- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07319494
Advanced PRF vs PRF for Gap Filling in Immediate Implants (A-PRF vs PRF)
Comparison of Advanced Platelet Rich Fibrin Versus Platelet Rich Fibrin as a Gap Filling Material in Immediate Implant Placement
Study type: Clinical Trial
Goal:
The goal of this clinical trial is to learn if Advanced Platelet-Rich Fibrin (A-PRF) versus traditional Platelet-Rich Fibrin (PRF) can improve bone healing and soft tissue outcomes in patients undergoing immediate dental implant placement.
Main questions it aims to answer:
Does A-PRF provide greater buccal bone preservation compared to PRF after immediate implant placement?
Does A-PRF improve soft tissue healing and reduce postoperative complications compared to PRF?
Comparison group:
Researchers will compare A-PRF to PRF as a gap-filling material in immediate implants to see if A-PRF results in better bone and soft tissue outcomes.
Participants will:
Undergo tooth extraction followed by immediate implant placement
Receive either A-PRF or PRF as the gap-filling material in the implant site
Have CBCT scans at baseline and 6 months to measure bone thickness
Have clinical assessments of soft tissue healing and implant stability
Attend follow-up visits at 1 week, 1 month, 3 months, and 6 months post-surgery
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Al Mansurah, Egypt, 35516
- Delta University for Science and Technology
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- The selected patients has a badly decayed mandibular posterior teeth which are indicated for extraction due to dental causes (periapical abscess, trauma or caries) not periodontal as diagnosed by periapical x-ray.
- Healthy patients who are classified according to the American Society of Anesthesiologists (ASA)(2022) physical status classification as class I.
- Patient age ≥ 20 years old.
- Surgical site with sufficient for implant placement.
- Sufficient interocclusal space for prosthesis.
- Good oral hygiene.
- Patients have thick biotype.
- Patients have socket class I.
Exclusion Criteria:
- Active periodontal diseases and periapical lesions not chronic infections.
- Patients have parafunctional
- History of alcohol or drug dependency, psychological factor that might affect the surgical or prosthodontic treatment.
- Smoking.
- Pregnant patients.
- Patients who are not willing to complete the study.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: PRF Group
Participants in this arm will undergo tooth extraction followed by immediate implant placement.
The extraction socket will be filled with traditional Platelet-Rich Fibrin (PRF) as the gap-filling material.
|
Arm 2: Platelet-Rich Fibrin (PRF) Participants will have a tooth extracted, the socket cleaned, and traditional PRF prepared from their blood placed in the socket as a gap-filling material before immediate implant placement.
Follow-up visits will assess bone and soft tissue healing and implant stability.
|
|
Experimental: A-PRF Group
Participants in this arm will undergo tooth extraction followed by immediate implant placement.
The extraction socket will be filled with Advanced Platelet-Rich Fibrin (A-PRF) as the gap-filling material.
|
Arm 1: Advanced Platelet-Rich Fibrin (A-PRF) Participants will have a tooth extracted, the socket cleaned, and A-PRF prepared from their blood placed in the socket as a gap-filling material before immediate implant placement.
Follow-up visits will assess bone and soft tissue healing and implant stability.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Clinical evaluation
Time Frame: 6 month
|
Implant stability will be measured by resonance frequency analysis (RFA) values expressed as implant stability quotient (ISQ) unit at 6 months post-operative
|
6 month
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- DU:024111959
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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