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Evaluation of Hemostasis Time on Partial Pulpotomy in Teeth With Clinical Signs Indicative of Irreversible Pulpitis

P

Postgraduate Institute of Dental Sciences Rohtak

Status

Enrolling

Conditions

Partial Pulpotomy
Irreversible Pulpitis

Treatments

Procedure: effect of hemostasis time on outcome of partial pulpotomy in teeth with clinical signs indicative of irreversible pulpitis.

Study type

Interventional

Funder types

Other

Identifiers

NCT06768567
Vinita yadav

Details and patient eligibility

About

The aim of this prospective study is to investigate the influence of time taken to achieve hemostasis on outcome of partial pulpotomy in teeth with clinical signs indicative of irreversible pulpitis.

OBJECTIVE:-

  1. To evaluate clinical and radiographic success of time taken to achieve hemostasis on outcome of partial pulpotomy in mature permanent teeth with clinical signs indicative of irreversible pulpitis.
  2. To evaluate OHRQoL and pain incidence & severity after partial pulpotomy in teeth with clinical signs indicative of irreversible pulpitis.

Participants will of age group 18 to 45 years will be included and divided into two groups based on hemostasis time:

I(Intervention) - <6minutes C (Comparison) - 6-12 minutes

Full description

TITLE:- Evaluation of hemostasis time on partial pulpotomy in teeth with clinical signs indicative of irreversible pulpitis.

P (Population) - Mature permanent molars with clinical signs of irreversible pulpitis.

I (Intervention) - <6minutes C (Comparison) - 6-12 minutes O (Outcome) - Assessment of clinical and radiographic success at 12 months of follow up .

Assessment of OHRQoL at baseline, post-operatively every 24 hours for 1 week and at 6 and 12 months & incidence and severity of pain at baseline and post-operatively every 24 hours till 1 week.

Time taken to achieve hemostasis has been suggested as a reliable surrogate measure to determine the depth of inflammation in the pulp. In absence of any other intraoperative indicator, it serves as a useful guide to the extent of pulp tissue removal required during pulpotomy. This trial will help formulate evidence based guideline regarding time for hemostasis advisable to achieve optimum success during pulpotomy in teeth with signs indicative of irreversible pulpitis.

Enrollment

130 estimated patients

Sex

All

Ages

18 to 45 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • Mature permanent mandibular molars with carious pulp exposures and signs suggestive of irreversible pulpitis.
  • vital pulp with demonstrable bleeding upon entry.
  • The tooth is restorable.
  • Tooth with mobility and probing depth within normal limits.
  • Soft tissues around the tooth are normal with no swelling or sinus tract.
  • No evidence of chronic apical periodontitis (PAI 1,2)

Exclusion criteria

  • patients who report history of antibiotic intake in past 1 month or analgesic intake in past 3 days.
  • pregnant women.
  • absence of opposing teeth
  • 3rd molars
  • medically compromised patients (ASA II,III,IV,V).
  • Tenderness on percussion positive
  • pathologic mobility

Trial design

Primary purpose

Treatment

Allocation

Non-Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

130 participants in 2 patient groups

Hemostasis time less than 6 minutes
Active Comparator group
Description:
after partial pulpotomy, procedure pulp 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 and time taken to achieve hemostasis will be recorded using stop watch.
Treatment:
Procedure: effect of hemostasis time on outcome of partial pulpotomy in teeth with clinical signs indicative of irreversible pulpitis.
hemostasis time 6 to 12 minutes
Experimental group
Description:
after partial pulpotomy, procedure pulp 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 and time taken to achieve hemostasis will be recorded using stop watch.Root canal therapy will be initiated in cases in which haemostasis is not achieved even after 12 minutes.
Treatment:
Procedure: effect of hemostasis time on outcome of partial pulpotomy in teeth with clinical signs indicative of irreversible pulpitis.

Trial contacts and locations

1

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Central trial contact

Dr. Pankaj Sangwan, MDS; Dr.Vinita yadav

Data sourced from clinicaltrials.gov

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