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

Alveolar Bone Resorption Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT04434703
• Other study ID #: 6-3-1
• Status: Enrolling by invitation
• Phase: N/A
• Start date: November 1, 2020
• Est. completion date: September 1, 2021

Study information

• Verified date: January 2021
• Source: Cairo University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 60
• Est. completion date: September 1, 2021
• Est. primary completion date: July 1, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Alveolar Bone Resorption
• Bone Resorption

Intervention

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
• 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
• 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

Locations

Country	Name	City	State
Egypt	School of dentistry , Cairo University	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in bucco-lingual dimensions	clinical measurement using bone caliper in mm numerical	6 months
Secondary	change in alveolar bone height	radiographic measurement using CBCT in mm numerical	6 months
Secondary	bone dentistry	radiographic measurement using CBCT	6 months
Secondary	soft tissue healing	clinical measurement using landr et al index (healing index) in numerical	6 months
Secondary	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