Irreversible PulpitisNCT04784949
PRF Pulpotomy Using Different Bioceramic Materials in Permanent Molars
A study testing portland cement, Mineral trioxide aggregate and Biodentine in people with Irreversible Pulpitis, run by Fayoum University at 1 site in Egypt.
Trial summary
this study aimed to compare the clinical and radiographic outcomes of full pulpotmy after application of Biodentine, or MTA, or Portland cement above PRF membrane In permanent molars with irreversible pulpitis Read more about this study
- Who is it for?
- Ages 18 to 40 years
- Conditions the study is for
- Irreversible Pulpitis
- What is being tested?
- portland cement, Mineral trioxide aggregate and Biodentine
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Aug 2019to 1 Jan 2021
- 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 18 to 40 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- spontaneous, lingering pain exacerbated by hot and cold , and/or radiating pain
- Responded to cold and electric pulp testing
Who cannot join
- pain on palpation, percussion,
- mobility or swelling
- peridontall widening
- Teeth with marginal periodontitis or crestal bone loss
- resorption
- calcified canals
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Outcome of PRF Pulpotomy Using Different Bioceramic Materials in Permanent Molars With Irreversible Pulpitis: A Randomized Controlled Trial
this study aimed to compare the clinical and radiographic outcomes of full pulpotmy after application of Biodentine, or MTA, or Portland cement above PRF membrane In permanent molars with irreversible pulpitis
- Conditions
- Irreversible Pulpitis
- Being tested
- portland cement, Mineral trioxide aggregate, Biodentine
- Keywords
- PRF, Vital pulp therapy, pulpotomy, bioceramics
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
portland cementProcedure or surgery
pulpotomy with PRF and white Portland cement
Mineral trioxide aggregateProcedure or surgery
pulpotomy with PRF and white Mineral trioxide aggregate
BiodentineProcedure or surgery
pulpotomy with PRF and Biodentine
| Study group | Role | What they receive |
|---|---|---|
| Portland cement | Experimental | pulpotomy with PRF and white Portland cement Receives: Procedure: portland cement |
| Mineral trioxide aggregate | Experimental | pulpotomy with PRF and Mineral trioxide aggregate Receives: Procedure: Mineral trioxide aggregate |
| Biodentine | Experimental | pulpotomy with PRF and Biodentine Receives: Procedure: Biodentine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in postoperative pain
persistence , relief , or exacerbation of pain using visual analogue scale for pain score
Measured: 24 hours, 48 hours, 1 week, every 3 months for 12 months
Change in swelling
appearance of periapical swelling or facial swelling after the clinical procedures (Binary outcome: Yes/No)
Measured: 24 hours, 48 hours, 1 week, every 3 months for 12 months
Change in Mobility
appearance of teeth mobility after the clinical procedures (record of periodontal pocket depth)
Measured: 24 hours, 48 hours, 1 week, every 3 months for 12 months
Secondary outcomes (1)
calcific like bridge
measure of the calcific bridge thickness using CBCT
Measured: 12 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2021
- Study start1 Aug 2019
- Primary completion1 Aug 2020
- Study completion1 Jan 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- 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
- Model description
- permanent molar with symptomatic irreversible pulpitis
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fayoum University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Nageh, Fayoum University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04784949
- Sponsor's protocol ID
- PRF Pulp
- Status last verified
- Mar 2021
- First submitted
- 2 Mar 2021
- Last updated
- 5 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Asgary S, Eghbal MJ. Treatment outcomes of pulpotomy in permanent molars with irreversible pulpitis using biomaterials: a multi-center randomized controlled trial. Acta Odontol Scand. 2013 Jan;71(1):130-6. doi: 10.3109/00016357.2011.654251. Epub 2012 Feb 20.
PubMed 22339289Cushley S, Duncan HF, Lappin MJ, Tomson PL, Lundy FT, Cooper P, Clarke M, El Karim IA. Pulpotomy for mature carious teeth with symptoms of irreversible pulpitis: A systematic review. J Dent. 2019 Sep;88:103158. doi: 10.1016/j.jdent.2019.06.005. Epub 2019 Jun 20.
PubMed 31229496
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Outcome of PRF Pulpotomy Using Different Bioceramic Materials in Permanent Molars With Irreversible Pulpitis: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04784949
- Acronym / sponsor ID
- PRF Pulp
- Conditions
- Irreversible Pulpitis
- Keywords
- PRF, Vital pulp therapy, pulpotomy, bioceramics
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Fayoum UniversityUniversity, hospital or other
- Study start
- 1 Aug 2019 (actual)
- Primary completion
- 1 Aug 2020 (actual)
- Study completion
- 1 Jan 2021 (actual)
- First posted
- 5 Mar 2021 (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.
this study aimed to compare the clinical and radiographic outcomes of full pulpotmy after application of Biodentine, or MTA, or Portland cement above PRF membrane In permanent molars with irreversible pulpitis
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
- Model description
- permanent molar with symptomatic irreversible pulpitis
| Arm | Type | Receives |
|---|---|---|
| Portland cement | Experimental | Procedure: portland cementpulpotomy with PRF and white Portland cement |
| Mineral trioxide aggregate | Experimental | Procedure: Mineral trioxide aggregatepulpotomy with PRF and Mineral trioxide aggregate |
| Biodentine | Experimental | Procedure: Biodentinepulpotomy with PRF and Biodentine |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- spontaneous, lingering pain exacerbated by hot and cold , and/or radiating pain
- Responded to cold and electric pulp testing
Key exclusion criteria (6 listed)
- pain on palpation, percussion,
- mobility or swelling
- peridontall widening
- Teeth with marginal periodontitis or crestal bone loss
- resorption
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 |
|---|---|---|
| portland cementpulpotomy with PRF and white Portland cement | Procedure or surgery | Portland cement |
| Mineral trioxide aggregatepulpotomy with PRF and white Mineral trioxide aggregate | Procedure or surgery | Mineral trioxide aggregate |
| Biodentinepulpotomy with PRF and Biodentine | Procedure or surgery | Biodentine |
Primary outcome
Change in postoperative pain
Time frame: 24 hours, 48 hours, 1 week, every 3 months for 12 months
persistence , relief , or exacerbation of pain using visual analogue scale for pain score
Change in swelling
Time frame: 24 hours, 48 hours, 1 week, every 3 months for 12 months
appearance of periapical swelling or facial swelling after the clinical procedures (Binary outcome: Yes/No)
Change in Mobility
Time frame: 24 hours, 48 hours, 1 week, every 3 months for 12 months
appearance of teeth mobility after the clinical procedures (record of periodontal pocket depth)
1 secondary outcome
calcific like bridge
Time frame: 12 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2021.
- Background: PubMed 22339289Asgary S, Eghbal MJ. Treatment outcomes of pulpotomy in permanent molars with irreversible pulpitis using biomaterials: a multi-center randomized controlled trial. Acta Odontol Scand. 2013 Jan;71(1):130-6. doi: 10.3109/00016357.2011.654251. Epub 2012 Feb 20.
- Background: PubMed 31229496Cushley S, Duncan HF, Lappin MJ, Tomson PL, Lundy FT, Cooper P, Clarke M, El Karim IA. Pulpotomy for mature carious teeth with symptoms of irreversible pulpitis: A systematic review. J Dent. 2019 Sep;88:103158. doi: 10.1016/j.jdent.2019.06.005. Epub 2019 Jun 20.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing portland cement, Mineral trioxide aggregate and Biodentine in people with Irreversible Pulpitis, run by Fayoum 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 2 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: finished, as of the sponsor's last update on 5 Mar 2021. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in postoperative pain (time frame: 24 hours, 48 hours, 1 week, every 3 months for 12 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04784949, which also lists 2 linked publications.
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 5 Mar 2021.