Post Operative PainNCT07075055
Impact of a New Bioceramic Based Intracanal Medication
A study testing Metapaste Calcium Hydroxide and Bio C-Temp in people with Post Operative Pain, 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 pathological changes seen in some periradicular and periapical cases are due to the presence of microorganisms, and their… Read more about this study
- Who is it for?
- Ages 18 to 40 years
- Conditions the study is for
- Post Operative Pain
- What is being tested?
- Metapaste Calcium Hydroxide and Bio C-Temp
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jul 2025to 10 Jul 2026
- Phase
- Interventional
- 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 18 to 40 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.
- Patients with old age.
Show all 10Show fewer
- Teeth with periodontal involvement.
- Teeth with vertical root fractures.
- Non-restorable teeth.
- Cases with previously initiated endodontic treatment.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Impact of a New Bioceramic Based Intracanal Medication on Postoperative Pain and Periapical Healing. Double Blind 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 pathological 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.
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.
- Conditions
- Post Operative Pain
- Being tested
- Metapaste Calcium Hydroxide, Bio C-Temp
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Metapaste Calcium HydroxideOther
Also called Bio C-Temp
To compare the effect of calcium hydroxide and Bio-C Temp as intra canal medications on postoperative pain via VAS and periapical healing via CBCT
Bio C-TempOther
Bio C-Temp
| Study group | Role | What they receive |
|---|---|---|
| Metapaste Calcium Hydroxide | Active comparator | About 30 healthy patients of both genders presented with periapical radiolucency will subject to complete preparation of the root canal system using the (Metapaste Calcium Hydroxide(Pre-mixed paste) as an intracanal medicament. Receives: Other: Metapaste Calcium Hydroxide |
| Bio C-Temp | Active comparator | About 30 healthy patients of both genders presented with periapical radiolucency will subject to complete preparation of the root canal system using the (Bio C-Temp) as an intracanal medicament. Receives: Other: Bio C-Temp |
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment of Postoperative Pain
Patients will be evaluated for postoperative pain via (NRS) to record the intensity of pain.as follows: 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: from 0 hours to 2 weeks after the procedure
Secondary outcomes (1)
Periapical Healing
Periapical healing will be evaluated by comparing the size of the initial lesion pre-operatively and postoperatively (after 6 and 12 months), using periapical radiographs and CBCT. This will be aggregated in percentage (%).
Measured: After 6 months to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2025
- Study start1 Jul 2025
- Primary completion1 Jul 2026
- Study completion10 Jul 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post Operative PainStudies 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
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Minia University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hanaa Ewas Korany Mabrouk, Minia University
- Investigators
- Wael HUESSIEN KAMEL, Professor, Study chair, Department of Endodontics, Faculty of Dentistry,Al-Azhar University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07075055
- Sponsor's protocol ID
- Intracanal Bioceramic
- Status last verified
- Jun 2025
- First submitted
- 2 Jul 2025
- Last updated
- 3 Nov 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of a New Bioceramic Based Intracanal Medication on Postoperative Pain and Periapical Healing. Double Blind Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT07075055
- Acronym / sponsor ID
- Intracanal Bioceramic
- Conditions
- Post Operative Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Minia UniversityUniversity, hospital or other
- Study start
- 1 Jul 2025 (actual)
- Primary completion
- 1 Jul 2026 (actual)
- Study completion
- 10 Jul 2026 (actual)
- First posted
- 20 Jul 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.
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 pathological 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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Metapaste Calcium Hydroxide | Active comparator | Other: Metapaste Calcium HydroxideAbout 30 healthy patients of both genders presented with periapical radiolucency will subject to complete preparation of the root canal system using the (Metapaste Calcium Hydroxide(Pre-mixed paste) as an intracanal medicament. |
| Bio C-Temp | Active comparator | Other: Bio C-TempAbout 30 healthy patients of both genders presented with periapical radiolucency will subject to complete preparation of the root canal system using the (Bio C-Temp) as an intracanal medicament. |
Who may qualify
- Ages
- 18 to 40 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 (10 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.
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-TempTo compare the effect of calcium hydroxide and Bio-C Temp as intra canal medications on postoperative pain via VAS and periapical healing via CBCT | Other | Metapaste Calcium Hydroxide |
| Bio C-TempBio C-Temp | Other | Bio C-Temp |
Primary outcome
Treatment of Postoperative Pain
Time frame: from 0 hours to 2 weeks after the procedure
Patients will be evaluated for postoperative pain via (NRS) to record the intensity of pain.as follows: 0 reading represents "no pain" ; 1- 3 reading represents "mild pain" ; 4- 6 reading represents "moderate pain" and 7- 10 reading represents "severe pain".
1 secondary outcome
Periapical Healing
Time frame: After 6 months to 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2026.
- Individual participant dataSharing planned: No
Related trials for Post Operative Pain
RecruitingPhase 4
ESP Blocks for Posterior Spinal Fusion
Postoperative Pain
Recruiting
Effect of Cryotherapeutic and Nanotherapeutic Sodium Hypochlorite on Post-Operative Endodontic Pain.
Symptomatic Irreversible Pulpitis, Symptomatic Apical Periodontitis
RecruitingPhase 2
REctus Sheath Trial
Acute Pain, Postoperative Pain, Acute
Not yet recruiting
Effect of Pectoral Nerve Block (PECS) Using Magnesium Sulfate Added to Dexamethasone on Quality of Recovery and Chronic Post-Mastectomy Pain
Breast Cancer, Postoperative Pain
Active, not recruitingPhase 4
Effect of Dexmedetomidine on Postoperative Pain in Spinal Anesthesia for Cesarean Section at Assuit University Hospital
Cesarean Section
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.
Wael HUESSIEN KAMEL, Professor study chair
Department of Endodontics, Faculty of Dentistry,Al-Azhar 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 and Bio C-Temp in people with Post Operative Pain, 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 10 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: finished, as of the sponsor's last update on 3 Nov 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Treatment of Postoperative Pain (time frame: from 0 hours to 2 weeks after the procedure). 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 Nov 2026.