Pulpitis - IrreversibleNCT07522723
Clinical and Radiographic Assessment of Bio C Repair, Biodentine and Mineral Trioxide Aggregate
A study testing Biodentine and Bio C repair in people with Pulpitis - Irreversible, run by Cairo University.
Trial summary
The aim of this study is to assess Clinical and Radiographical effect of Bio C repair, Biodentine and Mineral Trioxide Aggregate when used as pulpotomy Agents in Immature Permanent Molars with Pulpits. Read more about this study
- Who is it for?
- Ages 6 to 10 yearsHealthy volunteers can take part
- Conditions the study is for
- Pulpitis - Irreversible
- What is being tested?
- Biodentine and Bio C repair
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 20 Apr 2026to May 2027
- 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 6 to 10 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Children aged 6-10 years with asymptomatic/symptomatic disease and having vital immature permanent posterior teeth with clinical exposure to dental caries of the pulp and bleeding.
- Posterior teeth had deep caries with pulp exposure.
- Posterior teeth that exhibited preoperative symptoms, such as referred pain, spontaneous pain or pain induced during thermal and cold sensitivity tests, with a range of symptoms that can last from seconds to hours compared to the control teeth.
- Posterior teeth without prominent radiolucency in the furcation or periapical regions.
- The posterior teeth could be restored.
- Children with prior parental consent.
Who cannot join
- • (1) Patients with contraindications of the to-be-performed dental treatment.
- (2) Teeth with completed VPT or RCT.
- (3) Teeth with furcation, prominent radiolucency in the periapical regions, or external or internal resorption.
- (4) Teeth with pulpitis attributed to tooth fracture, cracking, periodontitis or wedge-shaped defects.
- (5) Teeth without any response to experiments of vitality. (
- 6) Teeth with formed root/closed apex.
- (7) Teeth with edema, fistula and excessive mobility not associated with periodontal disease.
About this study
Official title: Clinical and Radiographic Assessment of Bio C Repair, Biodentine and Mineral Trioxide Aggregate Used As Pulpotomy Agents In Vital Immature Permanent Molars With Irreversible Pulpits. A Randomized Control Trial
The aim of this study is to assess Clinical and Radiographical effect of Bio C repair, Biodentine and Mineral Trioxide Aggregate when used as pulpotomy Agents in Immature Permanent Molars with Pulpits.
- Conditions
- Pulpitis - Irreversible
- Being tested
- Biodentine, Bio C repair
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BiodentineOther
First introduced in 2009 as a "dentin replacement" agent, biodentin is a "bioactive replacement for dentine." It is also available under the trade name Septodont. The material is reported to have better physical and biological properties than other tricalcium silicate cements such mineral trioxide aggregate (MTA) an d BioaggregateTM.
Bio C repairOther
A new calcium silicate-based restorative cement called Bio-C Repair (Angelus, Londrina, Brazil) exhibits bioactivity and promotes tissue repair and biomineralisation. This material has a number of benefits, including reduced susceptibility to moisture as compared to traditional substitutes and easy application via a convenient single-use syringe size, which improves clinical efficacy. (Torres et al., 2020).
By encouraging bioactivity, biomineralisation, and hard tissue repair, Bio C Repair is used in immature permanent teeth to support apexogenesis (continuous root growth) and pulpotomy. It functions as a biocompatible pulp dressing, promoting tissue regeneration, sealing the pulp chamber, and outperforming conventional techniques with better handling and shorter setting periods.
| Study group | Role | What they receive |
|---|---|---|
| Biodentine | Experimental | Pulpotomy using Biodentine in carious Immature permanent molars with irreversible pulpitis. Receives: Other: Biodentine |
| Bio C repair | Experimental | Pulpotomy using Bio C repair in carious Immature permanent molars with irreversible pulpitis. Receives: Other: Bio C repair |
| MTA | Active comparator | Mineral trioxide aggregate in carious Immature permanent molars with irreversible pulpitis. Receives: Other: Biodentine; Other: Bio C repair |
What is being measured
The primary outcome is the main question the study is designed to answer.
Radiographic examination of complete apical closure
Digital Radiographic examination using visual examination of the teeth were made using the TPC paralleling device
Measured: 12 months
Secondary outcomes (4)
Presence of pain
Pain assessment was done by the VAS between 0 and 10, with 0 denoting no pain and 10 denoting severe pain.
Measured: 12 months
The presence of Swelling
Visual examination
Measured: 12 months
The presence of Sinus or fistula
Visual examination
Measured: 12 months
tenderness associated with the tooth.
Wong-Baker FACES Pain Rating Scale (0-10)
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2026
- Study start20 Apr 2026 (estimated)
- Primary completionApr 2027 (estimated)
- Study completionMay 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulpitis - IrreversibleStudies 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
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alaa Yasser ElSheikh, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07522723
- Sponsor's protocol ID
- 4-2026
- Status last verified
- Apr 2026
- First submitted
- 4 Apr 2026
- Last updated
- 13 Apr 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical and Radiographic Assessment of Bio C Repair, Biodentine and Mineral Trioxide Aggregate Used As Pulpotomy Agents In Vital Immature Permanent Molars With Irreversible Pulpits. A Randomized Control Trial
- ClinicalTrials.gov ID
- NCT07522723
- Acronym / sponsor ID
- 4-2026
- Conditions
- Pulpitis - Irreversible
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 20 Apr 2026 (estimated)
- Primary completion
- Apr 2027 (estimated)
- Study completion
- May 2027 (estimated)
- First posted
- 13 Apr 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 study is to assess Clinical and Radiographical effect of Bio C repair, Biodentine and Mineral Trioxide Aggregate when used as pulpotomy Agents in Immature Permanent Molars with Pulpits.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Biodentine | Experimental | Other: BiodentinePulpotomy using Biodentine in carious Immature permanent molars with irreversible pulpitis. |
| Bio C repair | Experimental | Other: Bio C repairPulpotomy using Bio C repair in carious Immature permanent molars with irreversible pulpitis. |
| MTA | Active comparator | Other: Biodentine, Other: Bio C repairMineral trioxide aggregate in carious Immature permanent molars with irreversible pulpitis. |
Who may qualify
- Ages
- 6 to 10 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- Children aged 6-10 years with asymptomatic/symptomatic disease and having vital immature permanent posterior teeth with clinical exposure to dental caries of the pulp and bleeding.
- Posterior teeth had deep caries with pulp exposure.
- Posterior teeth that exhibited preoperative symptoms, such as referred pain, spontaneous pain or pain induced during thermal and cold sensitivity tests, with a range of symptoms that can last from seconds to hours compared to the control teeth.
- Posterior teeth without prominent radiolucency in the furcation or periapical regions.
- The posterior teeth could be restored.
Key exclusion criteria (7 listed)
- • (1) Patients with contraindications of the to-be-performed dental treatment.
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 |
|---|---|---|
| BiodentineFirst introduced in 2009 as a "dentin replacement" agent, biodentin is a "bioactive replacement for dentine." It is also available under the trade name Septodont. The material is reported to have better physical and biological properties than other tricalcium silicate cements such mineral trioxide aggregate (MTA) an d BioaggregateTM. | Other | Biodentine, MTA |
| Bio C repairA new calcium silicate-based restorative cement called Bio-C Repair (Angelus, Londrina, Brazil) exhibits bioactivity and promotes tissue repair and biomineralisation. This material has a number of benefits, including reduced susceptibility to moisture as compared to traditional substitutes and easy application via a convenient single-use syringe size, which improves clinical efficacy. (Torres et al., 2020). By encouraging bioactivity, biomineralisation, and hard tissue repair, Bio C Repair is used in immature permanent teeth to support apexogenesis (continuous root growth) and pulpotomy. It functions as a biocompatible pulp dressing, promoting tissue regeneration, sealing the pulp chamber, and outperforming conventional techniques with better handling and shorter setting periods. | Other | Bio C repair, MTA |
Primary outcome
Radiographic examination of complete apical closure
Time frame: 12 months
Digital Radiographic examination using visual examination of the teeth were made using the TPC paralleling device
4 secondary outcomes
Presence of pain
Time frame: 12 months
The presence of Swelling
Time frame: 12 months
The presence of Sinus or fistula
Time frame: 12 months
tenderness associated with the tooth.
Time frame: 12 months
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 13 Apr 2026.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Biodentine and Bio C repair in people with Pulpitis - Irreversible, 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 6 inclusion and 7 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 13 Apr 2026. 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.
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?
Radiographic examination of complete apical closure (time frame: 12 months). 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 13 Apr 2026.