Pulpitis - IrreversibleNCT06438523
A-prf,Nanochitosan Combined With A-prf Compared to Chitosan for Symptomatic Irreversible Pulpitis of Mature Teeth
A study testing PULPOTOMY OF MATURE PERMENANT TEETH in people with Pulpitis - Irreversible, run by Future University in Egypt at 1 site in Egypt.
Trial summary
Clinical and radiographic assessment of A-prf,A-prf combined with nanochitosan compared to chitosan for symptomatic irreversible pulpits in lower permanent first molar Read more about this study
- Who is it for?
- Ages 15 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Pulpitis - Irreversible
- What is being tested?
- PULPOTOMY OF MATURE PERMENANT TEETH
- 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
- 2 Sep 2023to 2 Sep 2025
- 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 15 to 30 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.
- Patients of either gender aged from 15-30.
- 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.
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- Patients who will agree to the consent and will commit to follow-up period.
- Patients with mature root.
- 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
Future university
Cairo, Fifth Settlement, 11813
Mai Sheriff Abdelwahed, Researcher
About this study
Official title: A-prf,Nanochitosan Combined With A-prf Scaffold Compared to Chitosan in Vital Pulp Therapy for Symptomatic Irreversible Pulpitis of Mature Permanent Mandibular First Molar Teeth .Randomized Controlled Trials
Clinical and radiographic assessment of A-prf,A-prf combined with nanochitosan compared to chitosan for symptomatic irreversible pulpits in lower permanent first molar
Read the detailed description
3 groups are allocated using : Aprf Aprf combined with nanochitosan Chitosan
Each group will be subjected to tests:
Tooth sensibility via EPT (electrical pulp tester)and thermal test Radiolucency in digital radiograph Pain in NRS(6-12-24-72h)for 1 week
- Conditions
- Pulpitis - Irreversible
- Being tested
- PULPOTOMY OF MATURE PERMENANT TEETH
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PULPOTOMY OF MATURE PERMENANT TEETHProcedure or surgery
Removal of coronal pulp and expose the orifices to apply the materials with aim to preserve vitality of remaining pulp
| Study group | Role | What they receive |
|---|---|---|
| Advanced Platelet rich fibrin,A-prf,A-PRF scaffold | Experimental | A-PRF will be prepared according to Choukroun's technique by drawing whole blood from the median cubital vein into a 10 ml plain plastic test tubes (non-citrated) without the addition of an anticoagulant reagent .
To prevent the blood from coagulating, it will be centrifuged immediately using a table top centrifuge at 1500 rpm for 14 minute. Receives: Procedure: PULPOTOMY OF MATURE PERMENANT TEETH |
| A-prf mixed with nano chitosan | Experimental | A-PRF will be prepared according to Choukroun's technique by drawing whole blood from the median cubital vein into a 10 ml plain plastic test tubes (non-citrated) without the addition of an anticoagulant reagent .
To prevent the blood from coagulating, it will be centrifuged immediately using a table top centrifuge at 1500 rpm for 14 minute then mixed with nanochitosan Receives: Procedure: PULPOTOMY OF MATURE PERMENANT TEETH |
| chitosan | Experimental | he access cavity will be prepared up to the level of pulp chamber floor using sterile round diamond bur size 1 in high-speed hand piece with coolant.Once the pulp has been reached, a sharp sterile excavator should be used to remove the pulp tissue to the level of the radicular/root canal orifices then chitosan will be applied Receives: Procedure: PULPOTOMY OF MATURE PERMENANT TEETH |
What is being measured
The primary outcome is the main question the study is designed to answer.
pain assessment
Pain assessment using numerical rate scale
Measured: 6,12,24,72hours and 7 days postoperative
Secondary outcomes (1)
Clinical and radiographic success
It includes clinical and radiographic success if either of them failed the case will considered failed.
Clinical failure :signs and symptoms of inflammation or infection Radiograph success and failure based on periapical index
Measured: 1,3,6,9and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2024
- Study start2 Sep 2023
- Primary completion2 May 2025 (estimated)
- Study completion2 Sep 2025 (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.
- 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
- Intervention: Intervention 1 : Vital pulp therapy using A-PRF as capping material. Intervention 2 : Vital pulp therapy using A-PRF mixed with Nano-Chitosan as capping material. Control/Comparator: Vital pulp therapy using Chitosan as capping material.
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Future University in Egypt
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mai Sherif, Future University in Egypt
- Investigators
- wael H Kamel, Prof., Study director, Future University in EgyptHani s sadek, Prof., Principal investigator, Future University in Egypt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06438523
- Sponsor's protocol ID
- 29
- Status last verified
- May 2024
- First submitted
- 15 May 2024
- Last updated
- 3 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- 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 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A-prf,Nanochitosan Combined With A-prf Scaffold Compared to Chitosan in Vital Pulp Therapy for Symptomatic Irreversible Pulpitis of Mature Permanent Mandibular First Molar Teeth .Randomized Controlled Trials
- ClinicalTrials.gov ID
- NCT06438523
- Acronym / sponsor ID
- 29
- Conditions
- Pulpitis - Irreversible
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Future University in EgyptUniversity, hospital or other
- Study start
- 2 Sep 2023 (actual)
- Primary completion
- 2 May 2025 (estimated)
- Study completion
- 2 Sep 2025 (estimated)
- First posted
- 3 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.
Clinical and radiographic assessment of A-prf,A-prf combined with nanochitosan compared to chitosan for symptomatic irreversible pulpits in lower permanent first molar
Detailed description
3 groups are allocated using : Aprf Aprf combined with nanochitosan Chitosan
Each group will be subjected to tests:
Tooth sensibility via EPT (electrical pulp tester)and thermal test Radiolucency in digital radiograph Pain in NRS(6-12-24-72h)for 1 week
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Intervention: Intervention 1 : Vital pulp therapy using A-PRF as capping material. Intervention 2 : Vital pulp therapy using A-PRF mixed with Nano-Chitosan as capping material. Control/Comparator: Vital pulp therapy using Chitosan as capping material.
| Arm | Type | Receives |
|---|---|---|
| Advanced Platelet rich fibrin,A-prf,A-PRF scaffold | Experimental | Procedure: PULPOTOMY OF MATURE PERMENANT TEETHA-PRF will be prepared according to Choukroun's technique by drawing whole blood from the median cubital vein into a 10 ml plain plastic test tubes (non-citrated) without the addition of an anticoagulant reagent . To prevent the blood from coagulating, it will be centrifuged immediately using a table top centrifuge at 1500 rpm for 14 minute. |
| A-prf mixed with nano chitosan | Experimental | Procedure: PULPOTOMY OF MATURE PERMENANT TEETHA-PRF will be prepared according to Choukroun's technique by drawing whole blood from the median cubital vein into a 10 ml plain plastic test tubes (non-citrated) without the addition of an anticoagulant reagent . To prevent the blood from coagulating, it will be centrifuged immediately using a table top centrifuge at 1500 rpm for 14 minute then mixed with nanochitosan |
| chitosan | Experimental | Procedure: PULPOTOMY OF MATURE PERMENANT TEETHhe access cavity will be prepared up to the level of pulp chamber floor using sterile round diamond bur size 1 in high-speed hand piece with coolant.Once the pulp has been reached, a sharp sterile excavator should be used to remove the pulp tissue to the level of the radicular/root canal orifices then chitosan will be applied |
Who may qualify
- Ages
- 15 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (10 listed)
- Patients suffering from Symptomatic irreversible pulpitis in mature mandibular molars only will be involved.
Key exclusion criteria (9 listed)
- Patients with immature roots.
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 |
|---|---|---|
| PULPOTOMY OF MATURE PERMENANT TEETHRemoval of coronal pulp and expose the orifices to apply the materials with aim to preserve vitality of remaining pulp | Procedure or surgery | A-prf mixed with nano chitosan, Advanced Platelet rich fibrin,A-prf,A-PRF scaffold, chitosan |
Primary outcome
pain assessment
Time frame: 6,12,24,72hours and 7 days postoperative
Pain assessment using numerical rate scale
1 secondary outcome
Clinical and radiographic success
Time frame: 1,3,6,9and 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2024.
- Individual participant dataSharing planned: No
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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.
wael H Kamel, Prof. study director
Future University in Egypt
Hani s sadek, Prof. principal investigator
Future University in Egypt
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PULPOTOMY OF MATURE PERMENANT TEETH in people with Pulpitis - Irreversible, run by Future University in Egypt 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 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 3 Jun 2024. 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 mai S abdelwahed, Bachelor (01068609957 ext. 01010604352, memo_141997@HOTMAIL.COM), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
pain assessment (time frame: 6,12,24,72hours and 7 days postoperative). 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 Jun 2024.