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Clinical Trials/NCT06768567
NCT06768567
Completed
Not Applicable

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

Postgraduate Institute of Dental Sciences Rohtak1 site in 1 country132 target enrollmentJune 1, 2023

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Irreversible Pulpitis
Sponsor
Postgraduate Institute of Dental Sciences Rohtak
Enrollment
132
Locations
1
Primary Endpoint
1.Clinical success rate
Status
Completed
Last Updated
last year

Overview

Brief Summary

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) - 7-12 minutes

Detailed 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) - 7-12 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 \& 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.

Registry
clinicaltrials.gov
Start Date
June 1, 2023
End Date
January 31, 2025
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Eligibility Criteria

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 .
  • Tenderness on percussion positive
  • pathologic mobility

Outcomes

Primary Outcomes

1.Clinical success rate

Time Frame: baseline to 12 months

Clinical criteria of success:- 1. No pain or 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. Healthy soft tissues around teeth with no swelling, sinus tract.

2.Radiographic success rate

Time Frame: baseline to 12 months

Radiographic success criteria:- 1. No pathosis such as root resorption, furcal pathosis or new periapical pathosis evident on the radiograph. 2. Complete radiographic healing

Secondary Outcomes

  • Post Operative Pain(Baseline to 7 days])
  • OHRQoL assessment(baseline and at 24 hours, day 2, day 3, day4, day 5, day 6 and day 7 after the treatment.)

Study Sites (1)

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