Back to resultsConcentrated Growth Factor Versus Platelet Rich Fibrin in Revitalization of Necrotic Young Permanent Incisors
Primary Purpose
Necrotic Pulp
Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
revitalization by concentrated growth factor
Sponsored by
About this trial
This is an interventional treatment trial for Necrotic Pulp
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria
1. 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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
revitalization by concentrated growth factor
revitalization by platelet rich fibrin
Arm Description
modified platelet concentrate
platelet concentrate
Outcomes
Primary Outcome Measures
Clinical success rate
Regaining tooth vitality with electric pulp testing Clinical examination includes pain absence, normal tooth mobility, and no sensitivity to percussion
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
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05522270
Brief Title
Concentrated Growth Factor Versus Platelet Rich Fibrin in Revitalization of Necrotic Young Permanent Incisors
Official Title
Concentrated Growth Factor Versus Platelet Rich Fibrin in Revitalization of Necrotic Young Permanent Incisors
Study Type
Interventional
2. Study Status
Record Verification Date
August 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
September 1, 2022 (Anticipated)
Primary Completion Date
May 1, 2023 (Anticipated)
Study Completion Date
July 1, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Ahmad Elheeny
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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
Detailed Description
has been entered
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Necrotic Pulp
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
parallel assignment
Masking
ParticipantOutcomes Assessor
Masking Description
double (participant,outcomes Assessor)
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
revitalization by concentrated growth factor
Arm Type
Experimental
Arm Description
modified platelet concentrate
Arm Title
revitalization by platelet rich fibrin
Arm Type
Active Comparator
Arm Description
platelet concentrate
Intervention Type
Procedure
Intervention Name(s)
revitalization by concentrated growth factor
Other Intervention Name(s)
revitalization by platelet rich fibrin
Intervention Description
modified platelet concentrate
Primary Outcome Measure Information:
Title
Clinical success rate
Description
Regaining tooth vitality with electric pulp testing Clinical examination includes pain absence, normal tooth mobility, and no sensitivity to percussion
Time Frame
one year
Title
Radiographic success using Periapical index (PAI)
Description
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
Time Frame
one year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
11 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria
1. 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
ghada tony, doctora
Phone
01117902713
Email
ghadatony2003@gmail.com
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Time Frame
12 months
Learn more about this trial
Concentrated Growth Factor Versus Platelet Rich Fibrin in Revitalization of Necrotic Young Permanent Incisors
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