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

NCT06613932 | Recruiting DMC

• 1 other identifier: (37)11-2023
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Irreversible Pulpitis

Outcome Measures

Primary Outcomes (1)

• post operative Pain assessment

  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 .

  6, 12, 24, 72hours and 7 days after treatment

Secondary Outcomes (1)

• Dentine bridge formation

  12 months post operative

Study Arms (3)

hydroxyapatite

EXPERIMENTAL

using hydroxyapatite as a pulpotomy agent and reviewing its clinical and radiographic performance compared to the other groups

Procedure: pulpotomy

L-PRF

EXPERIMENTAL

using L-PRF as a pulpotomy agent and assessing the clinical and radiographic result compared to other groups

Procedure: pulpotomy

L-PRF combined with Nano-hydroxyapatite

EXPERIMENTAL

using the combined material (nanohydroxyapatite mixed to L-PRF ) and assessing the clinical and radiographic result compared to other groups

Procedure: pulpotomy

Interventions

pulpotomy PROCEDURE

removal of the coronal pulp tissue and preservation of the radicular portion to ensure continuation of growth and vitality of tooth structure

Also known as: vital pulp therapy

L-PRF; L-PRF combined with Nano-hydroxyapatite; hydroxyapatite

Eligibility Criteria

• Age: 15 Years - 30 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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\'t contain any internal or external resorption or periapical lesions.
• The tooth should give a positive response to the cold test.

You may not qualify if:

• 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

Sponsors & Collaborators

• Future University in Egypt: lead

Study Sites (1)

future university in Egypt

Cairo, New Cairo, 11835, Egypt

RECRUITING

MeSH Terms

Interventions

Pulpotomy

Intervention Hierarchy (Ancestors)

Endodontics; Dentistry

Study Officials

• wael K hussein, professor

  future

  STUDY DIRECTOR

Central Study Contacts

nada A metwally, master

CONTACT

01122289353; nadaaymaan55@gmail.com

toka A metwally, bachelor's

CONTACT

01068681660

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principal investigator

Study Record Dates

• First Submitted: August 16, 2024
• First Posted: September 26, 2024
• Study Start: October 30, 2023
• Primary Completion: October 30, 2024
• Study Completion: October 30, 2024
• Last Updated: September 26, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)