Injectable Platelet-rich Fibrin and Advanced Platelet-rich Fibrin With Xenograft on the Socket Preservation of Mandibular Extracted Molars

April 13, 2025 updated by: Hams Hamed Abdelrahman

Comparison of the Effect of Injectable Platelet-rich Fibrin and Advanced Platelet-rich Fibrin With Xenograft on the Socket Preservation of Mandibular Extracted Molars ( a Randomised Controlled Clinical Trial) Comparison of the Effect of Injectable Platelet-rich Fibrin and Advanced Platelet-rich Fibrin With Xenograft on the Socket Preservation of Mandibular Extracted Molars ( a Randomised Controlled Clinical Trial)

Different materials and techniques are employed for socket preservation to reduce the alveolar bone resorption in both the horizontal and vertical dimensions as well as the soft tissue collapse after tooth extraction. Because of the repair abilities of the growth factors and proteins released by platelets, the development and application of platelet-enriched preparations have revolutionised the area of regenerative medicine.The present study will be designed to study the difference between A-PRF and IPRF with the addition of Xenograft in the preservation of bone in mandibular molars.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

16

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

  • Egypt
      • Alexandria, Egypt
        • Outpatient Clinic of Oral and Maxillofacial Surgery Department, Faculty of Dentistry, Alexandria 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

No

Description

Inclusion Criteria:

  • Patients who need extraction of hopeless mandibular molars
  • Teeth with advanced caries not amenable for conservative treatment
  • Patients who are willing and fully capable of complying with the study protocol.

Exclusion Criteria:

  • Systemic diseases that prevent surgery
  • Acute or chronic oral infections
  • Periodontal diseases
  • Heavy smokers or alcoholics
  • On anticoagulant drugs.
  • Pregnancy
  • History of radiotherapy or chemotherapy of the head and neck region

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: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Control
Other: Control
Control group received bone graft alone after extraction
Experimental: A-PRF
Other: A-PRF
30 mL of whole venous blood will be withdrawn from the antecubital vein via scalp vein catheter centrifuged at 1500 rpm for 14 minutes.
Experimental: I-PRF
Other: I-PRF
30 mL of whole venous blood will be withdrawn from the antecubital vein via scalp vein catheter centrifuged at 700 rpm for 3 minutes

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in healing
Time Frame: Baseline and 12 weeks
A modified Landry, Turnbull, and Howley healing index will be used to assess wound healing (HI). This entails evaluating the following parameters in a comparative manner using a dichotomic score (1/0). Tissue colour or the presence or absence of redness to indicate inflammatory processes; granulation tissue; suppuration; swelling; degree of tissue epithelialisation (partial or complete); and the presence or absence of bleeding and tenderness on palpation
Baseline and 12 weeks
change in bone density
Time Frame: Baseline and 12 weeks
Bone density will be measured using CBCT examinations
Baseline and 12 weeks

Collaborators and Investigators

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

Sponsor

Hams Hamed Abdelrahman

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)

August 22, 2023

Primary Completion (Actual)

December 17, 2024

Study Completion (Actual)

December 17, 2024

Study Registration Dates

First Submitted

April 13, 2025

First Submitted That Met QC Criteria

April 13, 2025

First Posted (Actual)

April 20, 2025

Study Record Updates

Last Update Posted (Actual)

April 20, 2025

Last Update Submitted That Met QC Criteria

April 13, 2025

Last Verified

April 1, 2025

More Information

Terms related to this study

Other Study ID Numbers

  • 0663_04/2023

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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