Symptomatic Irreversible PulpitisNCT07112859
Evaluation of Success of Complete Pulpotomy With Biodentine on Mature Permanent Single Rooted Teeth With Symptomatic Irreversible Pulpitis
A study testing Complete Pulpotomy with Biodentine in people with Symptomatic Irreversible Pulpitis, run by HITEC-Institute of Medical Sciences at 1 site in Pakistan.
Trial summary
This study aims to evaluate the clinical success of complete pulpotomy using Biodentine in mature permanent single-rooted teeth diagnosed with symptomatic irreversible pulpitis. Complete pulpotomy involves removal of the coronal pulp and preservation of radicular pulp vitality using a biocompatible pulp-capping… Read more about this study
- Who is it for?
- Ages 20 to 50 years
- Conditions the study is for
- Symptomatic Irreversible Pulpitis
- What is being tested?
- Complete Pulpotomy with Biodentine
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 sitePakistan
- Study dates
- 2 Jul 2024to 2 Jul 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 20 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Mature permanent single rooted teeth with:
- Symptomatic irreversible pulpitis
- Age group 20-50 years
Who cannot join
- • Uncontrolled pulp heamorrhage (more than 5mins)
- Necrotic pulp
- Periapical periodontitis
- Sinus tract
- Abnormal tooth mobility
- Single rooted teeth with internal or external root resorption
- Calcified root canals
Trial locations and contacts
1 site in 1 country.
About this study
This study aims to evaluate the clinical success of complete pulpotomy using Biodentine in mature permanent single-rooted teeth diagnosed with symptomatic irreversible pulpitis. Complete pulpotomy involves removal of the coronal pulp and preservation of radicular pulp vitality using a biocompatible pulp-capping material. Biodentine, a calcium silicate-based cement, has favorable biological properties, including biocompatibility, antibacterial effects, and dentin bridge formation potential. A total of 84 patients meeting the inclusion criteria will be enrolled and treated by a single operator. Clinical success will be evaluated at 7 days, 1 month, and 3 months based on absence of pain, swelling, tenderness to percussion, and radiographic signs of periapical pathology.
- Conditions
- Symptomatic Irreversible Pulpitis
- Being tested
- Complete Pulpotomy with Biodentine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Complete Pulpotomy with BiodentineProcedure or surgery
Administration of local anesthesia followed by rubber dam isolation.
Removal of coronal pulp tissue to perform a complete pulpotomy.
Hemostasis achieved with saline-soaked cotton pellet.
Placement of Biodentine as the pulp-capping agent on the radicular pulp.
Temporary restoration placed immediately after Biodentine placement.
Permanent composite restoration placed after 1 week.
Follow-up visits at 7 days, 1 month, and 3 months for clinical and radiographic evaluation.
| Study group | Role | What they receive |
|---|---|---|
| Complete Pulpotomy with Biodentine | Experimental | Patients with mature permanent single-rooted teeth diagnosed with symptomatic irreversible pulpitis will undergo complete pulpotomy. The coronal pulp will be removed, and Biodentine will be placed on the remaining radicular pulp, followed by restoration. Patients will be followed up to evaluate treatment success. Receives: Procedure: Complete Pulpotomy with Biodentine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Success of Complete Pulpotom
Clinical assessment of pain, swelling, and tenderness on percussion.
Radiographic evaluation for absence of periapical lesions and root resorption.
Success defined as absence of symptoms and radiographic signs of pathology, indicating maintenance of pulp vitality.
Measured: Evaluated at 7 days, 1 month, and 3 months post-procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2025
- Study start2 Jul 2024
- Primary completion2 Jul 2025
- Study completion2 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Symptomatic 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- HITEC-Institute of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr Farhana Altaf, HITEC-Institute of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07112859
- Sponsor's protocol ID
- Dr Farhana altaf
- Status last verified
- Aug 2025
- First submitted
- 1 Aug 2025
- Last updated
- 8 Aug 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ramani A, Sangwan P, Tewari S, Duhan J, Mittal S, Kumar V. Comparative evaluation of complete and partial pulpotomy in mature permanent teeth with symptomatic irreversible pulpitis: A randomized clinical trial. Int Endod J. 2022 May;55(5):430-440. doi: 10.1111/iej.13714. Epub 2022 Mar 10.
PubMed 35226769
Study at a glance
From the registry record, last updated by the sponsor on 8 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Success of Complete Pulpotomy With Biodentine on Mature Permanent Single Rooted Teeth With Symptomatic Irreversible Pulpitis
- ClinicalTrials.gov ID
- NCT07112859
- Acronym / sponsor ID
- Dr Farhana altaf
- Conditions
- Symptomatic Irreversible Pulpitis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- HITEC-Institute of Medical SciencesUniversity, hospital or other
- Study start
- 2 Jul 2024 (actual)
- Primary completion
- 2 Jul 2025 (actual)
- Study completion
- 2 Jul 2025 (actual)
- First posted
- 8 Aug 2025 (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 aims to evaluate the clinical success of complete pulpotomy using Biodentine in mature permanent single-rooted teeth diagnosed with symptomatic irreversible pulpitis. Complete pulpotomy involves removal of the coronal pulp and preservation of radicular pulp vitality using a biocompatible pulp-capping material. Biodentine, a calcium silicate-based cement, has favorable biological properties, including biocompatibility, antibacterial effects, and dentin bridge formation potential. A total of 84 patients meeting the inclusion criteria will be enrolled and treated by a single operator. Clinical success will be evaluated at 7 days, 1 month, and 3 months based on absence of pain, swelling, tenderness to percussion, and radiographic signs of periapical pathology.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Complete Pulpotomy with Biodentine | Experimental | Procedure: Complete Pulpotomy with BiodentinePatients with mature permanent single-rooted teeth diagnosed with symptomatic irreversible pulpitis will undergo complete pulpotomy. The coronal pulp will be removed, and Biodentine will be placed on the remaining radicular pulp, followed by restoration. Patients will be followed up to evaluate treatment success. |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Mature permanent single rooted teeth with:
Key exclusion criteria (7 listed)
- • Uncontrolled pulp heamorrhage (more than 5mins)
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 |
|---|---|---|
| Complete Pulpotomy with BiodentineAdministration of local anesthesia followed by rubber dam isolation. Removal of coronal pulp tissue to perform a complete pulpotomy. Hemostasis achieved with saline-soaked cotton pellet. Placement of Biodentine as the pulp-capping agent on the radicular pulp. Temporary restoration placed immediately after Biodentine placement. Permanent composite restoration placed after 1 week. Follow-up visits at 7 days, 1 month, and 3 months for clinical and radiographic evaluation. | Procedure or surgery | Complete Pulpotomy with Biodentine |
Primary outcome
Success of Complete Pulpotom
Time frame: Evaluated at 7 days, 1 month, and 3 months post-procedure
Clinical assessment of pain, swelling, and tenderness on percussion. Radiographic evaluation for absence of periapical lesions and root resorption. Success defined as absence of symptoms and radiographic signs of pathology, indicating maintenance of pulp vitality.
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 8 Aug 2025.
- Background: PubMed 35226769Ramani A, Sangwan P, Tewari S, Duhan J, Mittal S, Kumar V. Comparative evaluation of complete and partial pulpotomy in mature permanent teeth with symptomatic irreversible pulpitis: A randomized clinical trial. Int Endod J. 2022 May;55(5):430-440. doi: 10.1111/iej.13714. Epub 2022 Mar 10.
- 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 Complete Pulpotomy with Biodentine in people with Symptomatic Irreversible Pulpitis, run by HITEC-Institute of Medical Sciences at 1 site 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 3 inclusion and 7 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 8 Aug 2025. 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 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?
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?
Success of Complete Pulpotom (time frame: Evaluated at 7 days, 1 month, and 3 months post-procedure). 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 NCT07112859, which also lists 1 linked publication.
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 8 Aug 2025.