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

Sponsor

Sora Salam Majeed (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT05427643

Collaborator

(none)

Enrollment

Location

Arms

16.5

Anticipated Duration (Months)

0.8

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Dental Implantation, Endosseous	Procedure: study group Procedure: control group	N/A

Detailed Description

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 Design

Study Type:

Interventional

Anticipated Enrollment :

13 participants

Allocation:

Non-Randomized

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Dec 15, 2021

Anticipated Primary Completion Date :

Mar 1, 2023

Anticipated Study Completion Date :

May 1, 2023

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

secondary implant stability [six months]
measured by Anycheck device after osseointegration time

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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

Exclusion Criteria:

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.
Heavy smokers ( ≥ 20 cigarettes a day).
Patients with parafunctional habits.
Complicated cases according to SAC classification.
Patient with signs of acute infection and purulent exudates at the site of implant placement as revealed by clinical and radiographical examination.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	college of dentistry university of Baghdad	Baghdad		Iraq

Sponsors and Collaborators

Sora Salam Majeed

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

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

Publications

None provided.

Responsible Party:

Sora Salam Majeed, Principle investigator, University of Baghdad

ClinicalTrials.gov Identifier:

NCT05427643

Other Study ID Numbers:

964_07706223546

First Posted:

Jun 22, 2022

Last Update Posted:

Jun 29, 2022

Last Verified:

Jun 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Study Results

No Results Posted as of Jun 29, 2022