Pulpitis - IrreversibleNCT05406557
Partial Versus Miniature Pulpotomy in Teeth With Irreversible Pulpitis
A study testing Partial pulpotomy and Miniature pulpotomy 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 and miniature pulpotomy in mature permanent molars with symptomatic partial irreversible pulpitis Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Pulpitis - Irreversible
- What is being tested?
- Partial pulpotomy and Miniature pulpotomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 86 participants
- Where
- 1 siteIndia
- Study dates
- 12 May 2022to Jul 2023
- 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 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- The patient with18 -45 years of age.
- Restorable molar teeth.
- Tooth should give positive response to pulp sensibility testing.
- Clinical diagnosis of symptomatic partial 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.
India1 site, 1 recruiting
- Recruiting
Dr. Ankita Ramani
Rohtak, Haryana, 124001
DR. ANKITA RAMANI, MDS, 09582841539, ramaniankita95@gmail.com
About this study
Official title: Outcome Comparing Partial and Miniature Pulpotomy in Mature Permanent Molars With Symptomatic Partial Irreversible Pulpitis
This study will compare the outcome of partial and miniature pulpotomy in mature permanent molars with symptomatic partial irreversible pulpitis
Read the detailed description
After thorough history and clinical and radiographic examination, and confirmation of eligibility for the study, written informed consent will be obtained from study participants after explaining the procedure and its associated risks and benefits. Clinical diagnosis of symptomatic partial 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 Miniature Pulpotomy group or Partial Pulpotomy group. MTA (Mineral Trioxide Aggregate) 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 same 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 clinical and radiographic success at 6 and 12 months from baseline.
- Conditions
- Pulpitis - Irreversible
- Being tested
- Partial pulpotomy, Miniature pulpotomy
- Keywords
- Irreversible pulpitis, Partial pulpotomy, Miniature pulpotomy, Vital pulp therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Partial pulpotomyProcedure or surgery
In case of partial pulpotomy procedure the exposed pulp tissue will be amputated using a sterile bur in the high speed hand piece with water coolant to a depth of superficial 2-3 mm of pulp chamber.
Miniature pulpotomyProcedure or surgery
In case of miniature pulpotomy procedure the exposed pulp tissue will be amputated using a sterile bur in the high speed hand piece with water coolant to a depth of superficial 2-3 mm of only affected pulp horn
| Study group | Role | What they receive |
|---|---|---|
| Partial pulpotomy | Active comparator | Removal of superficial 2-3 mm of pulp tissue from entire pulp chamber Receives: Procedure: Partial pulpotomy |
| Miniature pulpotomy | Active comparator | Removal of superficial 2-3 mm of pulp tissue from only affected pulp horn Receives: Procedure: Miniature pulpotomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical and radiographic success
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 (2)
Pain analysis
To assess incidence and intensity of pain postoperatively at every 24 hours till 7 days using Visual analogue Scale of 0 to 100 millimeter line. Score 0 means no pain and Score 100 means maximum pain
Measured: Baseline to 7 days
Pulp sensibility testing
To assess pulp tissue response using cold and electric pulp test at 6 and 12 months
Measured: Baseline to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2022
- Study start12 May 2022
- Primary completionJul 2023 (estimated)
- Study completionJul 2023 (estimated)
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 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 86 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Postgraduate Institute of Dental Sciences Rohtak
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- DR. ANKITA RAMANI, MDS, Principal investigator, PGIDS, ROHTAK, HARYANA, INDIA-124001
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05406557
- Sponsor's protocol ID
- DR. A RAMANI
- Status last verified
- May 2022
- First submitted
- 29 May 2022
- Last updated
- 6 Jun 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ramani A, Sangwan P, Duhan J, Popat S, Sangwan A. Effect of lateral extent of pulp tissue removal on the outcome of partial pulpotomy for managing cariously exposed mature permanent molars with symptomatic irreversible pulpitis: A randomized clinical trial. Int Endod J. 2025 Jan;58(1):71-83. doi: 10.1111/iej.14152. Epub 2024 Oct 1.
PubMed 39352296
Study at a glance
From the registry record, last updated by the sponsor on 6 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Outcome Comparing Partial and Miniature Pulpotomy in Mature Permanent Molars With Symptomatic Partial Irreversible Pulpitis
- ClinicalTrials.gov ID
- NCT05406557
- Acronym / sponsor ID
- DR. A RAMANI
- Conditions
- Pulpitis - Irreversible
- Keywords
- Irreversible pulpitis, Partial pulpotomy, Miniature pulpotomy, Vital pulp therapy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 86 participants (estimated)
- Lead sponsor
- Postgraduate Institute of Dental Sciences RohtakUniversity, hospital or other
- Study start
- 12 May 2022 (actual)
- Primary completion
- Jul 2023 (estimated)
- Study completion
- Jul 2023 (estimated)
- First posted
- 6 Jun 2022 (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 and miniature pulpotomy in mature permanent molars with symptomatic partial irreversible pulpitis
Detailed description
After thorough history and clinical and radiographic examination, and confirmation of eligibility for the study, written informed consent will be obtained from study participants after explaining the procedure and its associated risks and benefits. Clinical diagnosis of symptomatic partial 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 Miniature Pulpotomy group or Partial Pulpotomy group. MTA (Mineral Trioxide Aggregate) 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 same 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 clinical and radiographic success at 6 and 12 months from baseline.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Partial pulpotomy | Active comparator | Procedure: Partial pulpotomyRemoval of superficial 2-3 mm of pulp tissue from entire pulp chamber |
| Miniature pulpotomy | Active comparator | Procedure: Miniature pulpotomyRemoval of superficial 2-3 mm of pulp tissue from only affected pulp horn |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- The patient with18 -45 years of age.
- Restorable molar teeth.
- Tooth should give positive response to pulp sensibility testing.
- Clinical diagnosis of symptomatic partial 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 |
|---|---|---|
| Partial pulpotomyIn case of partial pulpotomy procedure the exposed pulp tissue will be amputated using a sterile bur in the high speed hand piece with water coolant to a depth of superficial 2-3 mm of pulp chamber. | Procedure or surgery | Partial pulpotomy |
| Miniature pulpotomyIn case of miniature pulpotomy procedure the exposed pulp tissue will be amputated using a sterile bur in the high speed hand piece with water coolant to a depth of superficial 2-3 mm of only affected pulp horn | Procedure or surgery | Miniature pulpotomy |
Primary outcome
Clinical and radiographic success
Time frame: Baseline to 12 Months
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.
2 secondary outcomes
Pain analysis
Time frame: Baseline to 7 days
Pulp sensibility testing
Time frame: Baseline to 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jun 2022.
- Derived from this study: PubMed 39352296Ramani A, Sangwan P, Duhan J, Popat S, Sangwan A. Effect of lateral extent of pulp tissue removal on the outcome of partial pulpotomy for managing cariously exposed mature permanent molars with symptomatic irreversible pulpitis: A randomized clinical trial. Int Endod J. 2025 Jan;58(1):71-83. doi: 10.1111/iej.14152. Epub 2024 Oct 1.
- 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.
DR. ANKITA RAMANI, MDS principal investigator
PGIDS, ROHTAK, HARYANA, INDIA-124001
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Partial pulpotomy and Miniature pulpotomy 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 6 Jun 2022. 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?
Contact DR. ANKITA RAMANI, MDS (+919582841539, ramaniankita95@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical 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 NCT05406557, 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 6 Jun 2022.