Clinical and Radiographic Assessment of Nano-Bioactive Glass Combined With I-PRF Scaffold in Vital Pulp Treatments in Mandibular Molars With Closed Apices

Study Overview
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Brief Summary
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Clinical, Radiographic and pain assessment of Vital pulp treatment in patients suffering from irreversible pulpitis in mature permanent molars. Total pulpotomy is investigated using I-prf only vs I-prf mixed with Nano-bioactive glass.

Official Title
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Clinical and Radiographic Assessment of Nano-Bioactive Glass Combined With I-PRF Scaffold in Vital Pulp Treatments in Mandibular Molars With Closed Apices: A Triple Blinded Randomized Controlled Trial

Conditions
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Vital Pulp Treatment in Mature Permanent Teeth With Irreversible Pulpitis

Intervention / Treatment
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* Procedure: Total pulpotomy with I-prf mixed with Nano-bioactive glass


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients suffering from Symptomatic irreversible pulpitis in mature mandibular molars only will be involved. Tooth should give positive response to cold test Haemostasias should be achieved after total pulpotomy The tooth is restorable and free from advanced periodontal disease, cracks and splits. Patients should be free from any systemic disease that may affect normal healing and predictable outcome. Patients who will agree to the consent and will commit to follow-up period. Patients with mature root apices Patients with no internal or external resorption and no periapical lesions Soft tissues around the tooth are normal with no swelling or sinus tract. Exclusion Criteria: Patients with immature roots. Haemostasias after 10 minutes can not be controlled after total pulpotomy Patients with any systemic disease that may affect normal healing. Patients with periapical lesions or infections. Pregnant females. Patients who could/would not participate in a 6 months follow-up. Patients with fistula or swelling Patients with necrotic pulp. Patients with old age.

Ages Eligible for Study
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Minimum Age: 14 Years
Maximum Age: 32 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: Total Pulpotomy in mature permanent teeth treated with Nano-bioactive glass mixed with I-PRF
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Total pulpotomy with I-PRF only<br>Total pulpotomy is done in mature permanent molars followed by I-prf application. Topped with BC putty for coronal seal, RMGI and restored with composite as final restoration | Procedure: Total pulpotomy with I-prf mixed with Nano-bioactive glass<br>* Total pulpotomy is done in mature permanent molars followed by I-prf mixed with Nano-Bioactive glass application. Topped with BC putty for coronal seal, RMGI and restored with composite as final restoration<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical , Radiographic and Success rate | Presence or absence of clinical signs and symptoms + Radiographic periapical assessment + success rate based on Radiographic findings | 6 month follow up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain intensity | VAS used to record daily pain intensity | Within the first 24 hrs upto the 7th day |