Actively Recruiting

Phase Not Applicable
Age: 15Years - 30Years
All Genders
Healthy Volunteers
ID06613932

Clinical and Radiographic Assessment of L-PRF, Nanohydroxyapatite Combined With L-PRF Scaffold in Vital Pulp Therapy for Mature Mandibular First Molars

Led by Future University in Egypt · Updated on 2024-09-26

45

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

This research aims to evaluate the clinical and radiographic effects of different materials used in pulpotomy treatment for mature mandibular first molars with irreversible pulpitis. The study compares three groups: one using hydroxyapatite, another using L-PRF (Leukocyte-Platelet Rich Fibrin), and the third using a combination of nanohydroxyapatite mixed with L-PRF. The goal is to assess how these materials perform in preserving tooth vitality and promoting healing. Participants will receive pulpotomy treatment where the coronal pulp tissue is removed while preserving the root pulp to maintain tooth vitality. Three groups will be treated differently: one with hydroxyapatite, another with L-PRF, and the third with the combined nanohydroxyapatite and L-PRF material. The study is randomized and double-blinded, comparing clinical and radiographic outcomes among the groups. During the study, participants will be monitored for postoperative pain at 6, 12, 24, and 72 hours, and again at 7 days after treatment. Long-term evaluation includes checking for dentine bridge formation at 12 months post-treatment. Follow-up visits will assess healing and any clinical or radiographic changes. The total participation period involves regular assessments to measure treatment effects and safety.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 15Years - 30Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients aged 15 to 30 years
  • Patients of any gender
  • Patients free from any systemic disease
  • Patients who agree to consent and commit to follow-up
  • Normal soft tissues around the tooth with no swelling or sinus tract
  • Restorable tooth with signs and symptoms of irreversible pulpitis and mature roots
  • Tooth shows positive response to cold test
  • No internal or external resorption or periapical lesions
Not Eligible

You will not qualify if you...

  • Pregnant or lactating females
  • Patients with mental disturbance
  • Patients unable or unwilling to participate in 6-month follow-up
  • Tooth with immature roots
  • Patients with necrotic pulp
  • Tooth with periapical lesions or infections
  • Soft tissue with fistula or swelling
  • Inability to control bleeding after 10 minutes post-pulpotomy

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - Single treatment visit

Participants undergo pulpotomy using one of three materials: hydroxyapatite, L-PRF, or a combination of L-PRF and nanohydroxyapatite.

1 visit (in-person)

Follow-up

Duration - Up to 12 months post treatment

Participants are assessed for post-operative pain and dentine bridge formation after treatment.

Visits at 6, 12, 24, 72 hours, 7 days, and 12 months after treatment

Trial Site Locations

Total: 1 location

1

future university in Egypt

Cairo, New Cairo, Egypt, 11835

Actively Recruiting

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Research Team

N

nada A metwally, master

T

toka A metwally, bachelor's

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

3

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