Concentrated Growth Factor Versus Platelet Rich Fibrin in Revitalization of Necrotic Young Permanent Incisors

NCT05522270 | Unknown

• 1 other identifier: 320
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

Brief Summary

Regenerative endodontic procedures (REPs) are the most recent proposal to manage immature permanent teeth with necrotic pulps. So in this study, the investigator will evaluate the clinical and radiographical revitalization success in necrotic young permanent anterior teeth of participants by using Concentrated Growth Factor versus Platelet-Rich Fibrin

Conditions

Necrotic Pulp

Outcome Measures

Primary Outcomes (2)

• Clinical success rate

  Regaining tooth vitality with electric pulp testing Clinical examination includes pain absence, normal tooth mobility, and no sensitivity to percussion

  one year

• Radiographic success using Periapical index (PAI)

  Criteria of PAI scores: score "1" normal periapical structure score "2" small changes in bone structures score "3" changes in bone structure with some mineral loss score "4" periodontitis with well-defined radiolucent area score "5" severe periodontitis with exacerbating features

  one year

Study Arms (2)

revitalization by concentrated growth factor

EXPERIMENTAL

modified platelet concentrate

Procedure: revitalization by concentrated growth factor

revitalization by platelet rich fibrin

ACTIVE COMPARATOR

platelet concentrate

Procedure: revitalization by concentrated growth factor

Interventions

revitalization by concentrated growth factor PROCEDURE

modified platelet concentrate

Also known as: revitalization by platelet rich fibrin

revitalization by concentrated growth factor; revitalization by platelet rich fibrin

Eligibility Criteria

• Age: 6 Years - 11 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Healthy patients with immature permanent incisors
• Presence of clinical signs and symptoms of necrosis or chronic apical periodontitis. The chronic apical periodontitis signs and symptoms include little discomfort with intermittent episodes of pus discharge through the sinus tract.

You may not qualify if:

• \. Abnormal tooth mobility.
• Positive history of allergic reaction, systemic diseases, severe emotional or behavioral problems.
• Unrestorable teeth
• Abnormal tooth mobility
• Children with systemic, severe behavioral, or emotional problems

Sponsors & Collaborators

• Ahmad Elheeny: lead

MeSH Terms

Conditions

Dental Pulp Necrosis

Condition Hierarchy (Ancestors)

Dental Pulp Diseases; Tooth Diseases; Stomatognathic Diseases; Necrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

ghada tony, doctora

CONTACT

01117902713; ghadatony2003@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: double (participant,outcomes Assessor)
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: clinical professor

Model Details: parallel assignment

Study Record Dates

• First Submitted: August 22, 2022
• First Posted: August 31, 2022
• Study Start: September 1, 2022
• Primary Completion: May 1, 2023
• Study Completion: July 1, 2023
• Last Updated: August 31, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: 12 months