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

Not Applicable

Recruiting

• Conditions: Vital Pulp Treatment in Mature Permanent Teeth With Irreversible Pulpitis
• Interventions: Procedure: Total pulpotomy with I-prf mixed with Nano-bioactive glass

• Registration Number: NCT05876520
• Lead Sponsor: Cairo University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-01-25
• Status Verified: 2023-05
• Study First Submitted: 2023-05-09
• Study First Submitted QC: 2023-05-24
• Last Update Submitted: 2023-05-24
• Study First Posted: 2023-05-25
• Last Update Posted: 2023-05-25
• Primary Completion: 2024-03
• Study Completion: 2024-04

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 28

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Total pulpotomy with I-PRF only	Total pulpotomy with I-prf mixed with Nano-bioactive glass	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

Primary Outcome Measures

Name	Time	Method
Clinical , Radiographic and Success rate	6 month follow up	Presence or absence of clinical signs and symptoms + Radiographic periapical assessment + success rate based on Radiographic findings

Secondary Outcome Measures

Name	Time	Method
Pain intensity	Within the first 24 hrs upto the 7th day	VAS used to record daily pain intensity

Trial Locations

Locations (1)

Noor Mohammed Kamal Eldeen; 🇪🇬 Cairo, Egypt