Outcome Following Use of Different Concentrations of NaOCl as Wound Lavage and Hemostatic Agent in Partial Pulpotomy
NCT ID: NCT06433245
Last Updated: 2025-01-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
116 participants
INTERVENTIONAL
2024-05-23
2025-12-23
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Control: 3% sodium hypochlorite
After partial pulpotomy procedure, pulp wound will be irrigated with 3% sodium hypochlorite and haemostasis will be achieved by placing the cotton pellet soaked with 3% sodium hypochlorite on the amputated pulp.
effect of 3% and 5% sodium hypochlorite on outcome of partial pulpotomy in teeth with clinical signs indicative of irreversible pulpitis.
After caries removal and pulp exposure pulp tissue is amputated and hemostasis is achieved with 3% sodium hypochlorite in control group and 5% sodium hypochlorite in experimental group 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.
Test: 5% sodium hypochlorite
After partial pulpotomy procedure, pulp wound will be irrigated with 5% sodium hypochlorite and haemostasis will be achieved by placing the cotton pellet soaked with 5% sodium hypochlorite on the amputated pulp.
effect of 3% and 5% sodium hypochlorite on outcome of partial pulpotomy in teeth with clinical signs indicative of irreversible pulpitis.
After caries removal and pulp exposure pulp tissue is amputated and hemostasis is achieved with 3% sodium hypochlorite in control group and 5% sodium hypochlorite in experimental group 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.
Interventions
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effect of 3% and 5% sodium hypochlorite on outcome of partial pulpotomy in teeth with clinical signs indicative of irreversible pulpitis.
After caries removal and pulp exposure pulp tissue is amputated and hemostasis is achieved with 3% sodium hypochlorite in control group and 5% sodium hypochlorite in experimental group 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.
Eligibility Criteria
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Inclusion Criteria
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
\-
15 Years
40 Years
ALL
Yes
Sponsors
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Postgraduate Institute of Dental Sciences Rohtak
OTHER
Responsible Party
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Principal Investigators
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Dr. Sanjay Tewari, MDS
Role: STUDY_DIRECTOR
PGIDS, Rohtak, Haryana 124001
Locations
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PIGDS
Rohtak, Haryana, India
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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Ridhi Karwal
Identifier Type: -
Identifier Source: org_study_id
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