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Comparative Evaluation of Partial and Complete Pulpotomy in Permanent Molars

P

Postgraduate Institute of Dental Sciences Rohtak

Status

Unknown

Conditions

Pulpitis - Irreversible

Treatments

Procedure: Pulpotomy up to superficial 2-3 mm of pulp chamber
Procedure: Pulpotomy to the level of canal orifices

Study type

Interventional

Funder types

Other

Identifiers

NCT04397315
Dr. Ankita Ramani

Details and patient eligibility

About

This study will compare the outcome of partial pulpotomy and complete pulpotomy in mature permanent molars with clinical signs indicative of irreversible pulpitis

Full description

After thorough history and clinical and radio graphic examination, and confirmation of eligibility for the study, written informed consent will be taken after explaining the procedure and its associated risks and benefits. Clinical diagnosis of irreversible pulpitis will be established based on a history of spontaneous pain or pain exacerbated by cold stimuli and lasting for a few seconds to several hours (lingering pain) compared to control teeth and which is reproducible using cold testing. Once included, study subjects will be randomly allocated to either Complete Pulpotomy group or Partial Pulpotomy group. (Mineral Trioxide Aggregate) MTA will be used as pulpotomy agent. A layer of resin modified Glass Ionomer liner will be placed over the MTA and tooth will be permanently restored with composite resin in second appointment.

Pain analysis will be carried out preoperatively and postoperatively at every 24 hours till 7 days after intervention. All the subjects will be followed up for evaluation of success at every 3 months from baseline to 1 year.

Enrollment

74 estimated patients

Sex

All

Ages

18 to 40 years old

Volunteers

Accepts Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria: Inclusion criteria

  • The patient should be ≥18 years of age.
  • Restorable molar teeth.
  • Tooth should give positive response to pulp sensibility testing.
  • Clinical diagnosis of irreversible pulpitis.
  • Tooth with probing pocket depth and mobility are within normal limits.
  • No signs of pulpal necrosis including sinus tract or swelling.
  • Non-contributory medical history

Exclusion Criteria:

  • Teeth with immature roots.
  • No pulp exposure after caries excavation.
  • Bleeding could not be controlled in 6 minutes.
  • Insufficient bleeding after pulp exposure, the pulp is judged necrotic or partially necrotic.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

74 participants in 2 patient groups

Complete Pulpotomy
Active Comparator group
Description:
In case of complete pulpotomy procedure the exposed pulp tissue will be amputated using sterile bur in high speed hand piece to the level of canal orifices.
Treatment:
Procedure: Pulpotomy to the level of canal orifices
Partial Pulpotomy
Active Comparator group
Description:
In case of partial pulpotomy procedure the exposed pulp tissue will be amputated using a sterile bur in the high speed hand piece to a depth of 2-3 mm.
Treatment:
Procedure: Pulpotomy up to superficial 2-3 mm of pulp chamber

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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