- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07445776
Extended Platelet Rich Fibrin Versus Allograft as Space Filling Material
February 25, 2026 updated by: Hala Elnaggar, Mansoura University
Extended Platelet Rich Fibrin Versus Allograft as Space Filling Material in Immediate Dental Implant Placement
Twenty-eight patients seeking prosthetic replacement of non-restorable single rooted maxillary teeth by dental implant will be selected from the outpatient Clinic of Oral and Maxillofacial Surgery Department, Faculty of Dentistry, Mansoura University
Study Overview
Status
Completed
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
28
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
-
-
-
Al Mansurah, Egypt, 002
- Faculty of Dentistry, Mansoura 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
- Adult
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- Patients with badly destructed teeth due to trauma or caries.
- Patients willing to complete the study follow up intervals.
- Patients with good oral hygiene.
- Adequate inter-arch space that can accommodate implant abutment and future restoration.
- No gender preference in selection of the patients.
Exclusion Criteria:
- Patients with systemic diseases that absolutely contraindicate dental implant placement.
- Patients with parafunctional habits (bruxism and clenching).
- Heavy smokers (i.e. More than 20 cigarettes/day)34 and alcoholism.
- Presence of local infection or lesions at the proposed area for dental implant.
- Pregnancy.
- Patient taking drugs that could affect bone healing process as immunosuppressive drugs and bisphosphonates.
- Patients with bad oral hygiene and untreated periodontal disease
- Uncooperative patients
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: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Group 1
14 immediate implants placed in the maxillary esthetic zone then placement of allograft in the gap distance around the implant.
|
after immediate implant placement the gap will be filled with allograft
|
|
Experimental: Group 2
14 immediate implants placed in the maxillary esthetic zone then placement of e-PRF in the gap distance around the implant.
|
after immediate implant placement the gap will be filled with e-PRF
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Implant stability
Time Frame: immediately ,6months follow up & one year
|
Resonance frequency analysis (RFA) values expressed as implant stability quotient (ISQ) will be recorded by (Osstell Mentor Device)
|
immediately ,6months follow up & one year
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Marginal bone loss
Time Frame: immeditely,6months follow up & one year
|
CBCT was done to assess the buccal marginal bone loss
|
immeditely,6months follow up & one year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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)
May 1, 2024
Primary Completion (Actual)
September 1, 2024
Study Completion (Actual)
September 1, 2025
Study Registration Dates
First Submitted
February 25, 2026
First Submitted That Met QC Criteria
February 25, 2026
First Posted (Actual)
March 3, 2026
Study Record Updates
Last Update Posted (Actual)
March 3, 2026
Last Update Submitted That Met QC Criteria
February 25, 2026
Last Verified
February 1, 2026
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- A0303024OS
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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