Clinical trial NCT06433245: Outcome Following Use of Different Concentrations of NaOCl as Wound Lavage and Hemostatic Agent in Partial Pulpotomy
Official title: Outcome Following Use of Different Concentrations of Sodium Hypochlorite as Wound Lavage and Hemostatic Agent in Partial Pulpotomy: A Randomised Control Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Irreversible Pulpitis
Extremely Deep Caries
Partial Pulpotomy
Keywords: partial pulpotomy
sodium hypochlorite
mature permanent mandibular molars
hemostatic agent
Lead sponsor: Postgraduate Institute of Dental Sciences Rohtak
Sponsor class: OTHER
First posted: 2024-05-29
Enrollment: 116
Sex: ALL
Minimum age (years): 15
Maximum age (years): 40
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this randomised control trial is to compare the effect of different concentrations of NaOCl on outcome of partial pulpotomy in teeth with clinical signs indicative of irreversible pulpitis.

The main question it aims to answer are:

1. clinical and radiographic outcome of partial pulpotomy following use of 5% and 3% NaOCl in mature permanent teeth with clinical signs indicative of irreversible pulpitis.
2. OHRQoL and pain experience after use of 5% and 3% NaOCl during partial pulpotomy in teeth with clinical signs indicative of irreversible pulpitis.

Detailed description: TITLE :- Outcome following use of different concentrations of NaOCl as wound lavage and hemostatic agent in partial pulpotomy: A Randomised control trial.

Question it aims to answer:

Does pulpal lavage using 3% and 5% sodium hypochlorite have comparable effect on outcome of partial pulpotomy in mature permanent teeth with clinical signs of irreversible pulpitis? P (Population) -Mature permanent mandibular molars with signs of irreversible pulpitis.

I (Intervention) - 5% NaOCl C (Comparison) - 3% NaOCl O (Outcome) - 1. Assessment of clinical and radiographic success at 12 months of follow up.

2. Assessment of OHRQoL and pain experience at baseline, post-operatively every 24 hours for 1 week and OHRQoL at 6 and 12 months.

In literature pertaining to vital pulp therapy procedures, there is often a focus on comparing various materials or treatment methodologies. However, the use of sodium hypochlorite, holds significant importance in ensuring the successful outcome of the procedure. The previous studies indicate that the use of NaOCl presents as a confounding factor, compounded by variations among operators in their choice of high and low concentrations of NaOCl.So, there is a pressing need for a direct comparative analysis to assess the influence of varying sodium hypochlorite concentrations on the overall efficacy and success rates of vital pulp therapy procedures.

Eligibility criteria: Inclusion Criteria:

1. Mature permanent mandibular molars.
2. Teeth with clinical diagnosis of symptomatic irreversible pulpitis
3. Patients having normal periapical status with periapical index (PAI) score ≤ 2
4. Periodontally healthy teeth
5. Patients having physical status of class 1 or 2 according to ASA classification
6. Pulpal bleeding can be controlled within 6 minutes.
7. Presence of extremely deep carious lesion on radiograph -

Exclusion Criteria:

1) Non restorable teeth 2) Necrotic pulp evident upon exposure 3) Negative response to vitality test 4) Presence of sinus tract 5) Presence of soft tissue swelling 6) Radiographic signs of internal or external root resorption 7) Pregnant women

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Primary outcomes:
measure: Clinical success rate
timeFrame: baseline to 12 months
measure: 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 h, 2, 3, 4, 5, 6 and 7 days after the treatment, and then at 6 and 12 months.
Other outcomes:
Locations:
city: Rohtak
country: India
facility: PIGDS
state: Haryana
Study officials:
affiliation: PGIDS, Rohtak, Haryana 124001
name: Dr. Sanjay Tewari, MDS
role: STUDY_DIRECTOR
References: