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

Alveolar Ridge Preservation Following Tooth Extraction Using Advanced Platelet Rich Fibrin (A-PRF) Versus Platelet Rich Fibrin (PRF) A Randomized Clinical Trail :Comparative Study

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

Study Overview

• Status: Unknown
• Conditions: Alveolar Bone Resorption
• Intervention / Treatment: Procedure: Platelet rich fibrin (PRF); Procedure: Advanced platelet rich fibrin (A-PRF); Procedure: blood clot

Detailed Description

systemically healthy patients who have at least one non-restorable tooth in the upper inter-bicuspid region and are not seeking immediate or early implant treatment will be allocated in this study after performing nonsurgical periodontal therapy and preoperative periapical therapy to evaluate and improve the condition of the periodontal tissues.

Anesthesia will be given then flapless atraumatic extraction using periotomes followed by forceps after luxation. For all groups, the socket will be debrided using curette then

• group A, the socket will be filled with A.PRF
• group B the socket will be filled with PRF.
• group C no bio-additive will be added.
• Criss cross horizontal mattress suture will be applied to close the extraction wound.

PRF and A-PRF preparation :

10 ml of blood will be drawn from each patient by vein puncture of the antecubital vein.

• Plateletr ich fibrin (PRF) is 3000 rpm and 10 minutes without addition of anticoagulant
• Advanced platelet rich fibrin (A-PRF) is 1300 rpm and 8 minutes.

• Study Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt, 11865
    • School of dentistry , Cairo University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 60 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Platelet rich fibrin (PRF); 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); 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
Experimental: Advanced platelet rich fibrin (A-PRF); 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); 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
Placebo Comparator: blood clot; normal healing of the wound without adding any biomaterial	Procedure: blood clot; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in bucco-lingual dimensions	clinical measurement using bone caliper in mm numerical	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
change in alveolar bone height	radiographic measurement using CBCT in mm numerical	6 months
bone dentistry	radiographic measurement using CBCT	6 months
soft tissue healing	clinical measurement using landr et al index (healing index) in numerical	6 months
postoperative pain scores	clinical measurement using VAS scale in numerical where No pain (0-4 mm) - mild pain (5-44 mm) -moderate pain (45-74 mm), and severe pain (75- 100 mm).	2 weeks

Collaborators and Investigators

• Sponsor: Cairo University

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2020
• Primary Completion (Anticipated): July 1, 2021
• Study Completion (Anticipated): September 1, 2021

Study Registration Dates

• First Submitted: June 13, 2020
• First Submitted That Met QC Criteria: June 13, 2020
• First Posted (Actual): June 17, 2020

Study Record Updates

• Last Update Posted (Actual): January 29, 2021
• Last Update Submitted That Met QC Criteria: January 28, 2021
• Last Verified: January 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Bone Diseases; Bone Resorption
• Other Study ID Numbers: 6-3-1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: it will include participant's contacts ( name, age , phone number , address ,medical and dental history , periodontal condition) ,periodontal chart and preoperative radiograph

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No