Reversible PulpitisNCT07300124
Outcome of Direct Pulp Capping and Partial Pulpotomy in Reversible Pulpitis
A study testing Partial Pulpotomy in Reversible Pulpitis and Direct pulp capping with MTA in people with Reversible Pulpitis and Extremely Deep Caries, run by Postgraduate Institute of Dental Sciences Rohtak at 1 site in India.
Trial summary
AIM: -The aim of the study is to compare the outcome of Direct Pulp Capping and Partial Pulpotomy in mature permanent teeth with Reversible Pulpitis OBJECTIVES: - Primary Objective: to compare the difference in clinical and radiographic outcome of direct pulp capping and partial pulpotomy in mature permanent teeth… Read more about this study
- Who is it for?
- Ages 15 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Reversible Pulpitis, Extremely Deep Caries
- What is being tested?
- Partial Pulpotomy in Reversible Pulpitis and Direct pulp capping with MTA
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 138 participants
- Where
- 1 siteIndia
- Study dates
- 10 Dec 2025to 10 Dec 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.
- 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 12Show 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
- Intake of antibiotics in last 30 days
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
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
AIM: -The aim of the study is to compare the outcome of Direct Pulp Capping and Partial Pulpotomy in mature permanent teeth with Reversible Pulpitis OBJECTIVES: - Primary Objective: to compare the difference in clinical and radiographic outcome of direct pulp capping and partial pulpotomy in mature permanent teeth with Reversible Pulpitis. Secondary objective: To evaluate and compare postoperative pain after Direct Pulp Capping and Partial Pulpotomy in teeth with Reversible Pulpitis STUDY GROUPS: - Subjects of age group 15 to 40 years will be included and divided into two groups
- Direct Pulp Capping in Permanent mature molars with Reversible Pulpitis
- Partial Pulpotomy in Permanent mature molars with Reversible Pulpitis
Read the detailed description
TITLE: Outcome of Direct Pulp Capping and Partial Pulpotomy in Reversible Pulpitis It aims to answer does outcome of direct pulp capping and partial pulpotomy differ in mature permanent teeth with extremely deep caries with reversible pulpitis. P (Population) - Mature permanent mandibular molars with extremely deep caries and clinical signs of reversible pulpitis. I (Intervention) -Direct Pulp Capping in teeth with Reversible Pulpitis. C (Comparison) -Partial Pulpotomy in teeth with Reversible Pulpitis. O (Outcome) -Assessment of clinical \& radiographic success at 6 and 12 months follow up -Assessment of pain experience at baseline, post-operatively every 24 hours for 1 week In extremely deep lesions, the dental pulp is often inflamed or at risk of microbial contamination, therefore requiring timely and precise intervention in order to preserve pulp vitality. In such cases, the removal of the superficial 2-3 mm of inflamed pulp tissue can help maintain the health of the remaining pulpal tissue. Duncan and other researchers have emphasized the importance of assessing both caries depth and pulpal status for deciding the effective treatment plan. Although numerous studies have investigated the outcomes of Direct Pulp Capping (DPC) and Partial Pulpotomy separately \& have included cases based on caries depth \& pulpal status, such as reversible pulpitis. However, there remains a notable lack of comparative clinical studies directly evaluating partial pulpotomy and direct pulp capping under standardized conditions involving extremely deep carious lesions with pulpal status as reversible pulpitis. Hence, this clinical trial aims to assess and compare the clinical and radiographic outcome of Direct Pulp Capping and Partial Pulpotomy in extremely deep caries with reversible pulpitis.
- Conditions
- Reversible Pulpitis, Extremely Deep Caries
- Being tested
- Partial Pulpotomy in Reversible Pulpitis, Direct pulp capping with MTA
- Keywords
- Partial Pulpotomy, Direct pulp capping
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Partial Pulpotomy in Reversible PulpitisProcedure or surgery
Procedure/Surgery: Outcome of Partial Pulpotomy in teeth with clinical signs indicative of Reversible Pulpitis with extremely deep caries.
After caries removal and pulp exposure , 2-3 mm of pulp tissue will be amputated and the pulpal wound irrigated with 3% NaOCl. Bleeding will be controlled by placing a cotton pellet soaked in 3% NaOCl over the pulpal wound for 2-3 minutes, repeated if required. This will be followed by capping with a 2-3 mm layer of MTA in both the groups. A layer of RMGIC will then be placed over the MTA, and the tooth will be permanently restored with composite resin.
Direct pulp capping with MTAProcedure or surgery
Outcome of direct pulp capping in teeth with clinical signs indicative of reversible pulpitis.
After caries removal and pulp exposure 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. Followed by capping with 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 |
|---|---|---|
| Direct Pulp Capping in Reversible Pulpitis | Experimental | Direct Pulp Capping will be performed on carious pulp exposure after establishing a clinical diagnosis of symptomatic reversible pulpitis based on history of pain exacerbated by cold stimuli and subsides on removal of stimuli compared to normal teeth and which is reproducible using cold testing. Receives: Procedure: Direct pulp capping with MTA |
| Partial Pulpotomy in Reversible Pulpitis | Active comparator | Partial Pulpotomy will be performed on carious pulp exposure after establishing a clinical diagnosis of symptomatic reversible pulpitis based on history of pain exacerbated by cold stimuli and subsides on removal of stimuli compared to normal teeth and which is reproducible using cold testing. Receives: Procedure: Partial Pulpotomy in Reversible Pulpitis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Success rate at 1 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 (1)
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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2025
- Study start10 Dec 2025 (estimated)
- Primary completion15 Jun 2027 (estimated)
- Study completion10 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Reversible 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 138 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
- NCT07300124
- Sponsor's protocol ID
- Pankaj Sangwan
- Status last verified
- Dec 2025
- First submitted
- 10 Dec 2025
- Last updated
- 23 Dec 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 23 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Outcome of Direct Pulp Capping and Partial Pulpotomy in Reversible Pulpitis
- ClinicalTrials.gov ID
- NCT07300124
- Acronym / sponsor ID
- Pankaj Sangwan
- Conditions
- Reversible Pulpitis, Extremely Deep Caries
- Keywords
- Partial Pulpotomy, Direct pulp capping
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 138 participants (estimated)
- Lead sponsor
- Postgraduate Institute of Dental Sciences RohtakUniversity, hospital or other
- Study start
- 10 Dec 2025 (estimated)
- Primary completion
- 15 Jun 2027 (estimated)
- Study completion
- 10 Dec 2027 (estimated)
- First posted
- 23 Dec 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.
AIM: -The aim of the study is to compare the outcome of Direct Pulp Capping and Partial Pulpotomy in mature permanent teeth with Reversible Pulpitis OBJECTIVES: - Primary Objective: to compare the difference in clinical and radiographic outcome of direct pulp capping and partial pulpotomy in mature permanent teeth with Reversible Pulpitis. Secondary objective: To evaluate and compare postoperative pain after Direct Pulp Capping and Partial Pulpotomy in teeth with Reversible Pulpitis STUDY GROUPS: - Subjects of age group 15 to 40 years will be included and divided into two groups
- Direct Pulp Capping in Permanent mature molars with Reversible Pulpitis
- Partial Pulpotomy in Permanent mature molars with Reversible Pulpitis
Detailed description
TITLE: Outcome of Direct Pulp Capping and Partial Pulpotomy in Reversible Pulpitis It aims to answer does outcome of direct pulp capping and partial pulpotomy differ in mature permanent teeth with extremely deep caries with reversible pulpitis. P (Population) - Mature permanent mandibular molars with extremely deep caries and clinical signs of reversible pulpitis. I (Intervention) -Direct Pulp Capping in teeth with Reversible Pulpitis. C (Comparison) -Partial Pulpotomy in teeth with Reversible Pulpitis. O (Outcome) -Assessment of clinical \& radiographic success at 6 and 12 months follow up -Assessment of pain experience at baseline, post-operatively every 24 hours for 1 week In extremely deep lesions, the dental pulp is often inflamed or at risk of microbial contamination, therefore requiring timely and precise intervention in order to preserve pulp vitality. In such cases, the removal of the superficial 2-3 mm of inflamed pulp tissue can help maintain the health of the remaining pulpal tissue. Duncan and other researchers have emphasized the importance of assessing both caries depth and pulpal status for deciding the effective treatment plan. Although numerous studies have investigated the outcomes of Direct Pulp Capping (DPC) and Partial Pulpotomy separately \& have included cases based on caries depth \& pulpal status, such as reversible pulpitis. However, there remains a notable lack of comparative clinical studies directly evaluating partial pulpotomy and direct pulp capping under standardized conditions involving extremely deep carious lesions with pulpal status as reversible pulpitis. Hence, this clinical trial aims to assess and compare the clinical and radiographic outcome of Direct Pulp Capping and Partial Pulpotomy in extremely deep caries with reversible pulpitis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Direct Pulp Capping in Reversible Pulpitis | Experimental | Procedure: Direct pulp capping with MTADirect Pulp Capping will be performed on carious pulp exposure after establishing a clinical diagnosis of symptomatic reversible pulpitis based on history of pain exacerbated by cold stimuli and subsides on removal of stimuli compared to normal teeth and which is reproducible using cold testing. |
| Partial Pulpotomy in Reversible Pulpitis | Active comparator | Procedure: Partial Pulpotomy in Reversible PulpitisPartial Pulpotomy will be performed on carious pulp exposure after establishing a clinical diagnosis of symptomatic reversible pulpitis based on history of pain exacerbated by cold stimuli and subsides on removal of stimuli compared to normal teeth and which is reproducible using cold testing. |
Who may qualify
- Ages
- 15 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (6 listed)
- Patients aged 15-40 years.
- Mature permanent mandibular molars with extremely deep caries on radiograph, giving positive response to pulp sensibility test.
- Pulpal bleeding can be controlled within 10 minutes
- Patients having normal periapical status with periapical index (PAI) score ≤ 2
- Periodontally healthy teeth
Key exclusion criteria (12 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 Reversible PulpitisProcedure/Surgery: Outcome of Partial Pulpotomy in teeth with clinical signs indicative of Reversible Pulpitis with extremely deep caries. After caries removal and pulp exposure , 2-3 mm of pulp tissue will be amputated and the pulpal wound irrigated with 3% NaOCl. Bleeding will be controlled by placing a cotton pellet soaked in 3% NaOCl over the pulpal wound for 2-3 minutes, repeated if required. This will be followed by capping with a 2-3 mm layer of MTA in both the groups. A layer of RMGIC will then be placed over the MTA, and the tooth will be permanently restored with composite resin. | Procedure or surgery | Partial Pulpotomy in Reversible Pulpitis |
| Direct pulp capping with MTAOutcome of direct pulp capping in teeth with clinical signs indicative of reversible pulpitis. After caries removal and pulp exposure 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. Followed by capping with MTA, a layer of RMGIC will be placed over the MTA. Then the tooth will be permanently restored with composite resin. | Procedure or surgery | Direct Pulp Capping in Reversible Pulpitis |
Primary outcome
Success rate at 1 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.
1 secondary outcome
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
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 23 Dec 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 Reversible Pulpitis and Direct pulp capping with MTA in people with Reversible Pulpitis and Extremely Deep Caries, 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 6 inclusion and 12 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: opening soon, as of the sponsor's last update on 23 Dec 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 1 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 23 Dec 2025.