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

NCT06936358 | Completed

• 1 other identifier: 0663_04/2023
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Tooth Extraction; Socket Preservation

Outcome Measures

Primary Outcomes (2)

• Change in healing

  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

  Bone density will be measured using CBCT examinations

  Baseline and 12 weeks

Study Arms (3)

Control

ACTIVE COMPARATOR

Other: Control

A-PRF

EXPERIMENTAL

Other: A-PRF

I-PRF

EXPERIMENTAL

Other: I-PRF

Interventions

Control OTHER

Control group received bone graft alone after extraction

Control

A-PRF OTHER

30 mL of whole venous blood will be withdrawn from the antecubital vein via scalp vein catheter centrifuged at 1500 rpm for 14 minutes.

A-PRF

I-PRF OTHER

30 mL of whole venous blood will be withdrawn from the antecubital vein via scalp vein catheter centrifuged at 700 rpm for 3 minutes

I-PRF

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Hams Hamed Abdelrahman: lead

Study Sites (1)

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

Alexandria, Egypt

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Lecturer of Dental Public Health and biostatistical consultanat

Study Record Dates

• First Submitted: April 13, 2025
• First Posted: April 20, 2025
• Study Start: August 22, 2023
• Primary Completion: December 17, 2024
• Study Completion: December 17, 2024
• Last Updated: April 20, 2025

Record last verified: 2025-04

Locations

EG (1)