Clinical and Radiographic Evaluation of Advanced Platelet Rich Fibrin in the Preservation of Alveolar Ridge Following Atraumatic Tooth Extraction

Clinical and Radiographic Evaluation of Advanced Platelet Rich Fibrin in the Preservation of Alveolar Ridge Following Atraumatic Tooth Extraction: A Randomized Clinical Trial

compare the effect of application of A-PRF in socket preservation after atraumatic tooth extraction and natural healing regarding to bone remodeling . Null hypotheis, after atraumatic extraction, socket with advanced PRF has no difference with socket with blood clot in primary outcome

Study Overview

• Status: Unknown
• Conditions: Socket Preservation
• Intervention / Treatment: Procedure: Socket preservation with APRF; Procedure: natural healing

• Study Type: Interventional
• Enrollment (Anticipated): 36
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• The inclusion criteria are as follow :

  • patients with an unremarkable medical history
  • subjects with at least one site bordered by minimum of one tooth.
  • Nonsmoker
  • Teeth with root fracture, teeth with failed endodontic therapy or advanced caries
  • Intact extraction socket with no dehiscence or fenestration.
  • The buccolingual thickness of the buccal plate of bone in surgical area is 1 mm or more

Exclusion Criteria:

• Patients with systemic diseases.
• Patients with presence or history of osteonecrosis of the jaws, with use of bisphosphonates, exposure to head and neck radiation, chemotherapy.
• patients with large distinct pre-apical pathology

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: test group; Socket preservation with APRF	Procedure: Socket preservation with APRF; Socket preservation with APRF , A-PRF membranes were implanted into the extraction socket following tooth extraction. One entire A-PRF membrane would be placed at the base of the extraction socket and another A-PRF membrane will cover the extraction site then suturing will be done .Venous blood will be collected via venipuncture of the forearm with a butterfly needle into at least 10 mL sterile glass vacuum tube. The blood sample will be immediately centrifuged at 1,300 rpm (200 x g) for 8 minutes
ACTIVE_COMPARATOR: control group; natural healing	Procedure: natural healing; after atraumatic extraction , the socket will be left for natural healing after suturing

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
mesial and distal height of extraction site	digital radiograph	2 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
soft tissue thickness	will be evaluated by endo file with rubber stopper and digital caliper	2 months

Collaborators and Investigators

• Sponsor: Nahed Gamal Saleh Abdelaal

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): January 1, 2020
• Primary Completion (ANTICIPATED): August 10, 2020
• Study Completion (ANTICIPATED): December 20, 2020

Study Registration Dates

• First Submitted: December 11, 2019
• First Submitted That Met QC Criteria: December 11, 2019
• First Posted (ACTUAL): December 13, 2019

Study Record Updates

• Last Update Posted (ACTUAL): December 13, 2019
• Last Update Submitted That Met QC Criteria: December 11, 2019
• Last Verified: December 1, 2019

More Information

Terms related to this study

• Other Study ID Numbers: nana2019

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

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