Irreversible PulpitisNCT06613932
Assessment of L-PRF, Nanohydroxyapatite Combined With L-PRF Using Pulpotomy in Mature Mandibular First Molars
A study testing pulpotomy in people with Irreversible Pulpitis, run by Future University in Egypt at 1 site in Egypt.
Trial summary
Clinical and Radiographic Assessment of L-PRF, Nanohydroxyapatite material combined with L-PRF scaffold in Vital pulp Therapy. Treatments in Mandibular First Molars with Closed Apices, Randomized Controlled Trial. Read more about this study
- Who is it for?
- Ages 15 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Irreversible Pulpitis
- What is being tested?
- pulpotomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteEgypt
- Study dates
- 30 Oct 2023to 30 Oct 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 15 to 30 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Patients should be free from any systemic disease. Patients of either gender aged from 15-30. Patients will agree to the consent and will commit to a follow-up period. Soft tissues around the tooth are normal with no swelling or sinus tract. The tooth is restorable tooth has signs and symptoms of irreversible pulpitis of the mature root The tooth doesn\'t contain any internal or external resorption or periapical lesions.
- The tooth should give a positive response to the cold test.
Who cannot join
- Pregnant and lactating females. Patients with Mental disturbance. Patients who could/would not participate in a 6-month follow-up. A tooth with immature roots. Patients with necrotic pulp.• tooth with periapical lesions or infections. Soft tissue having fistula or swelling Homoeostasis after 10 minutes can not be controlled after total pulpotomy
Trial locations and contacts
1 site in 1 country.
toka A metwally, bachelor's contact
Egypt1 site, 1 recruiting
- Recruiting
future university in Egypt
Cairo, New Cairo, 11835
nada A metwally, master, 01122289353 ext. +02, nadaaymaan55@gmail.com
About this study
Official title: Clinical and Radiographic Assessment of L-PRF, Nanohydroxyapatite Material Combined With L-PRF Scaffold in Vital Pulp Therapy. Treatments in Mandibular First Molars With Closed Apices "Randomized Controlled Trial"
Clinical and Radiographic Assessment of L-PRF, Nanohydroxyapatite material combined with L-PRF scaffold in Vital pulp Therapy. Treatments in Mandibular First Molars with Closed Apices, Randomized Controlled Trial.
Read the detailed description
pulpotomy by using 3 materials. The first group(control group ) uses hydroxyapatite material as a pulpotomy agent, and the second group uses L-PRF as a pulpotomy agent. the third group uses combined material (L-PRF = Nano hydroxyapatite )as a pulpotomy agent .. then assesses the clinical and radiographic result of the 2 interventions group with control group
- Conditions
- Irreversible Pulpitis
- Being tested
- pulpotomy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pulpotomyProcedure or surgery
Also called vital pulp therapy
removal of the coronal pulp tissue and preservation of the radicular portion to ensure continuation of growth and vitality of tooth structure
| Study group | Role | What they receive |
|---|---|---|
| hydroxyapatite | Experimental | using hydroxyapatite as a pulpotomy agent and reviewing its clinical and radiographic performance compared to the other groups Receives: Procedure: pulpotomy |
| L-PRF | Experimental | using L-PRF as a pulpotomy agent and assessing the clinical and radiographic result compared to other groups Receives: Procedure: pulpotomy |
| L-PRF combined with Nano-hydroxyapatite | Experimental | using the combined material (nanohydroxyapatite mixed to L-PRF ) and assessing the clinical and radiographic result compared to other groups Receives: Procedure: pulpotomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
post operative Pain assessment
Pain evaluations were conducted preoperatively with numerical rating scale ( a verbal or writing determination of a pain level on a scale from 0 to 10, in which 0 represents no pain and 10 represents excruciating pain .
Measured: 6, 12, 24, 72hours and 7 days after treatment
Secondary outcomes (1)
Dentine bridge formation
evaluating the thickness of dentine bridge formed after the procedure by comparing immediate post operative CBCT with the one year follow up scans
Measured: 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 posted26 Sep 2024
- Study start30 Oct 2023
- Primary completion30 Oct 2024 (estimated)
- Study completion30 Oct 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Irreversible PulpitisStudies 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
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Future University in Egypt
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nada Ayman El-Sayed Ibraim, Future University in Egypt
- Investigators
- wael K hussein, professor, Study director, future
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06613932
- Sponsor's protocol ID
- (37)11-2023
- Status last verified
- Sep 2024
- First submitted
- 16 Aug 2024
- Last updated
- 26 Sep 2024
- Results posted
- No
- Data monitoring committee
- Yes
- 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 26 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical and Radiographic Assessment of L-PRF, Nanohydroxyapatite Material Combined With L-PRF Scaffold in Vital Pulp Therapy. Treatments in Mandibular First Molars With Closed Apices "Randomized Controlled Trial"
- ClinicalTrials.gov ID
- NCT06613932
- Acronym / sponsor ID
- (37)11-2023
- Conditions
- Irreversible Pulpitis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- Future University in EgyptUniversity, hospital or other
- Study start
- 30 Oct 2023 (actual)
- Primary completion
- 30 Oct 2024 (estimated)
- Study completion
- 30 Oct 2024 (estimated)
- First posted
- 26 Sep 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 L-PRF, Nanohydroxyapatite material combined with L-PRF scaffold in Vital pulp Therapy. Treatments in Mandibular First Molars with Closed Apices, Randomized Controlled Trial.
Detailed description
pulpotomy by using 3 materials. The first group(control group ) uses hydroxyapatite material as a pulpotomy agent, and the second group uses L-PRF as a pulpotomy agent. the third group uses combined material (L-PRF = Nano hydroxyapatite )as a pulpotomy agent .. then assesses the clinical and radiographic result of the 2 interventions group with control group
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| hydroxyapatite | Experimental | Procedure: pulpotomyusing hydroxyapatite as a pulpotomy agent and reviewing its clinical and radiographic performance compared to the other groups |
| L-PRF | Experimental | Procedure: pulpotomyusing L-PRF as a pulpotomy agent and assessing the clinical and radiographic result compared to other groups |
| L-PRF combined with Nano-hydroxyapatite | Experimental | Procedure: pulpotomyusing the combined material (nanohydroxyapatite mixed to L-PRF ) and assessing the clinical and radiographic result compared to other groups |
Who may qualify
- Ages
- 15 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- Patients should be free from any systemic disease. Patients of either gender aged from 15-30. Patients will agree to the consent and will commit to a follow-up period. Soft tissues around the tooth are normal with no swelling or sinus tract. The tooth is restorable tooth has signs and symptoms of irreversible pulpitis of the mature root The tooth doesn\'t contain any internal or external resorption or periapical lesions.
- The tooth should give a positive response to the cold test.
Key exclusion criteria (1 listed)
- Pregnant and lactating females. Patients with Mental disturbance. Patients who could/would not participate in a 6-month follow-up. A tooth with immature roots. Patients with necrotic pulp.• tooth with periapical lesions or infections. Soft tissue having fistula or swelling Homoeostasis after 10 minutes can not be controlled after total pulpotomy
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 |
|---|---|---|
| pulpotomyAlso: vital pulp therapyremoval of the coronal pulp tissue and preservation of the radicular portion to ensure continuation of growth and vitality of tooth structure | Procedure or surgery | L-PRF, L-PRF combined with Nano-hydroxyapatite, hydroxyapatite |
Primary outcome
post operative Pain assessment
Time frame: 6, 12, 24, 72hours and 7 days after treatment
Pain evaluations were conducted preoperatively with numerical rating scale ( a verbal or writing determination of a pain level on a scale from 0 to 10, in which 0 represents no pain and 10 represents excruciating pain .
1 secondary outcome
Dentine bridge formation
Time frame: 12 months post operative
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Sep 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.
toka A metwally, bachelor's contact
wael K hussein, professor study director
future
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 in people with Irreversible Pulpitis, 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 2 inclusion and 1 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 26 Sep 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 nada A metwally, master (01122289353 ext. +02, nadaaymaan55@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
post operative Pain assessment (time frame: 6, 12, 24, 72hours and 7 days after treatment). 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 26 Sep 2024.