Assessment of L-PRF, Nanohydroxyapatite Combined With L-PRF Using Pulpotomy in Mature Mandibular First Molars

NCT06613932 — Not applicable, Unknown, 45 participants, Future University in Egypt

ClinicalTrials Daily · Areas · Conditions · Drugs · Sponsors ·

Clinical and Radiographic Assessment of L-PRF, Nanohydroxyapatite Material Combined With L-PRF Scaffold in Vital Pulp Therapy. Treatments in Mandibular First Molars With Closed Apices "Randomized Controlled Trial"

Registry	NCT06613932
Status	Unknown
Phase	Not applicable
Study type	Interventional; randomized, parallel, masking: double, treatment
Enrollment	45 (Estimated)
Sponsor	Future University in Egypt (Other)
Conditions	Irreversible Pulpitis
Interventions	pulpotomy (Procedure)
Dates	start 2023-10-30, primary completion 2024-10-30 (estimated), completion 2024-10-30 (estimated), first posted 2024-09-26, last updated 2024-09-26
Locations	1 site in Egypt

-Summary

Clinical and Radiographic Assessment of L-PRF, Nanohydroxyapatite material combined with L-PRF scaffold in Vital pulp Therapy. Treatments in Mandibular First Molars with Closed Apices, Randomized Controlled Trial.

Expand all sections · Collapse all

+Detailed description

pulpotomy by using 3 materials. The first group(control group ) uses hydroxyapatite material as a pulpotomy agent, and the second group uses L-PRF as a pulpotomy agent. the third group uses combined material (L-PRF = Nano hydroxyapatite )as a pulpotomy agent .. then assesses the clinical and radiographic result of the 2 interventions group with control group

+Arms and interventions

Arm	Type	Interventions	Description
hydroxyapatite	Experimental	Procedure: pulpotomy	using hydroxyapatite as a pulpotomy agent and reviewing its clinical and radiographic performance compared to the other groups
L-PRF	Experimental	Procedure: pulpotomy	using L-PRF as a pulpotomy agent and assessing the clinical and radiographic result compared to other groups
L-PRF combined with Nano-hydroxyapatite	Experimental	Procedure: pulpotomy	using the combined material (nanohydroxyapatite mixed to L-PRF ) and assessing the clinical and radiographic result compared to other groups

pulpotomy (Procedure), also known as vital pulp therapy: removal of the coronal pulp tissue and preservation of the radicular portion to ensure continuation of growth and vitality of tooth structure

+Outcome measures

Primary outcomes

post operative Pain assessment [6, 12, 24, 72hours and 7 days after treatment]: Pain evaluations were conducted preoperatively with numerical rating scale ( a verbal or writing determination of a pain level on a scale from 0 to 10, in which 0 represents no pain and 10 represents excruciating pain .

Secondary outcomes

Dentine bridge formation [12 months post operative]: evaluating the thickness of dentine bridge formed after the procedure by comparing immediate post operative CBCT with the one year follow up scans

+Eligibility

Sex: All, ages: 15 Years to 30 Years, accepts healthy volunteers

Inclusion criteria:

Patients should be free from any systemic disease. Patients of either gender aged from 15-30. Patients will agree to the consent and will commit to a follow-up period. Soft tissues around the tooth are normal with no swelling or sinus tract. The tooth is restorable tooth has signs and symptoms of irreversible pulpitis of the mature root The tooth doesn\&#39;t contain any internal or external resorption or periapical lesions.

The tooth should give a positive response to the cold test.

Exclusion criteria:

Pregnant and lactating females. Patients with Mental disturbance. Patients who could/would not participate in a 6-month follow-up. A tooth with immature roots. Patients with necrotic pulp.• tooth with periapical lesions or infections. Soft tissue having fistula or swelling Homoeostasis after 10 minutes can not be controlled after total pulpotomy

+Locations (1)

Facility	City	Country	Status
future university in Egypt	Cairo, New Cairo	Egypt	Recruiting

+Investigators

wael K hussein, professor, Study director, future