PulpotomyNCT06640205
Assessment of I-PRF Versus Nano MTA Combined with I-PRF Scaffold in Vital Pulp Therapy in Mature Mandibular First Molars
A study testing pulpotomy in people with Pulpotomy, run by Future University in Egypt at 1 site in Egypt.
Trial summary
Assessment of I-PRF versus Nano Mineral trioxide aggregate Combined with I-PRF in pulpotomy in mature Mandibular First Molars Read more about this study
- Who is it for?
- Ages 15 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Pulpotomy
- 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
- 51 participants
- Where
- 1 siteEgypt
- Study dates
- 3 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.
- The tooth is restorable
- 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.
Show all 9Show fewer
- 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 periapical lesions or infections.
- Pregnant females.
- Patients with fistula or swelling
- Patients with necrotic pulp.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Future university in egypt
Cairo, 11835
Abdelrahman Mo omar, Master, 01000424892 ext. 002, Abdelrahmanomar232@gmail.com
About this study
Official title: Clinical and Radiographic Assessment of I-PRF Versus Nano Mineral Trioxide Aggregate Combined with I-PRF Scaffold in Vital Pulp Therapy in Mandibular First Molars with Closed Apices: "Randomized Controlled Trial"
Assessment of I-PRF versus Nano Mineral trioxide aggregate Combined with I-PRF in pulpotomy in mature Mandibular First Molars
Read the detailed description
Clinical and Radiographic Assessment of I-PRF versus Nano Mineral trioxide aggregate Combined with I-PRF Scaffold in Vital Pulp Therapy in Mandibular First Molars with Closed Apices: "Randomized Controlled Trial"
- Conditions
- Pulpotomy
- 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 full pulpotomy, vital pulp therapy
Removal of coronal pulp tissue and then placing pulpotomy agent
| Study group | Role | What they receive |
|---|---|---|
| MTA Pulpotomy | Active comparator | using MTA as pulpotomy capping agent in mature permanent teeth Receives: Procedure: pulpotomy |
| I-PRF pulpotomy | Experimental | using I-PRF as pulpotomy capping agent in mature permanent teeth Receives: Procedure: pulpotomy |
| I-PRF combined with Nano MTA pulpotomy | Experimental | using nano MTA mixed with I-prf as pulpotomy capping agent in mature permanent teeth Receives: Procedure: pulpotomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post operative pain assessments
Pain assessments were made postoperatively with numerical rate scale. The scale includes scores from 0 to 10 where 0 indicates no pain , scores 1 to 3 indicates mild pain , scores 4 to 6 indicates moderate and scores 7 to 10 indicates severe pain.
Measured: 6 hours post operative , 12 hours post operative , 24h (one day) post operative , 72h (3 days ) post operative and 7 days (one week) post operative
Secondary outcomes (1)
Clinical and radiographic success
Clinically success : this includes that the tooth must be symptoms free ( No pain on percussion , no pain on biting and no pain with cold and hot ) . Also the tooth must not has any signs of failure as appearance of sinus tract or fistula during the follow up periods.
Radiographic success : this includes that the tooth did not develop a periapical radiolucency as periapical periodontitis .
Any deviation from the previous success criteria ( as clinical or radiographic ) considered as failure and the tooth will be shifted to root canal treatment.
Measured: 1 month post operative ,3 months clinical and radiograph ,6 months clinical and radiograph ,9 months clinical and radiograph and 12 months clinical and radiograph.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2024
- Study start3 Sep 2023
- Primary completion2 Sep 2024
- 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 PulpotomyStudies 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
- 51 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Future University in Egypt
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Abdelrahman Mohamed Elsayed Metwally Omar, Future University in Egypt
- Investigators
- Abdelrahman Mo Omar, Master, Study chair, Future University in Egypt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06640205
- Sponsor's protocol ID
- (32)/8-2023
- Status last verified
- Oct 2024
- First submitted
- 16 Aug 2024
- Last updated
- 15 Oct 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 15 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical and Radiographic Assessment of I-PRF Versus Nano Mineral Trioxide Aggregate Combined with I-PRF Scaffold in Vital Pulp Therapy in Mandibular First Molars with Closed Apices: "Randomized Controlled Trial"
- ClinicalTrials.gov ID
- NCT06640205
- Acronym / sponsor ID
- (32)/8-2023
- Conditions
- Pulpotomy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 51 participants (estimated)
- Lead sponsor
- Future University in EgyptUniversity, hospital or other
- Study start
- 3 Sep 2023 (actual)
- Primary completion
- 2 Sep 2024 (actual)
- Study completion
- 2 Sep 2025 (estimated)
- First posted
- 15 Oct 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.
Assessment of I-PRF versus Nano Mineral trioxide aggregate Combined with I-PRF in pulpotomy in mature Mandibular First Molars
Detailed description
Clinical and Radiographic Assessment of I-PRF versus Nano Mineral trioxide aggregate Combined with I-PRF Scaffold in Vital Pulp Therapy in Mandibular First Molars with Closed Apices: "Randomized Controlled Trial"
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| MTA Pulpotomy | Active comparator | Procedure: pulpotomyusing MTA as pulpotomy capping agent in mature permanent teeth |
| I-PRF pulpotomy | Experimental | Procedure: pulpotomyusing I-PRF as pulpotomy capping agent in mature permanent teeth |
| I-PRF combined with Nano MTA pulpotomy | Experimental | Procedure: pulpotomyusing nano MTA mixed with I-prf as pulpotomy capping agent in mature permanent teeth |
Who may qualify
- Ages
- 15 to 30 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.
Key exclusion criteria (6 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 |
|---|---|---|
| pulpotomyAlso: full pulpotomy, vital pulp therapyRemoval of coronal pulp tissue and then placing pulpotomy agent | Procedure or surgery | I-PRF combined with Nano MTA pulpotomy, I-PRF pulpotomy, MTA Pulpotomy |
Primary outcome
Post operative pain assessments
Time frame: 6 hours post operative , 12 hours post operative , 24h (one day) post operative , 72h (3 days ) post operative and 7 days (one week) post operative
Pain assessments were made postoperatively with numerical rate scale. The scale includes scores from 0 to 10 where 0 indicates no pain , scores 1 to 3 indicates mild pain , scores 4 to 6 indicates moderate and scores 7 to 10 indicates severe pain.
1 secondary outcome
Clinical and radiographic success
Time frame: 1 month post operative ,3 months clinical and radiograph ,6 months clinical and radiograph ,9 months clinical and radiograph and 12 months clinical and radiograph.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2024.
- Individual participant dataSharing planned: No
Related trials for Pulpotomy
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Short Term Comparative Assessment of MTA and Biodentine in Complete Pulpotomy for Symptomatic Irreversible Pulpitis
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Effect of Hemostatic Agents on TheraCal PT Pulpotomy Success in Primary Molars
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Pomegranate Peel Extract for Primary Molar Pulpotomy
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Evaluation of Pulpotomy Techniques (Formocresol, Ferric Sulphate, Mineral Trioxide Aggregate)
Periapical Healing
Active, not recruiting
Pain Assessment Governing Partial or Full Pulpotomy of Immature Molars With Irreversible Pulpitis in Molar Incisor Hypomineralization
Molar Incisor Hypomineralisation, Irreversible Pulpitis
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.
Abdelrahman Mo Omar, Master study chair
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 in people with Pulpotomy, 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 9 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 15 Oct 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 abdelrahman Mo Omar, Master (00201000424892 ext. 002, Abdulrahmanomar232@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 assessments (time frame: 6 hours post operative , 12 hours post operative , 24h (one day) post operative , 72h (3 days ) post operative and 7 days (one week) post operative). 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 15 Oct 2024.