Vital Pulp Treatment in Mature Permanent Teeth With Irreversible PulpitisI-PRFNCT05876520
Clinical and Radiographic Assessment of Nano-Bioactive Glass Combined With I-PRF Scaffold in Vital Pulp Treatments in Mandibular Molars With Closed Apices
A study testing Total pulpotomy with I-prf mixed with Nano-bioactive glass in people with Vital Pulp Treatment in Mature Permanent Teeth With Irreversible Pulpitis, run by Cairo University at 1 site in Egypt.
Trial summary
Clinical, Radiographic and pain assessment of Vital pulp treatment in patients suffering from irreversible pulpitis in mature permanent molars. Total pulpotomy is investigated using I-prf only vs I-prf mixed with Nano-bioactive glass. Read more about this study
- Who is it for?
- Ages 14 to 32 yearsHealthy volunteers can take part
- Conditions the study is for
- Vital Pulp Treatment in Mature Permanent Teeth With Irreversible Pulpitis
- What is being tested?
- Total pulpotomy with I-prf mixed with Nano-bioactive glass
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteEgypt
- Study dates
- 25 Jan 2023to Apr 2024
- 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 14 to 32 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Patients suffering from Symptomatic irreversible pulpitis in mature mandibular molars only will be involved.
- Tooth should give positive response to cold test
- Haemostasias should be achieved after total pulpotomy
- The tooth is restorable and free from advanced periodontal disease, cracks and splits.
- 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.
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- Patients with mature root apices
- Patients with no internal or external resorption and no periapical lesions
- Soft tissues around the tooth are normal with no swelling or sinus tract.
Who cannot join
- Patients with immature roots.
- Haemostasias after 10 minutes can not be controlled after total pulpotomy
- Patients with any systemic disease that may affect normal healing.
- Patients with periapical lesions or infections.
- Pregnant females.
- Patients who could/would not participate in a 6 months follow-up.
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- Patients with fistula or swelling
- Patients with necrotic pulp.
- Patients with old age.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Noor Mohammed Kamal Eldeen
Cairo
Noor K. Sayed, 00201121818177, noor.kamal@dentistry.cu.edu.eg
Noor K. Sayed, 00201121818177, noor.m.kamal35@gmail.com
About this study
Official title: Clinical and Radiographic Assessment of Nano-Bioactive Glass Combined With I-PRF Scaffold in Vital Pulp Treatments in Mandibular Molars With Closed Apices: A Triple Blinded "Randomized Controlled Trial"
Clinical, Radiographic and pain assessment of Vital pulp treatment in patients suffering from irreversible pulpitis in mature permanent molars. Total pulpotomy is investigated using I-prf only vs I-prf mixed with Nano-bioactive glass.
- Being tested
- Total pulpotomy with I-prf mixed with Nano-bioactive glass
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Total pulpotomy with I-prf mixed with Nano-bioactive glassProcedure or surgery
Total pulpotomy is done in mature permanent molars followed by I-prf mixed with Nano-Bioactive glass application. Topped with BC putty for coronal seal, RMGI and restored with composite as final restoration
| Study group | Role | What they receive |
|---|---|---|
| Total pulpotomy with I-PRF only | Other | Total pulpotomy is done in mature permanent molars followed by I-prf application. Topped with BC putty for coronal seal, RMGI and restored with composite as final restoration Receives: Procedure: Total pulpotomy with I-prf mixed with Nano-bioactive glass |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical , Radiographic and Success rate
Presence or absence of clinical signs and symptoms + Radiographic periapical assessment + success rate based on Radiographic findings
Measured: 6 month follow up
Secondary outcomes (1)
Pain intensity
VAS used to record daily pain intensity
Measured: Within the first 24 hrs upto the 7th day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2023
- Study start25 Jan 2023
- Primary completionMar 2024 (estimated)
- Study completionApr 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vital Pulp Treatment in Mature Permanent Teeth With Irreversible PulpitisStudies 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
- Not applicable
- Intervention model
- Single group
- Model description
- Total Pulpotomy in mature permanent teeth treated with Nano-bioactive glass mixed with I-PRF
- Masking
- None (open label)
- Enrolment
- 28 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Noor Mohammed Kamal Eldeen Ahmed Mohmammed Sayed, Cairo University
- Investigators
- Geraldine Ahmed, Study director, Vice Dean of Faculty of Dentistry Cairo UniversityAhmed S. Elsheshtawy, Study chair, Lecturer of EndodonticsAyah Abdolwahab, Study chair, Lecturer of BiomaterialsNoor K. Sayed, Principal investigator, Resident of Endodontics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05876520
- Sponsor's protocol ID
- ENDO-3-7-2
- Acronym
- I-PRF
- Status last verified
- May 2023
- First submitted
- 9 May 2023
- Last updated
- 25 May 2023
- 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 25 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical and Radiographic Assessment of Nano-Bioactive Glass Combined With I-PRF Scaffold in Vital Pulp Treatments in Mandibular Molars With Closed Apices: A Triple Blinded "Randomized Controlled Trial"
- ClinicalTrials.gov ID
- NCT05876520
- Acronym / sponsor ID
- I-PRF / ENDO-3-7-2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 28 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 25 Jan 2023 (actual)
- Primary completion
- Mar 2024 (estimated)
- Study completion
- Apr 2024 (estimated)
- First posted
- 25 May 2023 (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.
Clinical, Radiographic and pain assessment of Vital pulp treatment in patients suffering from irreversible pulpitis in mature permanent molars. Total pulpotomy is investigated using I-prf only vs I-prf mixed with Nano-bioactive glass.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Total Pulpotomy in mature permanent teeth treated with Nano-bioactive glass mixed with I-PRF
| Arm | Type | Receives |
|---|---|---|
| Total pulpotomy with I-PRF only | Other | Procedure: Total pulpotomy with I-prf mixed with Nano-bioactive glassTotal pulpotomy is done in mature permanent molars followed by I-prf application. Topped with BC putty for coronal seal, RMGI and restored with composite as final restoration |
Who may qualify
- Ages
- 14 to 32 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (9 listed)
- Patients suffering from Symptomatic irreversible pulpitis in mature mandibular molars only will be involved.
- Tooth should give positive response to cold test
- Haemostasias should be achieved after total pulpotomy
- The tooth is restorable and free from advanced periodontal disease, cracks and splits.
- Patients should be free from any systemic disease that may affect normal healing and predictable outcome.
Key exclusion criteria (9 listed)
- Patients with immature roots.
- Haemostasias after 10 minutes can not be controlled after total pulpotomy
- Patients with any systemic disease that may affect normal healing.
- Patients with periapical lesions or infections.
- Pregnant females.
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 |
|---|---|---|
| Total pulpotomy with I-prf mixed with Nano-bioactive glassTotal pulpotomy is done in mature permanent molars followed by I-prf mixed with Nano-Bioactive glass application. Topped with BC putty for coronal seal, RMGI and restored with composite as final restoration | Procedure or surgery | Total pulpotomy with I-PRF only |
Primary outcome
Clinical , Radiographic and Success rate
Time frame: 6 month follow up
Presence or absence of clinical signs and symptoms + Radiographic periapical assessment + success rate based on Radiographic findings
1 secondary outcome
Pain intensity
Time frame: Within the first 24 hrs upto the 7th day
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 May 2023.
Related trials for Vital Pulp Treatment in Mature Permanent Teeth With Irreversible Pulpitis
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Evaluation of the Success Rate of Pulpotomy Versus to Root Canal Therapy in Management of Mature First Permanent Molars With Irreversible Pulpitis
Irreversible Pulpitis (Toothache), Dental Caries (Diagnosis)
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.
Geraldine Ahmed study director
Vice Dean of Faculty of Dentistry Cairo University
Ahmed S. Elsheshtawy study chair
Lecturer of Endodontics
Ayah Abdolwahab study chair
Lecturer of Biomaterials
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Total pulpotomy with I-prf mixed with Nano-bioactive glass in people with Vital Pulp Treatment in Mature Permanent Teeth With Irreversible Pulpitis, run by Cairo 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 9 inclusion and 9 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 25 May 2023. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Noor K. Sayed (00201121818177, noor.kamal@dentistry.cu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical , Radiographic and Success rate (time frame: 6 month follow up). 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 25 May 2023.