Moderate PulpitisNCT07123025
Outcome of Partial Pulpotomy in Moderate and Severe Pulpitis
A study testing Partial Pulpotomy in Moderate Pulpitis and Partial Pulpotomy in Severe Pulpitis in people with Moderate Pulpitis and Severe Pulpitis, run by Postgraduate Institute of Dental Sciences Rohtak at 1 site in India.
Trial summary
The aim of the study is to compare the outcome of Partial Pulpotomy in mature permanent teeth with moderate and severe pulpitis. OBJECTIVE: Primary objective- to compare the difference in clinical and radiographic outcome of partial pulpotomy in mature permanent teeth with moderate and severe Pulpitis. Read more about this study
- Who is it for?
- Ages 15 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Moderate Pulpitis, Severe Pulpitis, Extremely Deep Caries
- What is being tested?
- Partial Pulpotomy in Moderate Pulpitis and Partial Pulpotomy in Severe Pulpitis
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteIndia
- Study dates
- 18 Apr 2025to 18 Apr 2027
- 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 15 to 40 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Patients aged 15-40 years.
- Mature permanent mandibular molars with extremely deep caries on radiograph, giving positive response to pulp sensibility test.
- For Moderate Pulpitis- strong, heightened and prolonged reaction to cold, which can last for minutes, possibly percussion sensitive and spontaneous dull pain that can be more or less suppressed with pain medication.
- For Severe Pulpitis- Severe spontaneous pain and clear pain reaction to warmth and cold stimuli, often, sharp to dull throbbing pain, patients have trouble sleeping because of the pain (gets worse when lying down). Tooth is very sensitive to touch and percussion.
- Pulpal bleeding can be controlled within 10 minutes
- Patients having normal periapical status with periapical index (PAI) score ≤ 2
- Periodontally healthy teeth
- Positive response to pulp sensibility test
Who cannot join
- Non restorable teeth
- Negative response to vitality testing
- Presence of sinus tract or soft tissue swelling
- Absence of deep carious lesions radiographically
- Radiographic signs of internal or external root resorption
- Patient had moderate to severe pain, but preferred root canal treatment
Show all 11Show fewer
- Presence of sound dentin over pulp and pulp not exposed intraoperatively
- Pulp haemorrhage could not be arrested within 10 minutes.
- Necrotic pulp evident upon exposure
- Pregnant women
- Absence of antagonist teeth
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
India1 site, 1 recruiting
- Recruiting
PGIDS Rohtak
Rohtak, Haryana, 124001
Dr. Pankaj Sangwan, MDS, 9996112202, drps_1@yahoo.co.in
Dr. Prerna Yadav, PG student, 9763276071, viks0267@gmail.com
About this study
The aim of the study is to compare the outcome of Partial Pulpotomy in mature permanent teeth with moderate and severe pulpitis.
OBJECTIVE: Primary objective- to compare the difference in clinical and radiographic outcome of partial pulpotomy in mature permanent teeth with moderate and severe Pulpitis. Secondary objective- To evaluate and compare OHRQoL and postoperative pain after Partial Pulpotomy in teeth with Moderate Pulpitis and Severe Pulpitis. Subjects of age group 15 to 40 years will be included and divided into two groups
- Permanent mature molars with Moderate Pulpitis
- Permanent mature molars with Severe Pulpitis
Read the detailed description
TITLE- Outcome of Partial Pulpotomy in Moderate and Severe Pulpitis It aims to answer does outcome of partial pulpotomy differ in mature permanent teeth with moderate and severe pulpitis? P (Population) - Mature permanent mandibular molars with clinical signs of irreversible pulpitis. I (Intervention) -Partial Pulpotomy in teeth with Moderate Pulpitis. C (Comparison) -Partial Pulpotomy in teeth with Severe Pulpitis. O (Outcome) -Assessment of clinical \& radiographic success at 6 and 12 months follow up
-Assessment of OHRQoL \& pain experience at baseline, post-operatively every 24 hours for 1 week Various studies showed partial pulpotomy is successful in managing cases of irreversible pulpitis. The word irreversible presents a problem as at least part of the pulp can be saved. As a result, Wolter's proposed a classification system based on severity of symptoms. However, the treatment modalities proposed under the classification system need to validated by further research. To the best of our knowledge, Careddu \& Duncan remains the only study that has explored the success of partial pulpotomy in terms of Wolter's classification but had low numbers and uneven distribution of moderate and severe pulpitis cases. No other clinical trials were found that compared the outcomes of partial pulpotomy in cases of moderate and severe pulpitis, where ambiguity still exists regarding the best treatment modality. This study trial aims to compare the difference in clinical and radiographic outcome of partial pulpotomy in mature permanent teeth with moderate and severe pulpitis.
- Conditions
- Moderate Pulpitis, Severe Pulpitis, Extremely Deep Caries
- Being tested
- Partial Pulpotomy in Moderate Pulpitis, Partial Pulpotomy in Severe Pulpitis
- Keywords
- partial pulpotomy
- Medical subject headings
- Pulpitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Partial Pulpotomy in Moderate PulpitisProcedure or surgery
Procedure/Surgery: Outcome of partial pulpotomy in teeth with clinical signs indicative of Moderate Pulpitis.
After caries removal and pulp exposure pulp tissue is amputated and pulpal wound will be irrigated with 3% NaOCl, and bleeding will be controlled by placing a cotton pellet soaked with 3% NaOCl over the pulpal wound for 2 to 3 minutes and will be repeated if required. Root canal therapy will be initiated in cases in which haemostasis is not achieved even after 10 minutes. Followed by capping with 2-3mm layer of MTA. A layer of RMGIC will be placed over the MTA. Then the tooth will be permanently restored with composite resin.
Partial Pulpotomy in Severe PulpitisProcedure or surgery
Description: Procedure/Surgery: Outcome of partial pulpotomy in teeth with clinical signs indicative of Severe Pulpitis. After caries removal and pulp exposure pulp tissue is amputated and pulpal wound will be irrigated with 3% NaOCl, and bleeding will be controlled by placing a cotton pellet soaked with 3% NaOCl over the pulpal wound for 2 to 3 minutes and will be repeated if required. Root canal therapy will be initiated in cases in which haemostasis is not achieved even after 10 minutes. Followed by capping with 2-3mm layer of MTA. A layer of RMGIC will be placed over the MTA. Then the tooth will be permanently restored with composite resin
| Study group | Role | What they receive |
|---|---|---|
| Partial Pulpotomy in Moderate Pulpitis | Experimental | Partial Pulpotomy will be performed after establishing a clinical diagnosis of moderate pulpitis i.e. if the tooth showed symptoms triggered by cold stimuli or percussion that lasted for minutes, but pain could be stopped using medications. Receives: Procedure: Partial Pulpotomy in Moderate Pulpitis |
| Partial Pulpotomy in Severe Pulpitis | Active comparator | Partial Pulpotomy will be performed after establishing a clinical diagnosis of Severe pulpitis i.e. if the tooth showed symptoms of severe spontaneous pain and clear pain reaction to warmth and cold stimuli, often, sharp to dull throbbing pain, patients have trouble sleeping because of the pain (gets worse when lying down) and tooth sensitive to touch and percussion Receives: Procedure: Partial Pulpotomy in Severe Pulpitis |
What is being measured
The primary outcome is the main question the study is designed to answer.
success rate at one year
Criteria for success:-
Clinical:
- Absence of signs and symptoms of spontaneous pain or pain on stimulus and discomfort except for the first few days after treatment.
- No tenderness to palpation or percussion and the tooth is functional.
- Normal mobility and probing pocket depth.
- Absence of associated soft tissue swelling, sinus or fistula. Radiographic: -
- Absence of any periapical or interradicular radiolucency. 2. Complete radiographic healing (PAI score 1 or 2 acc. to Ostravik et al). 3. Absence of internal and external root resorption Tooth will be considered successful when all the above parameters are met.
Measured: Baseline to 12 months
Secondary outcomes (2)
Postoperative Pain
Post Operative Pain 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 Score100 means maximum pain. 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 and at 24 hours, Day 2, Day 3, Day 4, Day 5, Day 6 and Day 7 after the treatment
OHRQoL assessment
OHIP-14 questionnare will be used to assess the quality of life.It consists of questionnaire in seven dimensions: functional limitation, physical pain, psychological discomfort, physical disability, psychological disability, social disability, and handicap. It will be scored using a Lickert scale: never=0; hardly ever=1; occasionally=2; fairly often=3; very often=4. Total score will be calculated ranging from 0-56, with higher score denoting the worst OHRQoL
Measured: Baseline and at 24 hours, Day 2, Day 3, Day 4, Day 5, Day 6 and Day 7 after the treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2025
- Study start18 Apr 2025
- Primary completion18 Apr 2026 (estimated)
- Study completion18 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Moderate PulpitisStudies 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Postgraduate Institute of Dental Sciences Rohtak
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Dr. Pankaj Sangwan, MDS, Principal investigator, PGIDS, Rohtak, Haryana 124001
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07123025
- Sponsor's protocol ID
- Prerna Yadav
- Status last verified
- Aug 2025
- First submitted
- 23 Jun 2025
- Last updated
- 28 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Outcome of Partial Pulpotomy in Moderate and Severe Pulpitis
- ClinicalTrials.gov ID
- NCT07123025
- Acronym / sponsor ID
- Prerna Yadav
- Conditions
- Moderate Pulpitis, Severe Pulpitis, Extremely Deep Caries
- Keywords
- partial pulpotomy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Postgraduate Institute of Dental Sciences RohtakUniversity, hospital or other
- Study start
- 18 Apr 2025 (actual)
- Primary completion
- 18 Apr 2026 (estimated)
- Study completion
- 18 Apr 2027 (estimated)
- First posted
- 14 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.
The aim of the study is to compare the outcome of Partial Pulpotomy in mature permanent teeth with moderate and severe pulpitis.
OBJECTIVE: Primary objective- to compare the difference in clinical and radiographic outcome of partial pulpotomy in mature permanent teeth with moderate and severe Pulpitis. Secondary objective- To evaluate and compare OHRQoL and postoperative pain after Partial Pulpotomy in teeth with Moderate Pulpitis and Severe Pulpitis. Subjects of age group 15 to 40 years will be included and divided into two groups
- Permanent mature molars with Moderate Pulpitis
- Permanent mature molars with Severe Pulpitis
Detailed description
TITLE- Outcome of Partial Pulpotomy in Moderate and Severe Pulpitis It aims to answer does outcome of partial pulpotomy differ in mature permanent teeth with moderate and severe pulpitis? P (Population) - Mature permanent mandibular molars with clinical signs of irreversible pulpitis. I (Intervention) -Partial Pulpotomy in teeth with Moderate Pulpitis. C (Comparison) -Partial Pulpotomy in teeth with Severe Pulpitis. O (Outcome) -Assessment of clinical \& radiographic success at 6 and 12 months follow up
-Assessment of OHRQoL \& pain experience at baseline, post-operatively every 24 hours for 1 week Various studies showed partial pulpotomy is successful in managing cases of irreversible pulpitis. The word irreversible presents a problem as at least part of the pulp can be saved. As a result, Wolter's proposed a classification system based on severity of symptoms. However, the treatment modalities proposed under the classification system need to validated by further research. To the best of our knowledge, Careddu \& Duncan remains the only study that has explored the success of partial pulpotomy in terms of Wolter's classification but had low numbers and uneven distribution of moderate and severe pulpitis cases. No other clinical trials were found that compared the outcomes of partial pulpotomy in cases of moderate and severe pulpitis, where ambiguity still exists regarding the best treatment modality. This study trial aims to compare the difference in clinical and radiographic outcome of partial pulpotomy in mature permanent teeth with moderate and severe pulpitis.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Partial Pulpotomy in Moderate Pulpitis | Experimental | Procedure: Partial Pulpotomy in Moderate PulpitisPartial Pulpotomy will be performed after establishing a clinical diagnosis of moderate pulpitis i.e. if the tooth showed symptoms triggered by cold stimuli or percussion that lasted for minutes, but pain could be stopped using medications. |
| Partial Pulpotomy in Severe Pulpitis | Active comparator | Procedure: Partial Pulpotomy in Severe PulpitisPartial Pulpotomy will be performed after establishing a clinical diagnosis of Severe pulpitis i.e. if the tooth showed symptoms of severe spontaneous pain and clear pain reaction to warmth and cold stimuli, often, sharp to dull throbbing pain, patients have trouble sleeping because of the pain (gets worse when lying down) and tooth sensitive to touch and percussion |
Who may qualify
- Ages
- 15 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (8 listed)
- Patients aged 15-40 years.
- Mature permanent mandibular molars with extremely deep caries on radiograph, giving positive response to pulp sensibility test.
- For Moderate Pulpitis- strong, heightened and prolonged reaction to cold, which can last for minutes, possibly percussion sensitive and spontaneous dull pain that can be more or less suppressed with pain medication.
- For Severe Pulpitis- Severe spontaneous pain and clear pain reaction to warmth and cold stimuli, often, sharp to dull throbbing pain, patients have trouble sleeping because of the pain (gets worse when lying down). Tooth is very sensitive to touch and percussion.
- Pulpal bleeding can be controlled within 10 minutes
Key exclusion criteria (11 listed)
- Non restorable teeth
- Negative response to vitality testing
- Presence of sinus tract or soft tissue swelling
- Absence of deep carious lesions radiographically
- Radiographic signs of internal or external root resorption
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 Pulpotomy in Moderate PulpitisProcedure/Surgery: Outcome of partial pulpotomy in teeth with clinical signs indicative of Moderate Pulpitis. After caries removal and pulp exposure pulp tissue is amputated and pulpal wound will be irrigated with 3% NaOCl, and bleeding will be controlled by placing a cotton pellet soaked with 3% NaOCl over the pulpal wound for 2 to 3 minutes and will be repeated if required. Root canal therapy will be initiated in cases in which haemostasis is not achieved even after 10 minutes. Followed by capping with 2-3mm layer of MTA. A layer of RMGIC will be placed over the MTA. Then the tooth will be permanently restored with composite resin. | Procedure or surgery | Partial Pulpotomy in Moderate Pulpitis |
| Partial Pulpotomy in Severe PulpitisDescription: Procedure/Surgery: Outcome of partial pulpotomy in teeth with clinical signs indicative of Severe Pulpitis. After caries removal and pulp exposure pulp tissue is amputated and pulpal wound will be irrigated with 3% NaOCl, and bleeding will be controlled by placing a cotton pellet soaked with 3% NaOCl over the pulpal wound for 2 to 3 minutes and will be repeated if required. Root canal therapy will be initiated in cases in which haemostasis is not achieved even after 10 minutes. Followed by capping with 2-3mm layer of MTA. A layer of RMGIC will be placed over the MTA. Then the tooth will be permanently restored with composite resin | Procedure or surgery | Partial Pulpotomy in Severe Pulpitis |
Primary outcome
success rate at one year
Time frame: Baseline to 12 months
Criteria for success:- Clinical: 1. Absence of signs and symptoms of spontaneous pain or pain on stimulus and discomfort except for the first few days after treatment. 2. No tenderness to palpation or percussion and the tooth is functional. 3. Normal mobility and probing pocket depth. 4. Absence of associated soft tissue swelling, sinus or fistula. Radiographic: - 1. Absence of any periapical or interradicular radiolucency. 2. Complete radiographic healing (PAI score 1 or 2 acc. to Ostravik et al). 3. Absence of internal and external root resorption Tooth will be considered successful when all the above parameters are met.
2 secondary outcomes
Postoperative Pain
Time frame: Baseline and at 24 hours, Day 2, Day 3, Day 4, Day 5, Day 6 and Day 7 after the treatment
OHRQoL assessment
Time frame: Baseline and at 24 hours, Day 2, Day 3, Day 4, Day 5, Day 6 and Day 7 after the treatment
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 28 Aug 2025.
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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. Pankaj Sangwan, MDS principal investigator
PGIDS, Rohtak, Haryana 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 in Moderate Pulpitis and Partial Pulpotomy in Severe Pulpitis in people with Moderate Pulpitis and Severe Pulpitis, 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 8 inclusion and 11 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 28 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 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?
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. Pankaj Sangwan, MDS (9996112202, drps_1@yahoo.co.in), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
success rate at one year (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?
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 28 Aug 2025.