Symptomatic Irreversible Pulpitis (SIP)NCT07483788
Short Term Comparative Assessment of MTA and Biodentine in Complete Pulpotomy for Symptomatic Irreversible Pulpitis
A study testing Biodentine pulpotomy in people with Symptomatic Irreversible Pulpitis (SIP), run by Dow University of Health Sciences at 2 sites in Pakistan.
Trial summary
All Patients coming to the Operative Dentistry Department (DIDC-DUHS) with complain of pain in posterior teeth will be invited to participate. The treatment will be done by one dentist. Read more about this study
- Who is it for?
- Ages 18 to 40 years
- Conditions the study is for
- Symptomatic Irreversible Pulpitis (SIP)
- What is being tested?
- Biodentine pulpotomy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 2 sitesPakistan
- Study dates
- 2 Nov 2024to 30 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Teeth of generally healthy patients having following criteria will be included:
- Age between 18-40 years of both males and females
- Carious exposed maxillary and mandibular molars teeth
- Moderate to severe pain (VAS 4-10)
- Diagnosed with Symptomatic irreversible pulpitis on cold test and Electric pulp test (EPT)
- Periapical index of 1
- Hemostasis is achieved within 10 mins after full pulpotomy
Who cannot join
- Teeth of generally healthy patients having following criteria will be excluded:
- Any traumatic injury
- Non-restorable carious lesion
- Immature or Open apices of roots
- Internal or external Resorption
- Calcified canals
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Pakistan2 sites, 2 recruiting
- Recruiting
Dr Khadija Zubair
Karachi, Sindh
Dr Khadija Zubair, Postgraduate trainee- FCPS, 03363605145, khadijazubair.2823578@duhs.edu.pk
Dr Khadija Zubair, Postgraduate Trainee- FCPS
- Recruiting
Dr Khadija Zubair
Karachi, Sindh
About this study
Official title: Short Term Outcome of Complete Pulpotomy Using MTA vs Biodentine in Symptomatic Irreversible Pulpitis - A Randomized Controlled Trial
All Patients coming to the Operative Dentistry Department (DIDC-DUHS) with complain of pain in posterior teeth will be invited to participate. The treatment will be done by one dentist. Patient's medical and dental history will be recorded, and tooth will be checked for swelling, sensitivity, cavity type, and loosening of tooth. Special tests like the cold test, electric pulp test, and an X-ray will help assess the tooth's condition. Patient will also be asked to rate pain from 1-10. Before starting the treatment, the procedure will be explained to patient in detail, and written consent will be taken. The treatment will be done in two visits by one dentist. Patient will be given an injection to make tooth pain-free so that patient does not feel any discomfort during the treatment and the area will be kept clean using a rubber sheet. The dentist will remove the hole in tooth and remove the infected soft part of tooth and stop the bleeding. Then one of the two materials will be placed inside the tooth. A temporary filling will be placed first, and patient will come the next day for the final filling. An X-ray will be taken to check the result. If patient feel pain, may take ibuprofen (400 mg) as needed, and if the pain continues, please contact the dentist. Patient will be called for follow-ups after 1 day, 1 week, 1 month, and 3 months to make sure the tooth is healing properly.
- Conditions
- Symptomatic Irreversible Pulpitis (SIP)
- Being tested
- Biodentine pulpotomy
- Keywords
- Symptomatic Irreversible Pulpitis, Complete pulpotomy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biodentine pulpotomyOther
Pulpotomy performed using Mineral Trioxide Aggregate (MTA)
| Study group | Role | What they receive |
|---|---|---|
| MTA | Experimental | Pulpotomy material MTA Receives: Other: Biodentine pulpotomy |
| Biodentine | Experimental | Pulpotomy material Biodentine Receives: Other: Biodentine pulpotomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Short term outcome of complete pulpotomy using MTA vs Biodentine in Symptomatic Irreversible Pulpitis- A Randomized Controlled Trial
Clinical outcome measure through Electric pulp testing (EPT) and radiographic outcome measure through Periapical index (PAI)
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2026
- Study start2 Nov 2024
- Primary completion30 Nov 2026 (estimated)
- Study completion30 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Symptomatic Irreversible Pulpitis (SIP)Studies 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
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dow University of Health Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Khadija Zubair, Dow University of Health Sciences
- Investigators
- Dr Khadija Zubair, Postgraduate Trainee- FCPS, Principal investigator, Dow University of Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07483788
- Sponsor's protocol ID
- IRB-3724/DUHS/Approval/2024/92
- Status last verified
- Oct 2026
- First submitted
- 28 Nov 2025
- Last updated
- 20 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: IPD will not be shared outside the study team to ensure patient confidentiality and privacy. Data will be used only for the purposes of this study and will remain restricted to the research team
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Short Term Outcome of Complete Pulpotomy Using MTA vs Biodentine in Symptomatic Irreversible Pulpitis - A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07483788
- Acronym / sponsor ID
- IRB-3724/DUHS/Approval/2024/92
- Conditions
- Symptomatic Irreversible Pulpitis (SIP)
- Keywords
- Symptomatic Irreversible Pulpitis, Complete pulpotomy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Dow University of Health SciencesUniversity, hospital or other
- Study start
- 2 Nov 2024 (actual)
- Primary completion
- 30 Nov 2026 (estimated)
- Study completion
- 30 Dec 2026 (estimated)
- First posted
- 19 Mar 2026 (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.
All Patients coming to the Operative Dentistry Department (DIDC-DUHS) with complain of pain in posterior teeth will be invited to participate. The treatment will be done by one dentist. Patient's medical and dental history will be recorded, and tooth will be checked for swelling, sensitivity, cavity type, and loosening of tooth. Special tests like the cold test, electric pulp test, and an X-ray will help assess the tooth's condition. Patient will also be asked to rate pain from 1-10. Before starting the treatment, the procedure will be explained to patient in detail, and written consent will be taken. The treatment will be done in two visits by one dentist. Patient will be given an injection to make tooth pain-free so that patient does not feel any discomfort during the treatment and the area will be kept clean using a rubber sheet. The dentist will remove the hole in tooth and remove the infected soft part of tooth and stop the bleeding. Then one of the two materials will be placed inside the tooth. A temporary filling will be placed first, and patient will come the next day for the final filling. An X-ray will be taken to check the result. If patient feel pain, may take ibuprofen (400 mg) as needed, and if the pain continues, please contact the dentist. Patient will be called for follow-ups after 1 day, 1 week, 1 month, and 3 months to make sure the tooth is healing properly.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MTA | Experimental | Other: Biodentine pulpotomyPulpotomy material MTA |
| Biodentine | Experimental | Other: Biodentine pulpotomyPulpotomy material Biodentine |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Age between 18-40 years of both males and females
- Carious exposed maxillary and mandibular molars teeth
- Moderate to severe pain (VAS 4-10)
- Diagnosed with Symptomatic irreversible pulpitis on cold test and Electric pulp test (EPT)
- Periapical index of 1
Key exclusion criteria (6 listed)
- Any traumatic injury
- Non-restorable carious lesion
- Immature or Open apices of roots
- Internal or external Resorption
- Calcified canals
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 |
|---|---|---|
| Biodentine pulpotomyPulpotomy performed using Mineral Trioxide Aggregate (MTA) | Other | Biodentine, MTA |
Primary outcome
Short term outcome of complete pulpotomy using MTA vs Biodentine in Symptomatic Irreversible Pulpitis- A Randomized Controlled Trial
Time frame: 3 months
Clinical outcome measure through Electric pulp testing (EPT) and radiographic outcome measure through Periapical index (PAI)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Oct 2026.
- Individual participant dataSharing planned: No. IPD will not be shared outside the study team to ensure patient confidentiality and privacy. Data will be used only for the purposes of this study and will remain restricted to the research team
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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.
Dr Khadija Zubair, Postgraduate Trainee- FCPS principal investigator
Dow University of Health Sciences
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Biodentine pulpotomy in people with Symptomatic Irreversible Pulpitis (SIP), run by Dow University of Health Sciences at 2 sites in Pakistan.
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 7 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: looking for participants now, as of the sponsor's last update on 20 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Pakistan. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Dr Khadija Zubair, Postgraduate trainee- FCPS (03363605145, khadija.zubair21@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Short term outcome of complete pulpotomy using MTA vs Biodentine in Symptomatic Irreversible Pulpitis- A Randomized Controlled Trial (time frame: 3 months). 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 20 Oct 2026.