, perforation, apexification, external and internal resorption. It has been recommended not only for its actions, but also because it is a ready-to-use syringe, easy to insert into the root canal and with no painful symptomatology, even in cases where it has been extruded through the apical foramen.
Favourable outcome is due to:
Gradual release of Ca2+ Periodic exchange is not required, Biocompatible( Absence of symptomatology), High alkalinity (pH ~12)( Unsuitable environment for bacterial growth), Easy to remove( Clinical time optimization),and High radiopacity (Excellent radiographic visualization).
the intra-canal procedures based on the maximum elimination of the irritant including antimicrobial intra-canal dressing are valuable tool to control endodontic infections and theoretically prevent postoperative pain.
Periapical lesions, inflammatory reactions caused by bacterial infections in the periapical area of teeth, require effective treatment for optimal healing For decades non-setting Ca(OH)2 has been the gold standard intracanal medicament in endodontic procedures to promote the healing of periapical lesions.
Triple-Antibiotic Paste [TAP] has been recommended for intra-canal disinfection, TAP has been shown to be the most effective. TAP, a mix of three different antibiotics, provides effective action against different microorganisms and produces outstanding results. The combined action of three different antibiotics also helps reduce the chances of microbial resistance. As there are several advantages and disadvantages associated with the different antimicrobial agents available, the selection of the best is essential.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group A (Metapaste) | Experimental | Procedure: Metapaste Calcium HydroxideAbout 15 participants will be subjected After complete preparation of the root canal system to placing the Metapaste in the canal using an amalgam carrier and packed with large endodontic pluggers. * The access cavity will be sealed with Cavit. Patients will be recalled after 2 weeks, and the tooth will be examined for postoperative pain evaluation. |
| Group B (Bio C-Temp) | Experimental | Procedure: Metapaste Calcium HydroxideAbout 15 participants will be subjected After complete preparation of the root canal system to placing the Bio C-Temp in the canal using an amalgam carrier and packed with large endodontic pluggers. -The access cavity will be sealed with Cavit. Patients will be recalled after 2 weeks, and the tooth will be examined for postoperative pain evaluation. |
| Group C (Triple Antibiotic Paste) | Experimental | Procedure: Metapaste Calcium HydroxideAbout 15 participants will be subjected After complete preparation of the root canal system to placing Triple Antibiotic Paste in the canal using an amalgam carrier and packed with large endodontic pluggers. -The access cavity will be sealed with Cavit. Patients will be recalled after 2 weeks, and the tooth will be examined for postoperative pain evaluation |
Who may qualify
- Ages
- 20 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Patients with mature teeth.
- Patients with periapical periodontitis.
- Maxillary anterior teeth only will be involved.
- Patients should be free from any systemic disease that may affect normal healing and predictable outcome.
- Patients who will agree to the consent and will commit to follow-up period.
Key exclusion criteria (8 listed)
- Patients with immature roots.
- Patients with any systemic disease that may affect normal healing.
- Patients with swelling.
- Pregnant females.
- Patients who could/would not participate in a 1-year follow-up. 6-Patients with old age.
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 |
|---|---|---|
| Metapaste Calcium HydroxideAlso: Bio C-Temp, Triple AntibioticTo compare between the effect of calcium hydroxide, Bio-C Temp and Triple Antibiotic Paste as intra canal medicaments on postoperative pain and healing via CBCT. | Procedure or surgery | Group A (Metapaste), Group B (Bio C-Temp), Group C (Triple Antibiotic Paste) |
Primary outcome
Post Operative Pain
Time frame: 7 Days
Intensity of post- operative pain level will be recorded at 6, 12, 24, 48, 72-hours and 7 days after Endodontic treatment by numerical Rating Scale using Numerical Rate Scale (NRS) and will be used to record the patients' pain levels. The NRS (0-10 scale) where as: 0 reading represents "no pain" ; 1- 3 reading represents "mild pain" ; 4- 6 reading represents "moderate pain" and 7- 10 reading represents "severe pain".
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 23 Oct 2026.
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Clinical and Inflammatory Outcomes of Regenerative Endodontic Treatment Using Injectable Platelet-Rich Fibrin in Mature Necrotic Teeth With Chronic Apical Periodontitis.
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Early Healing of Apical Periodontitis After Root Canal Treatment With Bioceramic and Calcium Hydroxide Medicaments: Evaluation Using PAI and ImageJ
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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.
Dalia Ali Ahmed Moukarab, M.D study chair
Professor and head of department of Endodontics, Faculty of Dentistry, Minia University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Metapaste Calcium Hydroxide in people with Periapical Healing, run by Minia 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 5 inclusion and 8 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 23 Oct 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.
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 Shimaa Mohamed Abdelhamed, MSc (+201142155099, drshimamarof@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Post Operative Pain (time frame: 7 Days). 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 23 Oct 2026.