- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07460869
Compare Between the Effect of CGF and PRF on Revascularization of Immature Roots of the Mandibular Permanent First Molar
March 4, 2026 updated by: Bothaina Ahmed, Minia University
Concentrated Growth Factor Versus Platelets-rich Fibrin in Revascularization of Immature Necrotic Mandibular First Permanent Molar.
in this study investigators do revascularization technique to promote root growth of immature mandibular first permanent molar by using CGF and PRF from blood sample of patients
Study Overview
Status
Active, not recruiting
Intervention / Treatment
Detailed Description
children 6-8 yrs were selected for this study because the roots of mandibular first permanent molar is not completed.
then access cavity is opened, irrigation protocol is applied, intracanal medication is applied and the cavity is sealed with temporary filling.
after three weeks blood sample is obtained from patients to get CGF and PRF membranes.
temporary filling is removed .
intracanal medication is removed, over instrumentation is done to get some intracanal blood the wait tell blood clot is formed then CGF or PRF is applied on the clot the bio dentine is applied and cavity is sealed with composite restoration
Study Type
Interventional
Enrollment (Actual)
60
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Minya Governorate
-
Minya, Minya Governorate, Egypt, 2422998
- Faculty of Dentistry Minya University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- Children with immature necrotic lower fitrst permanent molar.
- No history of repeated pathosis or cellulitis.
- Patients accept the treatment modality.
- Patient-free from systemic, allergic or genetic problems.
Exclusion Criteria:
- Tooth mobility.
- Teeth with non-restorable crowns.
- Children with facial cellulitis
- Children with draining fistula
- Children with a history of recurrent preapical pathosis
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: CGF and biodentine arm
(control group) Which CGF and bio-dentine are applied to the immature pulp of the first permanent molar
|
Compare the effect of CGF and PRF in the revascularization of immature mandibular first permanent molar using bio-dentine
|
|
Active Comparator: PRF and biodentine arm
PRF and bio-dentine are applied on immature pulp of first permanent molar
|
Compare the effect of CGF and PRF in the revascularization of immature mandibular first permanent molar using bio-dentine
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
root growth
Time Frame: 18 months
|
change root length
|
18 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Ahmed elheeny, professor of Pediatric and Com, unaffilliaed
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 10, 2025
Primary Completion (Estimated)
July 10, 2026
Study Completion (Estimated)
July 10, 2027
Study Registration Dates
First Submitted
February 13, 2026
First Submitted That Met QC Criteria
March 4, 2026
First Posted (Actual)
March 10, 2026
Study Record Updates
Last Update Posted (Actual)
March 10, 2026
Last Update Submitted That Met QC Criteria
March 4, 2026
Last Verified
August 1, 2025
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- Bothaina A. Gado
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Plan Description
CONCENTRATED GROWTH FACTOR VERSUS PLATELETS-RICH FIBRIN IN REVASCULARIZATION OF IMMATURE NECROTIC MANDIBULAR FIRST PERMANENT MOLAR
IPD Sharing Time Frame
2027
IPD Sharing Access Criteria
dental students and researchers in denta field
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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