ApexogenesisNCT07883239
Bioceramic Repair Materials in Apexogenesis of Immature Permanent Molars
A study testing Bioceramic Repair Pulpotomy (BIO-C® REPAIR) and Mineral Trioxide Aggregate Pulpotomy (Biofactor MTA) in people with Apexogenesis and Pulp Exposure, Dental, run by Tanta University at 1 site in Egypt.
Trial summary
The present study was conducted to compare the clinical, radiographic, and tomographic outcomes of apexogenesis using Bio-C Repair and Biofactor MTA in immature permanent first molars with vital asymptomatic pulp exposure. Read more about this study
- Who is it for?
- Ages 6 to 8 years
- Conditions the study is for
- Apexogenesis, Pulp Exposure, Dental, MTA Vital Tooth Pulpotomy
- What is being tested?
- Bioceramic Repair Pulpotomy (BIO-C® REPAIR) and Mineral Trioxide Aggregate Pulpotomy (Biofactor MTA)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteEgypt
- Study dates
- 3 May 2024to 4 May 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 6 to 8 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Bilateral deep carious immature permanent first molars indicated for vital pulp therapy
- Vital teeth with no clinical signs or symptoms of irreversible pulpitis or pulp necrosis (Absence of spontaneous pain, tenderness to percussion or palpation, abnormal mobility and/ or soft tissue swelling, sinus tract, or fistula.)
- Teeth with restorable crowns.
- Hemostasis is achievable within a clinically acceptable period following pulp exposure.
- Absence of internal or external root resorption.
- Absence of periapical or furcal radiolucency.
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- Absence of widening of the periodontal ligament space.
- Absence of pulp canal obliteration (calcification).
- Absence of ankylosis.
- Normally surrounding alveolar bone and supporting periodontal structures.
Who cannot join
- presence of internal or external root resorption
- presence of periapical or furcal radiolucency.
- presence of widening of the periodontal ligament space
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical and Radiographic Evaluation of Bioceramic Repair in Apexogenesis of Immature Permanent Molars
The present study was conducted to compare the clinical, radiographic, and tomographic outcomes of apexogenesis using Bio-C Repair and Biofactor MTA in immature permanent first molars with vital asymptomatic pulp exposure.
Read the detailed description
Preservation of pulp vitality in immature permanent teeth is essential for continued root development and physiological apical closure. Apexogenesis is a conservative vital pulp therapy procedure that maintains the vitality of the radicular pulp, allowing continued root maturation, dentinal wall thickening, and strengthening of the tooth structure.
The present study was conducted to compare the clinical, radiographic, and tomographic outcomes of apexogenesis using Bio-C Repair and Biofactor MTA in immature permanent first molars with vital asymptomatic pulp exposure.
Thirty children aged 6-8 years presenting with bilateral deep carious lesions in immature permanent first molars requiring vital pulp therapy were enrolled in this split-mouth randomized clinical trial after obtaining informed parental consent. Only restorable teeth with vital pulps, no clinical signs or symptoms of irreversible pulp degeneration, and the ability to achieve hemostasis within a clinically acceptable period following pulp exposure were included.
Clinical and radiographic evaluations were performed at 6, 9, and 12 months postoperatively, while CBCT examinations were conducted before treatment and after 12 months to quantitatively assess root length, apical foramen diameter, and periapical bone density using region of interest (ROI) measurements.
- Conditions
- Apexogenesis, Pulp Exposure, Dental, MTA Vital Tooth Pulpotomy, Cone Beam Computed Tomography
- Being tested
- Bioceramic Repair Pulpotomy (BIO-C® REPAIR), Mineral Trioxide Aggregate Pulpotomy (Biofactor MTA)
- Keywords
- Bioceramics, Apexogenesis, Immature Permanent Teeth, Root Development
- Medical subject headings
- Dental Pulp Exposure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bioceramic Repair Pulpotomy (BIO-C® REPAIR)Procedure or surgery
Pre-procedure \& Isolation: Pre-procedural 0.2% chlorhexidine mouthwash for 30 seconds; local anesthesia (4% Articaine with 1:100,000 epinephrine); rubber dam isolation.
Surgical Procedure: Caries excavation and pulp chamber deroofing using a No. 330 bur; coronal pulp amputation using a sterile sharp excavator; irrigation with light saline flow; hemostasis achieved using a saline-moistened cotton pellet applied for 5 minutes.
Material Placement: Ready-to-use BIO-C® REPAIR applied directly over the pulp stumps according to manufacturer instructions and adapted with a slightly moistened sterile cotton pellet.
Restoration: Base layer sealed immediately with water-mixable glass ionomer cement (KROMOGLASS® 2) and restored with a nano-hybrid bulk-fill resin composite (Any-Com™ Nano Hybrid Bulk-Fill with One Coat Bond SL).
Mineral Trioxide Aggregate Pulpotomy (Biofactor MTA)Procedure or surgery
Pre-procedure \& Isolation: Identical pre-procedural rinse, local anesthesia administration, rubber dam isolation, caries excavation, coronal pulp amputation, saline irrigation, and 5-minute hemostasis protocol.
Material Placement: Biofactor MTA powder and liquid mixed according to manufacturer instructions, applied directly over the pulp stumps, and adapted with a slightly moistened sterile cotton pellet.
Restoration: Identical double-seal final restoration (glass ionomer base + nano-hybrid bulk-fill composite resin).
| Study group | Role | What they receive |
|---|---|---|
| Group I - Study Group (Bioceramic Repair / BIO-C® REPAIR) | Experimental | Immature permanent first molars with vital exposed pulp undergoing apexogenesis (deep pulpotomy) using a ready-to-use premixed bioceramic repair material (BIO-C® REPAIR). Receives: Procedure: Bioceramic Repair Pulpotomy (BIO-C® REPAIR) |
| Group II - Control Group (Biofactor MTA) | Active comparator | Immature permanent first molars with vital exposed pulp undergoing apexogenesis (deep pulpotomy) using a powder-liquid mineral trioxide aggregate (Biofactor MTA). Receives: Procedure: Mineral Trioxide Aggregate Pulpotomy (Biofactor MTA) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical Success Rate
Clinical success evaluated binary (Success/Failure) at follow-up intervals based on the total absence of clinical signs and symptoms:
Absence of spontaneous or persistent pain.
Absence of tenderness to percussion.
Absence of gingival inflammation surrounding the treated tooth.
Absence of abscess, draining sinus tract, or pathological tooth mobility.
Measured: Evaluated at 6, 9, and 12 months post-operative.
Radiographic Success Rate
Radiographic success evaluated binary (Success/Failure) via digital periapical radiographs based on standard endodontic criteria:
Absence of periapical radiolucency or osteolytic lesions.
Absence of internal or external root resorption.
Absence of widening of the periodontal ligament space.
Evidence of continued root development with progressive apical closure.
Measured: Evaluated at 6, 9, and 12 months post-operative.
Secondary outcomes (2)
Quantitative Root Length Increase (CBCT)
Root length measured in millimeters ($\text{mm}$) on sagittal Cone-Beam Computed Tomography (CBCT) sections. Measured from the cemento-enamel junction (CEJ, fixed reference point) to the most apical point of the root using OnDemand3D™ software. Maturogenesis/continued root lengthening is calculated as the net difference between baseline (immediate post-op) and 12-month follow-up scans.
Measured: Measured at Baseline (immediate post-op) and 12 months post-operative.
Apical Foramen Diameter Reduction / Closure (CBCT)
Apical foramen diameter measured in millimeters on sagittal CBCT sections at the widest dimensions of the open apex using OnDemand3D™ software. Progressive apical closure/apexogenesis is calculated as the net reduction in apical foramen diameter between baseline (immediate post-op) and 12-month follow-up scans.
Measured: Measured at Baseline (immediate post-op) and 12 months post-operative.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2026
- Study start3 May 2024
- Primary completion5 Aug 2025
- Study completion4 May 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for ApexogenesisStudies of the same condition, open and under way.
- More trials run by Tanta 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tanta University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shaimaa Shaban Mohamed El-desouky, Tanta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07883239
- Sponsor's protocol ID
- # PED-4-24-2176
- Status last verified
- Oct 2026
- First submitted
- 13 Oct 2026
- Last updated
- 20 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Taha NA, Abdulkhader SZ. Full Pulpotomy with Biodentine in Symptomatic Young Permanent Teeth with Carious Exposure. J Endod. 2018 Jun;44(6):932-937. doi: 10.1016/j.joen.2018.03.003. Epub 2018 Apr 19.
PubMed 29681479Vafaei A, Nikookhesal M, Erfanparast L, Lovschall H, Ranjkesh B. Vital pulp therapy following pulpotomy in immature first permanent molars with deep caries using novel fast-setting calcium silicate cement: A retrospective clinical study. J Dent. 2022 Jan;116:103890. doi: 10.1016/j.jdent.2021.103890. Epub 2021 Nov 12.
PubMed 34780875
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical and Radiographic Evaluation of Bioceramic Repair in Apexogenesis of Immature Permanent Molars
- ClinicalTrials.gov ID
- NCT07883239
- Acronym / sponsor ID
- # PED-4-24-2176
- Conditions
- Apexogenesis, Pulp Exposure, Dental, MTA Vital Tooth Pulpotomy, Cone Beam Computed Tomography
- Keywords
- Bioceramics, Apexogenesis, Immature Permanent Teeth, Root Development
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Tanta UniversityUniversity, hospital or other
- Study start
- 3 May 2024 (actual)
- Primary completion
- 5 Aug 2025 (actual)
- Study completion
- 4 May 2026 (actual)
- First posted
- 20 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.
The present study was conducted to compare the clinical, radiographic, and tomographic outcomes of apexogenesis using Bio-C Repair and Biofactor MTA in immature permanent first molars with vital asymptomatic pulp exposure.
Detailed description
Preservation of pulp vitality in immature permanent teeth is essential for continued root development and physiological apical closure. Apexogenesis is a conservative vital pulp therapy procedure that maintains the vitality of the radicular pulp, allowing continued root maturation, dentinal wall thickening, and strengthening of the tooth structure.
The present study was conducted to compare the clinical, radiographic, and tomographic outcomes of apexogenesis using Bio-C Repair and Biofactor MTA in immature permanent first molars with vital asymptomatic pulp exposure.
Thirty children aged 6-8 years presenting with bilateral deep carious lesions in immature permanent first molars requiring vital pulp therapy were enrolled in this split-mouth randomized clinical trial after obtaining informed parental consent. Only restorable teeth with vital pulps, no clinical signs or symptoms of irreversible pulp degeneration, and the ability to achieve hemostasis within a clinically acceptable period following pulp exposure were included.
Clinical and radiographic evaluations were performed at 6, 9, and 12 months postoperatively, while CBCT examinations were conducted before treatment and after 12 months to quantitatively assess root length, apical foramen diameter, and periapical bone density using region of interest (ROI) measurements.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group I - Study Group (Bioceramic Repair / BIO-C® REPAIR) | Experimental | Procedure: Bioceramic Repair Pulpotomy (BIO-C® REPAIR)Immature permanent first molars with vital exposed pulp undergoing apexogenesis (deep pulpotomy) using a ready-to-use premixed bioceramic repair material (BIO-C® REPAIR). |
| Group II - Control Group (Biofactor MTA) | Active comparator | Procedure: Mineral Trioxide Aggregate Pulpotomy (Biofactor MTA)Immature permanent first molars with vital exposed pulp undergoing apexogenesis (deep pulpotomy) using a powder-liquid mineral trioxide aggregate (Biofactor MTA). |
Who may qualify
- Ages
- 6 to 8 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (10 listed)
- Bilateral deep carious immature permanent first molars indicated for vital pulp therapy
- Vital teeth with no clinical signs or symptoms of irreversible pulpitis or pulp necrosis (Absence of spontaneous pain, tenderness to percussion or palpation, abnormal mobility and/ or soft tissue swelling, sinus tract, or fistula.)
- Teeth with restorable crowns.
- Hemostasis is achievable within a clinically acceptable period following pulp exposure.
- Absence of internal or external root resorption.
Key exclusion criteria (3 listed)
- presence of internal or external root resorption
- presence of periapical or furcal radiolucency.
- presence of widening of the periodontal ligament space
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 |
|---|---|---|
| Bioceramic Repair Pulpotomy (BIO-C® REPAIR)Pre-procedure \& Isolation: Pre-procedural 0.2% chlorhexidine mouthwash for 30 seconds; local anesthesia (4% Articaine with 1:100,000 epinephrine); rubber dam isolation. Surgical Procedure: Caries excavation and pulp chamber deroofing using a No. 330 bur; coronal pulp amputation using a sterile sharp excavator; irrigation with light saline flow; hemostasis achieved using a saline-moistened cotton pellet applied for 5 minutes. Material Placement: Ready-to-use BIO-C® REPAIR applied directly over the pulp stumps according to manufacturer instructions and adapted with a slightly moistened sterile cotton pellet. Restoration: Base layer sealed immediately with water-mixable glass ionomer cement (KROMOGLASS® 2) and restored with a nano-hybrid bulk-fill resin composite (Any-Com™ Nano Hybrid Bulk-Fill with One Coat Bond SL). | Procedure or surgery | Group I - Study Group (Bioceramic Repair / BIO-C® REPAIR) |
| Mineral Trioxide Aggregate Pulpotomy (Biofactor MTA)Pre-procedure \& Isolation: Identical pre-procedural rinse, local anesthesia administration, rubber dam isolation, caries excavation, coronal pulp amputation, saline irrigation, and 5-minute hemostasis protocol. Material Placement: Biofactor MTA powder and liquid mixed according to manufacturer instructions, applied directly over the pulp stumps, and adapted with a slightly moistened sterile cotton pellet. Restoration: Identical double-seal final restoration (glass ionomer base + nano-hybrid bulk-fill composite resin). | Procedure or surgery | Group II - Control Group (Biofactor MTA) |
Primary outcome
Clinical Success Rate
Time frame: Evaluated at 6, 9, and 12 months post-operative.
Clinical success evaluated binary (Success/Failure) at follow-up intervals based on the total absence of clinical signs and symptoms: Absence of spontaneous or persistent pain. Absence of tenderness to percussion. Absence of gingival inflammation surrounding the treated tooth. Absence of abscess, draining sinus tract, or pathological tooth mobility.
Radiographic Success Rate
Time frame: Evaluated at 6, 9, and 12 months post-operative.
Radiographic success evaluated binary (Success/Failure) via digital periapical radiographs based on standard endodontic criteria: Absence of periapical radiolucency or osteolytic lesions. Absence of internal or external root resorption. Absence of widening of the periodontal ligament space. Evidence of continued root development with progressive apical closure.
2 secondary outcomes
Quantitative Root Length Increase (CBCT)
Time frame: Measured at Baseline (immediate post-op) and 12 months post-operative.
Apical Foramen Diameter Reduction / Closure (CBCT)
Time frame: Measured at Baseline (immediate post-op) and 12 months post-operative.
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 20 Oct 2026.
- Results publication: PubMed 29681479Taha NA, Abdulkhader SZ. Full Pulpotomy with Biodentine in Symptomatic Young Permanent Teeth with Carious Exposure. J Endod. 2018 Jun;44(6):932-937. doi: 10.1016/j.joen.2018.03.003. Epub 2018 Apr 19.
- Results publication: PubMed 34780875Vafaei A, Nikookhesal M, Erfanparast L, Lovschall H, Ranjkesh B. Vital pulp therapy following pulpotomy in immature first permanent molars with deep caries using novel fast-setting calcium silicate cement: A retrospective clinical study. J Dent. 2022 Jan;116:103890. doi: 10.1016/j.jdent.2021.103890. Epub 2021 Nov 12.
Related trials for Apexogenesis
Active, not recruiting
Clinical Evaluation and Cone Beam Computed Tomography Analysis of Different Biomaterials for Apexogenesis of Immature Permanent Molars
Vital Pulp Therapy in Young Permanent Tooth
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bioceramic Repair Pulpotomy (BIO-C® REPAIR) and Mineral Trioxide Aggregate Pulpotomy (Biofactor MTA) in people with Apexogenesis and Pulp Exposure, Dental, run by Tanta 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 10 inclusion and 3 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 20 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?
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?
Clinical Success Rate (time frame: Evaluated at 6, 9, and 12 months post-operative.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07883239, which also lists 2 linked publications.
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 20 Oct 2026.