Clinical trial NCT06768567: Evaluation of Hemostasis Time on Partial Pulpotomy in Teeth With Clinical Signs Indicative of Irreversible Pulpitis
Official title: Evaluation of Effect of Hemostasis Time on Partial Pulpotomy in Mature Permanent Teeth With Clinical Signs Indicative of Irreversible Pulpitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Irreversible Pulpitis
Partial Pulpotomy
Keywords: partial pulpotomy
hemostatsis time
Lead sponsor: Postgraduate Institute of Dental Sciences Rohtak
Sponsor class: OTHER
First posted: 2025-01-10
Enrollment: 132
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: 1.Clinical success rate
timeFrame: baseline to 12 months
measure: 2.Radiographic success rate
timeFrame: baseline to 12 months
Secondary outcomes:
measure: Post Operative Pain
timeFrame: Baseline to 7 days]
measure: OHRQoL assessment
timeFrame: baseline and at 24 hours, day 2, day 3, day4, day 5, day 6 and day 7 after the treatment.
Other outcomes:
Locations:
city: Rohtak
country: India
facility: PGIDS
state: Haryana
Study officials:
affiliation: PGIDS, Rohtak, Haryana 124001
name: Dr. Pankaj Sangwan, MDS
role: STUDY_DIRECTOR
References: