Effect of Albumin Platelet-Rich Fibrin or Leucocyte- Platelet-Rich Fibrin on Immediate Implant

July 30, 2025 updated by: Mostafa Fayed, Kafrelsheikh University

Clinical and Radiographic Evaluation of Xenograft With Albumin Platelet-Rich Fibrin or Leucocyte- Platelet-Rich Fibrin on Immediate Implant Placement in Mandibular Molar Extraction Sites: Randomized Clinical Trial.

The objective of this study will be to compare between Immediate Implant grafted with xenograft and Alb-PRF gel versus xenograft with L-PRF.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

The objective of this study will be to compare between xenograft with Alb-PRF gel and xenograft with L-PRF ( L-PRF Block ) in the aspects of :

  • Peri-implant vertical defect depth.
  • Crestal bone level.
  • Bucco-lingual bone width.
  • Keratinized tissue width

Study Type

Interventional

Enrollment (Estimated)

20

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 Contact

Study Locations

  • Egypt
    • Kafrelsheikh
      • Kafr Ash Shaykh, Kafrelsheikh, Egypt
        • Recruiting
        • Kafrelsheikh University, Faculty of Dentistry
        • Contact:
        • Principal Investigator:
          • Enas Ahmed Elgendy, Dean of Faculty of Dentistry

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

  1. Inclusion criteria

    • The presence of non-restorable mandibular molar.
    • Patient 18-45 years old
    • Intact buccal and lingual walls
    • Good oral hygiene.
    • Prescence of sufficient restorative space.
    • Jumping gap more than 2 mm.

  2. Exclusion criteria

    • Proximity of anatomical structures
    • Acute localized infection (suppuration at the surgical field)
    • Patients on chemotherapy or radiotherapy.
    • Patients who have systemic disorders (diseases) {diabetes mellitus, autoimmune disease, …etc},
    • Pregnant patients.
    • Smoking and Alcohols.
    • Presence of periapical pathology affecting the neighboring teeth.

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: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Albumin-PRF group
Immediate Implant Placement in lower molar region, Grafted with Xenograft and Albumin PRF Gel
Procedure: Immediate Implant Placement and Alb-PRF
Immediate Implant Placement in lower molar region, Grafted with Xenograft and Albumin PRF Gel
Experimental: L-PRF group
Immediate Implant Placement in lower molar region, Grafted with Xenograft and L-PRF ( L-PRF Block )
Procedure: Immediate Implant Placement and L-PRF
Immediate Implant Placement in lower molar region, Grafted with Xenograft and L-PRF

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Vertical peri-implant bone level
Time Frame: Immediate Post-Operative and 6 months after surgery
the distance between implant platform to the most coronal bone-implant contact
Immediate Post-Operative and 6 months after surgery
Keratinized tissue Width
Time Frame: Immediate Post-Operative and 6 months after surgery
Width of Keratinized tissue before and after surgery
Immediate Post-Operative and 6 months after surgery
Crestal bone level
Time Frame: Immediate Post-Operative and 6 months after surgery
distance between implant platform and bone crest
Immediate Post-Operative and 6 months after surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Implant Stability
Time Frame: Immediate Post-Operative and 6 months after surgery
by Smart peg
Immediate Post-Operative and 6 months after surgery
Bucco-lingual bone width
Time Frame: Immediate Post-Operative and 6 months after surgery
it's measured with a line coinciding with implant platform
Immediate Post-Operative and 6 months after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kafrelsheikh University

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 (Estimated)

August 20, 2025

Primary Completion (Estimated)

February 10, 2026

Study Completion (Estimated)

February 10, 2027

Study Registration Dates

First Submitted

February 27, 2025

First Submitted That Met QC Criteria

March 4, 2025

First Posted (Actual)

March 7, 2025

Study Record Updates

Last Update Posted (Actual)

August 1, 2025

Last Update Submitted That Met QC Criteria

July 30, 2025

Last Verified

July 1, 2025

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • KFSIRB200-531

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

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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