Evaluation of the Effect of Injectable Platelet Rich Fibrin on Stability of Dental Implant for Narrow Ridges

Evaluation of Secondary Dental Implant Stability Utilized For Narrow Ridges With Injectable Platelet Rich Fibrin Versus Straightforward Cases

the main aim of the study is to evaluate the secondary implant stability when using dental implants with injectable platelet rich fibrin accompanied by non-autogenous bone graft material in narrow ridge cases versus straightforward ridges , in clinical comparative study.

Study Overview

• Status: Active, not recruiting
• Conditions: Dental Implantation, Endosseous
• Intervention / Treatment: Procedure: study group; Procedure: control group

Detailed Description

the main aim of the study is to evaluate the secondary implant stability when using dental implants with injectable platelet rich fibrin accompanied by non-autogenous bone graft material in narrow ridge cases versus straightforward ridges , in clinical comparative study.

Study design:

Forty implants will be installed for this prospective clinical study, the implants will be equally divided into two groups.

Group A (control group) in which the implants will be installed in a straightforward cases.

Group B (study group) in which the implants will be installed by utilizing injectable PRF with non-autogenous bone graft material in narrow ridges.

Preparation of Injectable Platelet Rich Fibrin for the narrow ridge cases is as following:

Five ML of autologous blood to be collected from the forearm (median cubital vein \ cephalic vein \ basilic vein ) by needle gauge with a 5mL sterile syringe without anticoagulant. The entire blood is moved to a 5 milliliter plastic tube, directly centrifugated for 3 minutes at 700 rpm/min at room temperature. A liquid form ( Injectable PRF ) is then achieved on top of the tube just and the red corpuscles at the bottom. Subsequently, the Injectable PRF liquid form is collected from the tube by a sterile plastic syringe, Then it will be mixed with non-autogenous bone graft waiting for 4min, and applied in the area with narrow ridge( deficiency in the horizontal bone width ) .

Follow up Twenty four weeks after surgery , The uncoverage surgery is done under L.A using a tissue paunch for installing the healing abutment ( gingival former ) , Then the secondary stability of implant (Osseointegration) is to be measured using the (Anycheck ) device , and comparing the 2 groups

• Study Type: Interventional
• Enrollment (Anticipated): 13
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Iraq
  • Baghdad, Iraq
    • college of dentistry university of Baghdad

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Patients ≥ 18 years of age.
2. Absence of general medical contraindications for oral surgery procedures such as (Radiated jaws / uncontrolled Diabetic patient / uncontrolled hypertensive patient ).
3. Straightforward cases / narrow ridges (less than 6mm horizontal bone width) according to SAC classification ( advanced surgery ) cases.
4. Patients with reasonable oral hygiene.

5. Partially or totally edentulous alveolar ridges.

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Exclusion Criteria:

1. Uncontrolled medically compromised patients such as : (heart diseases uncontrolled blood pressure, endocrine disorders such as (diabetes , Thyroid disorders , osteoporosis ) , immuno-compromised patient and any condition influence bone healing ……etc.
2. Heavy smokers ( ≥ 20 cigarettes a day).
3. Patients with parafunctional habits.
4. Complicated cases according to SAC classification.

5. Patient with signs of acute infection and purulent exudates at the site of implant placement as revealed by clinical and radiographical examination.

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Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: study group; patients need dental implants with narrow alveolar ridge of less than 6 mm horizontal width . they will receive dental implants with I_PRF mixed with synthetic bone graft.	Procedure: study group; dental implant procedure under local anesthesia; Other Names: I-PRF preparation
Experimental: control group; patients need dental implant with adequate horizontal bone with of more than 6 mm.	Procedure: control group; dental implant procedure under local anesthesia

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
secondary implant stability	measured by Anycheck device after osseointegration time	six months

Collaborators and Investigators

• Sponsor: Sora Salam Majeed

Publications and helpful links

Helpful Links

• The application of injectable platelet-rich fibrin in regenerative dentistry: A systematic scoping review of In vitro and In vivo studies

Study record dates

Study Major Dates

• Study Start (Actual): December 15, 2021
• Primary Completion (Anticipated): March 1, 2023
• Study Completion (Anticipated): May 1, 2023

Study Registration Dates

• First Submitted: June 17, 2022
• First Submitted That Met QC Criteria: June 17, 2022
• First Posted (Actual): June 22, 2022

Study Record Updates

• Last Update Posted (Actual): June 29, 2022
• Last Update Submitted That Met QC Criteria: June 24, 2022
• Last Verified: June 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: 964_07706223546

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

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