PulpitisNCT06468085
Evaluation of Pulpotomy Using Two Different Agents in Mature Anterior Teeth With Pulpitis
A study testing premixed Bioceramic NeoPUTTY®, Biodentine™ and Root canal treatment in people with Pulpitis, run by Ain Shams University.
Trial summary
the study will evaluate the clinical and radiological success of mature permanent anterior teeth pulpotomy in children and adolescents with signs of pulpitis using two different Biomimetic materials (NeoPutty® and Biodentine™) as a pulp dressing material in comparison to root canal treatment at 3, 6, 9 and 12 months… Read more about this study
- Who is it for?
- Ages 9 to 14 yearsHealthy volunteers can take part
- Conditions the study is for
- Pulpitis
- What is being tested?
- premixed Bioceramic NeoPUTTY®, Biodentine™ and Root canal treatment
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- No sites listed yet
- Study dates
- 1 Jul 2024to 1 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 9 to 14 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Children and adolescents of both sexes aged between 9 and 14 years old.
- Vital mature permanent anterior teeth with deep caries lesions that approach the pulp with signs of pulpitis and respond positive to cold pulp testing.
- Vital mature permanent anterior teeth with pulpal exposure that occurred during caries excavation.
- Patients presented immediately after suffering recent trauma (at the same day) to mature anterior teeth that had resulted in a crown fracture with pulp exposure.
Who cannot join
- Teeth with signs of infection such as swelling, sinus tract or pathological mobility or excessive mobility.
- Teeth with excessive bleeding from amputated radicular stumps
- Teeth showing radiographic evidence of pathologic root resorption, periapical pathology and calcifications in the canals.
- Lack of patient/parent compliance and cooperation.
- Children who are physically or mentally disabled or having any medical condition that will complicate the treatment.
- Patients allergic to any medicaments used.
Trial locations and contacts
No sites are listed yet.
Dina Darwish, BDS,MSc, MD contact
About this study
Official title: Clinical and Radiographic Evaluation of Premixed Bioceramic Putty and Biodentine™ Pulpotomy in Mature Permanent Anterior Teeth With Signs of Pulpitis: A Randomized Controlled Trial
the study will evaluate the clinical and radiological success of mature permanent anterior teeth pulpotomy in children and adolescents with signs of pulpitis using two different Biomimetic materials (NeoPutty® and Biodentine™) as a pulp dressing material in comparison to root canal treatment at 3, 6, 9 and 12 months follow up.
Read the detailed description
In this randomized controlled trial, A total number of 75 mature vital permanent anterior teeth with recent trauma or deep caries in children aged between 9 and 14 years will be included. Patients will be randomly allocated into three study groups: group A (premixed bioceramic NeoPutty®) test group, group B (Biodentine™) test group and group C (root canal treatment) control group. Cases will be evaluated clinically and radiographically to obtain baseline data. Local anesthesia will be administered and then rubber dam isolation will be performed. Pulpotomy procedure will be performed after hemostasis followed by covering pulp stump with Premixed Bioceramic or Biodentine™ according to the corresponding group then final composite restoration will be applied. Root canal treatment will be performed to the control group followed by composite restoration. Blinded clinical evaluation will be done at baseline, 3, 6, 9 and 12 months.
- Conditions
- Pulpitis
- Being tested
- premixed Bioceramic NeoPUTTY®, Biodentine™, Root canal treatment
- Medical subject headings
- Pulpitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
premixed Bioceramic NeoPUTTY®Procedure or surgery
Pulpotomy procedure will be performed after hemostasis followed by covering pulp stump with Premixed Bioceramic then final composite restoration will be applied. clinical evaluation will be done at baseline, 3, 6, 9 and 12 months.
Biodentine™Procedure or surgery
Pulpotomy procedure will be performed after hemostasis followed by covering pulp stump with Premixed Bioceramic or Biodentine™ according to the corresponding group then final composite restoration will be applied. clinical evaluation will be done at baseline, 3, 6, 9 and 12 months.
Root canal treatmentProcedure or surgery
Root canal treatment will be performed to the control group followed by composite restoration. clinical evaluation will be done at baseline, 3, 6, 9 and 12 months.
| Study group | Role | What they receive |
|---|---|---|
| Group A: The premixed Bioceramic NeoPUTTY® group | Experimental | Cases will be evaluated clinically and radiographically to obtain baseline data. Local anesthesia will be administered and then rubber dam isolation will be performed. Pulpotomy procedure will be performed after hemostasis followed by covering pulp stump with Premixed Bioceramic NeoPUTTY® then final composite restoration will be applied. Receives: Procedure: premixed Bioceramic NeoPUTTY® |
| Group B: The Biodentine™ group | Experimental | Cases will be evaluated clinically and radiographically to obtain baseline data. Local anesthesia will be administered and then rubber dam isolation will be performed. Pulpotomy procedure will be performed after hemostasis followed by covering pulp stump with Biodentine™ then final composite restoration will be applied. Receives: Procedure: Biodentine™ |
| Group C: the root canal treatment group | Active comparator | Root canal treatment will be performed to the control group followed by composite restoration. Receives: Procedure: Root canal treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical success
Absence of pain related to the treated teeth, including patient reported pain or sensitivity to percussion/palpation.
No evidence of swelling of supporting soft tissue or presence of sinus tract. Absence of excessive mobility affecting treated teeth.
Measured: 3, 6, 9 and 12 months follow up
Radiographic success
No Internal or external root resorption. No Periapical radiolucency.
Measured: 3, 6, 9 and 12 months follow up
Secondary outcomes (1)
Evaluation of tooth discoloration.
Evaluation of tooth discoloration using the VITA Easyshade V digital spectrophotometer.
Measured: 3, 6, 9 and 12 months follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2024
- Study start1 Jul 2024 (estimated)
- Primary completion1 Jan 2026 (estimated)
- Study completion1 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PulpitisStudies of the same condition, open and under way.
- More trials run by Ain Shams 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
- Model description
- two study groups and one control group
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sally Emad Nathan Ghobrial, Ain Shams University
- Investigators
- Nagwa Khattab, BDS,MSc, MD, Study director, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06468085
- Sponsor's protocol ID
- FDASU-Rec ID032421
- Status last verified
- Jun 2024
- First submitted
- 15 Jun 2024
- Last updated
- 21 Jun 2024
- 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 21 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical and Radiographic Evaluation of Premixed Bioceramic Putty and Biodentine™ Pulpotomy in Mature Permanent Anterior Teeth With Signs of Pulpitis: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06468085
- Acronym / sponsor ID
- FDASU-Rec ID032421
- Conditions
- Pulpitis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 1 Jul 2024 (estimated)
- Primary completion
- 1 Jan 2026 (estimated)
- Study completion
- 1 Jul 2026 (estimated)
- First posted
- 21 Jun 2024 (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 study will evaluate the clinical and radiological success of mature permanent anterior teeth pulpotomy in children and adolescents with signs of pulpitis using two different Biomimetic materials (NeoPutty® and Biodentine™) as a pulp dressing material in comparison to root canal treatment at 3, 6, 9 and 12 months follow up.
Detailed description
In this randomized controlled trial, A total number of 75 mature vital permanent anterior teeth with recent trauma or deep caries in children aged between 9 and 14 years will be included. Patients will be randomly allocated into three study groups: group A (premixed bioceramic NeoPutty®) test group, group B (Biodentine™) test group and group C (root canal treatment) control group. Cases will be evaluated clinically and radiographically to obtain baseline data. Local anesthesia will be administered and then rubber dam isolation will be performed. Pulpotomy procedure will be performed after hemostasis followed by covering pulp stump with Premixed Bioceramic or Biodentine™ according to the corresponding group then final composite restoration will be applied. Root canal treatment will be performed to the control group followed by composite restoration. Blinded clinical evaluation will be done at baseline, 3, 6, 9 and 12 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
- Model description
- two study groups and one control group
| Arm | Type | Receives |
|---|---|---|
| Group A: The premixed Bioceramic NeoPUTTY® group | Experimental | Procedure: premixed Bioceramic NeoPUTTY®Cases will be evaluated clinically and radiographically to obtain baseline data. Local anesthesia will be administered and then rubber dam isolation will be performed. Pulpotomy procedure will be performed after hemostasis followed by covering pulp stump with Premixed Bioceramic NeoPUTTY® then final composite restoration will be applied. |
| Group B: The Biodentine™ group | Experimental | Procedure: Biodentine™Cases will be evaluated clinically and radiographically to obtain baseline data. Local anesthesia will be administered and then rubber dam isolation will be performed. Pulpotomy procedure will be performed after hemostasis followed by covering pulp stump with Biodentine™ then final composite restoration will be applied. |
| Group C: the root canal treatment group | Active comparator | Procedure: Root canal treatmentRoot canal treatment will be performed to the control group followed by composite restoration. |
Who may qualify
- Ages
- 9 to 14 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Children and adolescents of both sexes aged between 9 and 14 years old.
- Vital mature permanent anterior teeth with deep caries lesions that approach the pulp with signs of pulpitis and respond positive to cold pulp testing.
- Vital mature permanent anterior teeth with pulpal exposure that occurred during caries excavation.
- Patients presented immediately after suffering recent trauma (at the same day) to mature anterior teeth that had resulted in a crown fracture with pulp exposure.
Key exclusion criteria (6 listed)
- Teeth with signs of infection such as swelling, sinus tract or pathological mobility or excessive mobility.
- Teeth with excessive bleeding from amputated radicular stumps
- Teeth showing radiographic evidence of pathologic root resorption, periapical pathology and calcifications in the canals.
- Lack of patient/parent compliance and cooperation.
- Children who are physically or mentally disabled or having any medical condition that will complicate the 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 |
|---|---|---|
| premixed Bioceramic NeoPUTTY®Pulpotomy procedure will be performed after hemostasis followed by covering pulp stump with Premixed Bioceramic then final composite restoration will be applied. clinical evaluation will be done at baseline, 3, 6, 9 and 12 months. | Procedure or surgery | Group A: The premixed Bioceramic NeoPUTTY® group |
| Biodentine™Pulpotomy procedure will be performed after hemostasis followed by covering pulp stump with Premixed Bioceramic or Biodentine™ according to the corresponding group then final composite restoration will be applied. clinical evaluation will be done at baseline, 3, 6, 9 and 12 months. | Procedure or surgery | Group B: The Biodentine™ group |
| Root canal treatmentRoot canal treatment will be performed to the control group followed by composite restoration. clinical evaluation will be done at baseline, 3, 6, 9 and 12 months. | Procedure or surgery | Group C: the root canal treatment group |
Primary outcome
Clinical success
Time frame: 3, 6, 9 and 12 months follow up
Absence of pain related to the treated teeth, including patient reported pain or sensitivity to percussion/palpation. No evidence of swelling of supporting soft tissue or presence of sinus tract. Absence of excessive mobility affecting treated teeth.
Radiographic success
Time frame: 3, 6, 9 and 12 months follow up
No Internal or external root resorption. No Periapical radiolucency.
1 secondary outcome
Evaluation of tooth discoloration.
Time frame: 3, 6, 9 and 12 months follow up
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jun 2024.
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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. This study is not recruiting at the moment.
Dina Darwish, BDS,MSc, MD contact
Nagwa Khattab, BDS,MSc, MD study director
Ain Shams University
Questions about this trial
What is this clinical trial studying?
A study testing premixed Bioceramic NeoPUTTY®, Biodentine™ and Root canal treatment in people with Pulpitis, run by Ain Shams 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 4 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 21 Jun 2024. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sally Emad, BDS,MSc (01227788137, sallyghobrial@dent.asu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical success (time frame: 3, 6, 9 and 12 months follow up). 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?
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 21 Jun 2024.