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Outcome of Partial Pulpotomy in Moderate and Severe Pulpitis

P

Postgraduate Institute of Dental Sciences Rohtak

Status

Enrolling

Conditions

Severe Pulpitis
Extremely Deep Caries
Moderate Pulpitis

Treatments

Procedure: Partial Pulpotomy in Moderate Pulpitis
Procedure: Partial Pulpotomy in Severe Pulpitis

Study type

Interventional

Funder types

Other

Identifiers

NCT07123025
Prerna Yadav

Details and patient eligibility

About

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

Full 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.

Enrollment

120 estimated patients

Sex

All

Ages

15 to 40 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Non-Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

120 participants in 2 patient groups

Partial Pulpotomy in Moderate Pulpitis
Experimental group
Description:
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.
Treatment:
Procedure: Partial Pulpotomy in Moderate Pulpitis
Partial Pulpotomy in Severe Pulpitis
Active Comparator group
Description:
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
Treatment:
Procedure: Partial Pulpotomy in Severe Pulpitis

Trial contacts and locations

1

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Central trial contact

Dr. Prerna Yadav, PG student; Dr. Pankaj Sangwan, MDS

Data sourced from clinicaltrials.gov

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