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

NCT04197895 | Unknown DMC

• 1 other identifier: nana2019
• Study Type: interventional
• Target: 36
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Socket Preservation

Outcome Measures

Primary Outcomes (1)

• mesial and distal height of extraction site

  digital radiograph

  2 months

Secondary Outcomes (1)

• soft tissue thickness

  2 months

Study Arms (2)

test group

EXPERIMENTAL

Socket preservation with APRF

Procedure: Socket preservation with APRF

control group

ACTIVE COMPARATOR

natural healing

Procedure: natural healing

Interventions

Socket preservation with APRF PROCEDURE

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

test group

natural healing PROCEDURE

after atraumatic extraction , the socket will be left for natural healing after suturing

control group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Nahed Gamal Saleh Abdelaal: lead

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: dentist

Study Record Dates

• First Submitted: December 11, 2019
• First Posted: December 13, 2019
• Study Start: January 1, 2020
• Primary Completion: August 10, 2020
• Study Completion: December 20, 2020
• Last Updated: December 13, 2019

Record last verified: 2019-12