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Clinical Trials/NCT05427643
NCT05427643
Unknown
Not Applicable

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

Sora Salam Majeed1 site in 1 country13 target enrollmentDecember 15, 2021

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Dental Implantation, Endosseous
Sponsor
Sora Salam Majeed
Enrollment
13
Locations
1
Primary Endpoint
secondary implant stability
Last Updated
3 years ago

Overview

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.

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

Registry
clinicaltrials.gov
Start Date
December 15, 2021
End Date
May 2023
Last Updated
3 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Sponsor
Sora Salam Majeed
Responsible Party
Sponsor Investigator
Principal Investigator

Sora Salam Majeed

Principle investigator

University of Baghdad

Eligibility Criteria

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.

Outcomes

Primary Outcomes

secondary implant stability

Time Frame: six months

measured by Anycheck device after osseointegration time

Study Sites (1)

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