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

Not Applicable

Completed

• Conditions: Irreversible Pulpitis; Partial Pulpotomy

• Registration Number: NCT06768567
• Lead Sponsor: Postgraduate Institute of Dental Sciences Rohtak

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.

Study Timeline

• Study Start: 2023-06-01
• Status Verified: 2025-01
• Study First Submitted: 2025-01-03
• Study First Submitted QC: 2025-01-09
• Study First Posted: 2025-01-10
• Primary Completion: 2025-01-31
• Study Completion: 2025-01-31
• Last Update Submitted: 2025-04-27
• Last Update Posted: 2025-04-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 132

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
1.Clinical success rate	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	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 Outcome Measures

Name	Time	Method
Post Operative Pain	Baseline to 7 days]	To assess incidence and intensity of pain postoperatively at every 24 hours till 7 days using Visual analogue Scale of 0 to 100 millimeter line. Score 0 means no pain and Score100 means maximum pain. To assess incidence and intensity of pain postoperatively at every 24 hours till 7 days using Visual analogue Scale of 0 to 100 millimeter line. Score 0 means no pain and Score 100 means maximum pain
OHRQoL assessment	baseline and at 24 hours, day 2, day 3, day4, day 5, day 6 and day 7 after the treatment.	OHIP-14 questionnare will be used to assess the quality of life.It consists of questionnaire in seven dimensions: functional limitation, physical pain, psychological discomfort, physical disability, psychological disability, social disability, and handicap. It will be scored using a Lickert scale: never=0; hardly ever=1; occasionally=2; fairly often=3; very often=4. Total score will be calculated ranging from 0-56, with higher score denoting the worst OHRQoL

Trial Locations

Locations (1)

PGIDS; 🇮🇳 Rohtak, Haryana, India