Outcome of Partial Pulpotomy in Moderate and Severe Pulpitis

NCT ID: NCT07123025

Last Updated: 2025-08-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-04-18

Study Completion Date

2027-04-18

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

1. Permanent mature molars with Moderate Pulpitis
2. Permanent mature molars with Severe Pulpitis

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Moderate Pulpitis Severe Pulpitis Extremely Deep Caries

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Partial Pulpotomy in Moderate Pulpitis

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.

Group Type EXPERIMENTAL

Partial Pulpotomy in Moderate Pulpitis

Intervention Type PROCEDURE

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 Pulpitis

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

Group Type ACTIVE_COMPARATOR

Partial Pulpotomy in Severe Pulpitis

Intervention Type PROCEDURE

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Partial Pulpotomy in Moderate Pulpitis

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.

Intervention Type PROCEDURE

Partial Pulpotomy in Severe Pulpitis

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

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

1. Patients aged 15-40 years.
2. Mature permanent mandibular molars with extremely deep caries on radiograph, giving positive response to pulp sensibility test.
3. 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.
4. Pulpal bleeding can be controlled within 10 minutes
5. Patients having normal periapical status with periapical index (PAI) score ≤ 2
6. Periodontally healthy teeth
7. Positive response to pulp sensibility test

Exclusion Criteria

1. Non restorable teeth
2. Negative response to vitality testing
3. Presence of sinus tract or soft tissue swelling
4. Absence of deep carious lesions radiographically
5. Radiographic signs of internal or external root resorption
6. Patient had moderate to severe pain, but preferred root canal treatment
7. Presence of sound dentin over pulp and pulp not exposed intraoperatively
8. Pulp haemorrhage could not be arrested within 10 minutes.
9. Necrotic pulp evident upon exposure
10. Pregnant women
11. Absence of antagonist teeth
Minimum Eligible Age

15 Years

Maximum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Postgraduate Institute of Dental Sciences Rohtak

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Dr. Pankaj Sangwan, MDS

Role: PRINCIPAL_INVESTIGATOR

PGIDS, Rohtak, Haryana 124001

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

PGIDS Rohtak

Rohtak, Haryana, India

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

India

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Dr. Pankaj Sangwan, MDS

Role: CONTACT

9996112202

Dr. Prerna Yadav, PG student

Role: CONTACT

9763276071

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Dr. Pankaj Sangwan, MDS

Role: primary

9996112202

Dr. Prerna Yadav, PG student

Role: backup

9763276071

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

Prerna Yadav

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Pulpotomy vs Pulpectomy Outcome.
NCT02727088 UNKNOWN NA
Partial Pulpotomy on Caries Free Human Teeth
NCT01420718 COMPLETED PHASE2/PHASE3