Pulpitis - IrreversibleNCT04397315
Comparative Evaluation of Partial and Complete Pulpotomy in Permanent Molars
A study testing Pulpotomy to the level of canal orifices and Pulpotomy up to superficial 2-3 mm of pulp chamber in people with Pulpitis - Irreversible, run by Postgraduate Institute of Dental Sciences Rohtak at 1 site in India.
Trial summary
This study will compare the outcome of partial pulpotomy and complete pulpotomy in mature permanent molars with clinical signs indicative of irreversible pulpitis Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Pulpitis - Irreversible
- What is being tested?
- Pulpotomy to the level of canal orifices and Pulpotomy up to superficial 2-3 mm of pulp chamber
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 74 participants
- Where
- 1 siteIndia
- Study dates
- 1 Jan 2019to 30 Jun 2020
- 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
- Healthy volunteers accepted
- Adult
Who may be able to join
- The patient should be ≥18 years of age.
- Restorable molar teeth.
- Tooth should give positive response to pulp sensibility testing.
- Clinical diagnosis of irreversible pulpitis.
- Tooth with probing pocket depth and mobility are within normal limits.
- No signs of pulpal necrosis including sinus tract or swelling.
- Non-contributory medical history
Who cannot join
- Teeth with immature roots.
- No pulp exposure after caries excavation.
- Bleeding could not be controlled in 6 minutes.
- Insufficient bleeding after pulp exposure, the pulp is judged necrotic or partially necrotic.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparative Evaluation of Partial and Complete Pulpotomy in Mature Permanent Molars With Clinical Signs Indicative of Irreversible Pulpitis
This study will compare the outcome of partial pulpotomy and complete pulpotomy in mature permanent molars with clinical signs indicative of irreversible pulpitis
Read the detailed description
After thorough history and clinical and radio graphic examination, and confirmation of eligibility for the study, written informed consent will be taken after explaining the procedure and its associated risks and benefits. Clinical diagnosis of irreversible pulpitis will be established based on a history of spontaneous pain or pain exacerbated by cold stimuli and lasting for a few seconds to several hours (lingering pain) compared to control teeth and which is reproducible using cold testing. Once included, study subjects will be randomly allocated to either Complete Pulpotomy group or Partial Pulpotomy group. (Mineral Trioxide Aggregate) MTA will be used as pulpotomy agent. A layer of resin modified Glass Ionomer liner will be placed over the MTA and tooth will be permanently restored with composite resin in second appointment.
Pain analysis will be carried out preoperatively and postoperatively at every 24 hours till 7 days after intervention. All the subjects will be followed up for evaluation of success at every 3 months from baseline to 1 year.
- Conditions
- Pulpitis - Irreversible
- Being tested
- Pulpotomy to the level of canal orifices, Pulpotomy up to superficial 2-3 mm of pulp chamber
- Keywords
- Irreversible Pulpitis, Complete Pulpotomy, Partial Pulpotomy, Vital Pulp Therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pulpotomy to the level of canal orificesProcedure or surgery
Pulp tissue will be removed till the level of canal orifices.
Pulpotomy up to superficial 2-3 mm of pulp chamberProcedure or surgery
Only superficial pulp from the chamber will be removed
| Study group | Role | What they receive |
|---|---|---|
| Complete Pulpotomy | Active comparator | In case of complete pulpotomy procedure the exposed pulp tissue will be amputated using sterile bur in high speed hand piece to the level of canal orifices. Receives: Procedure: Pulpotomy to the level of canal orifices |
| Partial Pulpotomy | Active comparator | In case of partial pulpotomy procedure the exposed pulp tissue will be amputated using a sterile bur in the high speed hand piece to a depth of 2-3 mm. Receives: Procedure: Pulpotomy up to superficial 2-3 mm of pulp chamber |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical Success and radiographic success
CLINICAL SUCCESS CRITERIA:
Absence of spontaneous pain, discomfort, swelling, sinus tract or tenderness to palpation or percussion.
RADIOGRAPHIC SUCCESS CRITERIA:
No pathosis evident on the radiograph such as root resorption, furcal pathosis or new periapical pathosis.
Periapical Index score 1 or 2 according to Orstavic et al.
Evaluation of both clinical and radiographic outcome is must for analyzing the actual success of therapeutic technique. Number of participants fulfilling both clinical as well as radiographic success criteria will be considered in success category.
Measured: Baseline to 12 Months
Secondary outcomes (1)
Pain analysis
To assess incidence and intensity of pain postoperatively at every 24 hours till 7 days using Visual analogue Scale of 0 to 10 Centimetere line. Score 0 means no pain and Score 10 means maximum pain.
Measured: Baseline to 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2020
- Study start1 Jan 2019
- Primary completion30 Jun 2020 (estimated)
- Study completion30 Jun 2020 (estimated)
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 Pulpitis - IrreversibleStudies of the same condition, open and under way.
- More trials run by Postgraduate Institute of Dental Sciences RohtakThe sponsor's other registered studies.
- 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
- 74 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Postgraduate Institute of Dental Sciences Rohtak
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- ANKITA RAMANI, Principal investigator, POST GRADUATE INSTITUTE OF DENTAL SCIENCES, ROHTAK
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04397315
- Sponsor's protocol ID
- Dr. Ankita Ramani
- Status last verified
- May 2020
- First submitted
- 12 May 2020
- Last updated
- 27 May 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ramani A, Sangwan P. Outcome Following Complete and Partial Pulpotomy in Managing Cariously Exposed Mature Permanent Molars With Symptomatic Irreversible Pulpitis: A 5-Year Follow-Up of a Randomised Clinical Trial. Int Endod J. 2025 Dec;58(12):1835-1848. doi: 10.1111/iej.70028. Epub 2025 Sep 2.
PubMed 40898413Ramani 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 27 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Evaluation of Partial and Complete Pulpotomy in Mature Permanent Molars With Clinical Signs Indicative of Irreversible Pulpitis
- ClinicalTrials.gov ID
- NCT04397315
- Acronym / sponsor ID
- Dr. Ankita Ramani
- Conditions
- Pulpitis - Irreversible
- Keywords
- Irreversible Pulpitis, Complete Pulpotomy, Partial Pulpotomy, Vital Pulp Therapy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 74 participants (estimated)
- Lead sponsor
- Postgraduate Institute of Dental Sciences RohtakUniversity, hospital or other
- Study start
- 1 Jan 2019 (actual)
- Primary completion
- 30 Jun 2020 (estimated)
- Study completion
- 30 Jun 2020 (estimated)
- First posted
- 21 May 2020 (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 will compare the outcome of partial pulpotomy and complete pulpotomy in mature permanent molars with clinical signs indicative of irreversible pulpitis
Detailed description
After thorough history and clinical and radio graphic examination, and confirmation of eligibility for the study, written informed consent will be taken after explaining the procedure and its associated risks and benefits. Clinical diagnosis of irreversible pulpitis will be established based on a history of spontaneous pain or pain exacerbated by cold stimuli and lasting for a few seconds to several hours (lingering pain) compared to control teeth and which is reproducible using cold testing. Once included, study subjects will be randomly allocated to either Complete Pulpotomy group or Partial Pulpotomy group. (Mineral Trioxide Aggregate) MTA will be used as pulpotomy agent. A layer of resin modified Glass Ionomer liner will be placed over the MTA and tooth will be permanently restored with composite resin in second appointment.
Pain analysis will be carried out preoperatively and postoperatively at every 24 hours till 7 days after intervention. All the subjects will be followed up for evaluation of success at every 3 months from baseline to 1 year.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Complete Pulpotomy | Active comparator | Procedure: Pulpotomy to the level of canal orificesIn case of complete pulpotomy procedure the exposed pulp tissue will be amputated using sterile bur in high speed hand piece to the level of canal orifices. |
| Partial Pulpotomy | Active comparator | Procedure: Pulpotomy up to superficial 2-3 mm of pulp chamberIn case of partial pulpotomy procedure the exposed pulp tissue will be amputated using a sterile bur in the high speed hand piece to a depth of 2-3 mm. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- The patient should be ≥18 years of age.
- Restorable molar teeth.
- Tooth should give positive response to pulp sensibility testing.
- Clinical diagnosis of irreversible pulpitis.
- Tooth with probing pocket depth and mobility are within normal limits.
Key exclusion criteria (4 listed)
- Teeth with immature roots.
- No pulp exposure after caries excavation.
- Bleeding could not be controlled in 6 minutes.
- Insufficient bleeding after pulp exposure, the pulp is judged necrotic or partially necrotic.
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 |
|---|---|---|
| Pulpotomy to the level of canal orificesPulp tissue will be removed till the level of canal orifices. | Procedure or surgery | Complete Pulpotomy |
| Pulpotomy up to superficial 2-3 mm of pulp chamberOnly superficial pulp from the chamber will be removed | Procedure or surgery | Partial Pulpotomy |
Primary outcome
Clinical Success and radiographic success
Time frame: Baseline to 12 Months
CLINICAL SUCCESS CRITERIA: Absence of spontaneous pain, discomfort, swelling, sinus tract or tenderness to palpation or percussion. RADIOGRAPHIC SUCCESS CRITERIA: No pathosis evident on the radiograph such as root resorption, furcal pathosis or new periapical pathosis. Periapical Index score 1 or 2 according to Orstavic et al. Evaluation of both clinical and radiographic outcome is must for analyzing the actual success of therapeutic technique. Number of participants fulfilling both clinical as well as radiographic success criteria will be considered in success category.
1 secondary outcome
Pain analysis
Time frame: Baseline to 7 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 May 2020.
- Derived from this study: PubMed 40898413Ramani A, Sangwan P. Outcome Following Complete and Partial Pulpotomy in Managing Cariously Exposed Mature Permanent Molars With Symptomatic Irreversible Pulpitis: A 5-Year Follow-Up of a Randomised Clinical Trial. Int Endod J. 2025 Dec;58(12):1835-1848. doi: 10.1111/iej.70028. Epub 2025 Sep 2.
- Derived from this study: 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.
ANKITA RAMANI principal investigator
POST GRADUATE INSTITUTE OF DENTAL SCIENCES, ROHTAK
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 to the level of canal orifices and Pulpotomy up to superficial 2-3 mm of pulp chamber in people with Pulpitis - Irreversible, run by Postgraduate Institute of Dental Sciences Rohtak at 1 site in India.
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 4 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 27 May 2020. 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 India. 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?
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?
Clinical Success and radiographic success (time frame: Baseline to 12 Months). 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 NCT04397315, 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 27 May 2020.