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

NCT06768567 | Completed

• 1 other identifier: Vinita yadav
• Study Type: interventional
• Target: 132
• Locations: 1 country
• Sites: 1

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. 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. 2.To evaluate OHRQoL and pain incidence \& severity after partial pulpotomy in teeth with clinical signs indicative of irreversible pulpitis.

Conditions

Irreversible Pulpitis; Partial Pulpotomy

Keywords

partial pulpotomy; hemostatsis time

Outcome Measures

Primary Outcomes (2)

• 1.Clinical success rate

  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.

  baseline to 12 months

• 2.Radiographic success rate

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

  baseline to 12 months

Secondary Outcomes (2)

• 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 Arms (2)

Hemostasis time upto 6 minutes

ACTIVE COMPARATOR

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 minutes and will be repeated if required and time taken to achieve hemostasis will be recorded using stop watch.

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

hemostasis time 7 to 12 minutes

EXPERIMENTAL

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 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.

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

Interventions

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

After caries removal and pulp exposure pulp tissue is amputated and pulpal 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. Teeth in which bleeding will be controlled within 6 mins will be placed in Group A, while those in which it gets controlled between 7 to 12 mins will be included in Group B. Root canal therapy will be initiated in cases in which haemostasis is not achieved even after 12 minutes. Followed by capping with 2-3mm layer of MTA. A layer of RMGIC will be placed over the MTA. Then the tooth will be permanently restored with composite resin.

Hemostasis time upto 6 minutes; hemostasis time 7 to 12 minutes

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

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

Sponsors & Collaborators

• Postgraduate Institute of Dental Sciences Rohtak: lead

Study Sites (1)

PGIDS

Rohtak, Haryana, 124001, India

Location

Study Officials

• Dr. Pankaj Sangwan, MDS

  PGIDS, Rohtak, Haryana 124001

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 3, 2025
• First Posted: January 10, 2025
• Study Start: June 1, 2023
• Primary Completion: January 31, 2025
• Study Completion: January 31, 2025
• Last Updated: April 30, 2025

Record last verified: 2025-01

Locations

IN (1)