Alveolar Ridge Preservation Following Tooth Extraction Using Advanced Platelet Rich Fibrin (A-PRF) Versus Platelet Rich Fibrin (PRF)

NCT04434703 | Unknown DMC

• 1 other identifier: 6-3-1
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

the aim of this study is clinically and radiographically evaluate the use of advance platelet rich fibrin (A-PRF) versus platelet rich fibrin (PRF) in preservation of alveolar ridge following tooth extraction

Conditions

Alveolar Bone Resorption

Outcome Measures

Primary Outcomes (1)

• Change in bucco-lingual dimensions

  clinical measurement using bone caliper in mm numerical

  6 months

Secondary Outcomes (4)

• change in alveolar bone height

  6 months

• bone dentistry

  6 months

• soft tissue healing

  6 months

• postoperative pain scores

  2 weeks

Study Arms (3)

Platelet rich fibrin (PRF)

ACTIVE COMPARATOR

Platelet rich fibrin is the secoond generation of platelet concentrates which is an autogenous biomaterial that is prepared from the patient's own blood

Procedure: Platelet rich fibrin (PRF)

Advanced platelet rich fibrin (A-PRF)

EXPERIMENTAL

Advanced platelet rich fibrin is the last modification of PRF which is expected to contain a relatively greater number of white blood cellsand growth factors

Procedure: Advanced platelet rich fibrin (A-PRF)

blood clot

PLACEBO COMPARATOR

normal healing of the wound without adding any biomaterial

Procedure: blood clot

Interventions

Platelet rich fibrin (PRF) PROCEDURE

following atraumatic extraction of the tooth using periotomes , 10 ml of patient's blood will be drawn by vein puncture of the antecubital vein and prepared in a centrifuge at 3000 rpm for 10 minutes then criss horizontal mattress suture will be applied to close the extraction wound

Platelet rich fibrin (PRF)

Advanced platelet rich fibrin (A-PRF) PROCEDURE

following atraumatic extraction of the tooth using periotomes , 10 ml of patient's blood will be drawn by vein puncture of the antecubital vein and prepared in a centrifuge at 1300 rpm for 8 minutes then criss horizontal mattress suture will be applied to close the extraction wound

Advanced platelet rich fibrin (A-PRF)

blood clot PROCEDURE

following atraumatic extraction of the tooth using periotomes, no bio-addative will be added and criss horizontal mattress suture will be applied to close the extraction wound

blood clot

Eligibility Criteria

• Age: 20 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Patients with at least one non restorable tooth in upper inter-bicuspid region.
• Stable periodontal condition with no acute periapical infection.
• Systematically healthy conditions.
• Cooperative patients.
• Intact buccal plate of bone.

You may not qualify if:

• Smokers.
• Patients seeking immediate or early implants.
• Pregnant females.
• Bone diseases.
• Drugs and diseases that may affect platelet count or function.

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

School of dentistry , Cairo University

Cairo, 11865, Egypt

Location

MeSH Terms

Interventions

Blood Coagulation

Intervention Hierarchy (Ancestors)

Hemostasis; Blood Physiological Phenomena; Circulatory and Respiratory Physiological Phenomena

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principal investigator

Study Record Dates

• First Submitted: June 13, 2020
• First Posted: June 17, 2020
• Study Start: November 1, 2020
• Primary Completion: July 1, 2021
• Study Completion: September 1, 2021
• Last Updated: January 29, 2021

Record last verified: 2021-01

Locations

EG (1)