Outcome of Partial Pulpotomy in Moderate and Severe Pulpitis

NCT07123025 | Recruiting

• 1 other identifier: Prerna Yadav
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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

Conditions

Moderate Pulpitis; Severe Pulpitis; Extremely Deep Caries

Keywords

partial pulpotomy

Outcome Measures

Primary Outcomes (1)

• success rate at one year

  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.

  Baseline to 12 months

Secondary Outcomes (2)

• Postoperative Pain

  Baseline and at 24 hours, Day 2, Day 3, Day 4, Day 5, Day 6 and Day 7 after the treatment

• OHRQoL assessment

  Baseline and at 24 hours, Day 2, Day 3, Day 4, Day 5, Day 6 and Day 7 after the treatment

Study Arms (2)

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.

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

Procedure: Partial Pulpotomy in Severe Pulpitis

Interventions

Partial Pulpotomy in Moderate Pulpitis 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 Moderate Pulpitis

Partial Pulpotomy in Severe Pulpitis 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

Partial Pulpotomy in Severe Pulpitis

Eligibility Criteria

• Age: 15 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Postgraduate Institute of Dental Sciences Rohtak: lead

Study Sites (1)

PGIDS Rohtak

Rohtak, Haryana, 124001, India

RECRUITING

MeSH Terms

Conditions

Pulpitis

Condition Hierarchy (Ancestors)

Dental Pulp Diseases; Tooth Diseases; Stomatognathic Diseases

Study Officials

• Dr. Pankaj Sangwan, MDS

  PGIDS, Rohtak, Haryana 124001

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Dr. Pankaj Sangwan, MDS

CONTACT

9996112202; drps_1@yahoo.co.in

Dr. Prerna Yadav, PG student

CONTACT

9763276071; viks0267@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 23, 2025
• First Posted: August 14, 2025
• Study Start: April 18, 2025
• Primary Completion: April 18, 2026
• Study Completion (Estimated): April 18, 2027
• Last Updated: August 28, 2025

Record last verified: 2025-08

Locations

IN (1)