Pulpitis - IrreversibleNCT05726357
Pulpotomy vs Root Canal Treatment for Teeth With Symptomatic Irreversible Pulpitis
A study testing vital pulp therapy in people with Pulpitis - Irreversible, run by British University In Egypt at 1 site in Egypt.
Trial summary
high-quality evidence is needed to add to current knowledge and also assess the long-term outcomes for full/complete pulpotomy after carious pulpal exposure in patients with signs and symptoms indicative of irreversible pulpitis Read more about this study
- Who is it for?
- Ages 12 years and olderHealthy volunteers can take part
- Conditions the study is for
- Pulpitis - Irreversible
- What is being tested?
- vital pulp therapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 380 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Apr 2023to 30 Nov 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 12 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- a mature permanent tooth
- symptoms indicative of IRP
- responsive to cold and EPT sensibility testing
- restorable and can be adequately isolated during treatment
- One tooth (molar or premolar) per patient.
Who cannot join
- active periodontal disease
- complex medical histories
- unable to consent
- pregnant or breast-feeding
- excessive bleeding that cannot be controlled
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Faculty of Dentistry
Cairo, 11837
shehabeldin mohamed saber, phd, +201001413734, shehabeldin.saber@bue.edu.eg
dalia ghalwash, phd, +201005120159, dalia.ghalwash@bue.edu.eg
About this study
Official title: Pulpotomy vs Root Canal Treatment for Teeth With Symptomatic Irreversible Pulpitis: A Randomised Control Trial
high-quality evidence is needed to add to current knowledge and also assess the long-term outcomes for full/complete pulpotomy after carious pulpal exposure in patients with signs and symptoms indicative of irreversible pulpitis
- Conditions
- Pulpitis - Irreversible
- Being tested
- vital pulp therapy
- Keywords
- vital pulp therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
vital pulp therapyProcedure or surgery
removal of the coronal pulp followed by placing a biocompatible material to preserve the vitality of the radicular pulp
| Study group | Role | What they receive |
|---|---|---|
| standard root canal treatment | Active comparator | standard root canal treatment Receives: Procedure: vital pulp therapy |
| Pulpotomy | Active comparator | vital pulp therapy Receives: Procedure: vital pulp therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
pain score
score by a numeric rating scale from 1(minimum pain) to 100 (maximum pain)
Measured: day 3 post treatment
Secondary outcomes (1)
pain score
score by a numeric rating scale from 1(minimum pain) to 100 (maximum pain)
Measured: 6 months post treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2023
- Study start1 Apr 2023
- Primary completion31 Mar 2024 (estimated)
- Study completion30 Nov 2024 (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
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 380 participants (estimated)
Sponsor and investigators
- Lead sponsor
- British University In Egypt
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, shehabeldin saber, British University In Egypt
- Investigators
- shehabeldin Saber, Principal investigator, Professor of Endodontics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05726357
- Sponsor's protocol ID
- FD BUE REC 22-034
- Status last verified
- Aug 2023
- First submitted
- 1 Feb 2023
- Last updated
- 3 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: not to be shared
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pulpotomy vs Root Canal Treatment for Teeth With Symptomatic Irreversible Pulpitis: A Randomised Control Trial
- ClinicalTrials.gov ID
- NCT05726357
- Acronym / sponsor ID
- FD BUE REC 22-034
- Conditions
- Pulpitis - Irreversible
- Keywords
- vital pulp therapy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 380 participants (estimated)
- Lead sponsor
- British University In EgyptUniversity, hospital or other
- Study start
- 1 Apr 2023 (actual)
- Primary completion
- 31 Mar 2024 (estimated)
- Study completion
- 30 Nov 2024 (estimated)
- First posted
- 13 Feb 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.
high-quality evidence is needed to add to current knowledge and also assess the long-term outcomes for full/complete pulpotomy after carious pulpal exposure in patients with signs and symptoms indicative of irreversible pulpitis
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| standard root canal treatment | Active comparator | Procedure: vital pulp therapystandard root canal treatment |
| Pulpotomy | Active comparator | Procedure: vital pulp therapyvital pulp therapy |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- a mature permanent tooth
- symptoms indicative of IRP
- responsive to cold and EPT sensibility testing
- restorable and can be adequately isolated during treatment
- One tooth (molar or premolar) per patient.
Key exclusion criteria (5 listed)
- active periodontal disease
- complex medical histories
- unable to consent
- pregnant or breast-feeding
- excessive bleeding that cannot be controlled
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 |
|---|---|---|
| vital pulp therapyremoval of the coronal pulp followed by placing a biocompatible material to preserve the vitality of the radicular pulp | Procedure or surgery | Pulpotomy, standard root canal treatment |
Primary outcome
pain score
Time frame: day 3 post treatment
score by a numeric rating scale from 1(minimum pain) to 100 (maximum pain)
1 secondary outcome
pain score
Time frame: 6 months post treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2023.
- Individual participant dataSharing planned: Undecided. not to be shared
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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.
shehabeldin Saber principal investigator
Professor of Endodontics
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing vital pulp therapy in people with Pulpitis - Irreversible, run by British 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 5 inclusion and 5 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 Aug 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 Shehabeldin Saber, phD (+202 26890000 ext. 1065, shehabeldin.saber@bue.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
pain score (time frame: day 3 post 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 3 Aug 2023.