Actively Recruiting

Phase Not Applicable
Age: 15Years - 40Years
All Genders
Healthy Volunteers
ID07123025

Outcome of Partial Pulpotomy in Moderate and Severe Pulpitis in Mature Permanent Molars

Led by Postgraduate Institute of Dental Sciences Rohtak · Updated on 2025-08-28

120

Participants Needed

1

Research Sites

52 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are investigating the outcomes of partial pulpotomy treatment in mature permanent molars diagnosed with moderate or severe pulpitis. The study aims to compare the clinical and radiographic success between these two groups and to evaluate the impact on oral health-related quality of life (OHRQoL) and postoperative pain. Participants will be aged 15 to 40 years and divided into two groups based on the severity of their pulpitis. The study involves performing partial pulpotomy on mature permanent molars after diagnosis of either moderate or severe pulpitis. The procedure includes removing caries, amputating pulp tissue, controlling bleeding with 3% sodium hypochlorite, and capping with mineral trioxide aggregate (MTA) followed by a resin-modified glass ionomer cement (RMGIC) layer. The tooth is then restored permanently with composite resin. Root canal therapy will be started if bleeding cannot be controlled within 10 minutes. Participants will be monitored over a 12-month period with clinical and radiographic assessments at 6 and 12 months to evaluate treatment success. Postoperative pain and oral health quality of life will be recorded daily for 1 week after treatment. The primary outcome is the success rate after one year. The study will also track pain levels and quality of life changes shortly after treatment to understand patient experience. Total follow-up is up to 12 months.

CONDITIONS

Brief Title

Outcome of Partial Pulpotomy in Moderate and Severe Pulpitis

Who Can Participate

Age: 15Years - 40Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients aged 15 to 40 years
  • Mature permanent mandibular molars with very deep cavities seen on X-rays and positive pulp sensibility test
  • For moderate pulpitis: strong, prolonged reaction to cold lasting minutes, possible percussion sensitivity, and manageable dull spontaneous pain
  • For severe pulpitis: severe spontaneous pain triggered by warmth, cold, or touch, often sharp to dull throbbing pain, pain disturbing sleep, and sensitivity to percussion
  • Pulp bleeding can be controlled within 10 minutes
  • Normal periapical status with periapical index score of 2 or less
  • Teeth must be periodontally healthy and respond positively to pulp sensibility test
Not Eligible

You will not qualify if you...

  • Teeth that cannot be restored
  • Negative response to vitality testing
  • Presence of sinus tract or soft tissue swelling
  • No deep carious lesions visible on X-rays
  • Signs of internal or external root resorption on X-rays
  • Patients with moderate to severe pain who prefer root canal treatment
  • Teeth with sound dentin over pulp and no pulp exposure during procedure
  • Pulp bleeding that cannot be stopped within 10 minutes
  • Necrotic pulp found when exposed
  • Pregnant women
  • Missing opposing teeth

AI-Screening

AI-Powered Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - Single treatment visit

Participants receive partial pulpotomy treatment for moderate or severe pulpitis in mature permanent molars. The procedure includes pulp amputation, wound irrigation, bleeding control, capping with MTA and RMGIC, and permanent restoration with composite resin.

1 visit (in-person)

Follow-up

Duration - 12 months

Participants are monitored for clinical and radiographic success, and assessment of oral health-related quality of life and pain experience is conducted post-operatively every 24 hours for 1 week.

Visits at 24 hours, Day 2, Day 3, Day 4, Day 5, Day 6, Day 7, and at 6 and 12 months

Trial Site Locations

Total: 1 location

1

PGIDS Rohtak

Rohtak, Haryana, India, 124001

Actively Recruiting

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Research Team

D

Dr. Pankaj Sangwan, MDS

D

Dr. Prerna Yadav, PG student

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

NON_RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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