Comparing different concentrations of sodium hypochlorite for treating irreversible pulpitis in teeth
Outcome Following Use of Different Concentrations of Sodium Hypochlorite as Wound Lavage and Hemostatic Agent in Partial Pulpotomy: A Randomised Control Trial
This study is testing whether using 3% or 5% sodium hypochlorite can help treat irreversible pulpitis in adult molars and improve patients' comfort and quality of life after the procedure.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 116 (estimated) |
| Ages | 15 Years to 40 Years |
| Sex | All |
| Sponsor | Postgraduate Institute of Dental Sciences Rohtak Academic / other |
| Locations | 1 site (Rohtak, Haryana) |
| Trial ID | NCT06433245 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to evaluate the effectiveness of 3% versus 5% sodium hypochlorite (NaOCl) as a wound lavage and hemostatic agent during partial pulpotomy in mature permanent mandibular molars diagnosed with irreversible pulpitis. Participants will undergo a randomized control trial where clinical and radiographic outcomes will be assessed at 12 months, alongside evaluations of oral health-related quality of life (OHRQoL) and pain experiences at various intervals post-treatment. The study seeks to clarify the impact of different NaOCl concentrations on treatment success and patient comfort.
Who should consider this trial
Good fit: Ideal candidates include patients with mature permanent mandibular molars exhibiting clinical signs of irreversible pulpitis and normal periapical status.
Not a fit: Patients with non-restorable teeth, necrotic pulp, or other significant dental issues will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance the effectiveness of partial pulpotomy treatments, leading to better patient outcomes and reduced pain.
How similar studies have performed: Previous studies have indicated the importance of sodium hypochlorite in vital pulp therapy, but this specific comparative analysis of concentrations is novel.
Eligibility criteria
Show full inclusion / exclusion 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 -
Where this trial is running
Rohtak, Haryana
- Pigds — Rohtak, Haryana, India (Recruiting)
Study contacts
- Study coordinator: Dr. Pankaj Sangwan, MDS
- Email: drps_1@yahoo.co.in
- Phone: 9996112202
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.