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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT05427643
Other study ID # 964_07706223546
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date December 15, 2021
Est. completion date May 2023

Study information

Verified date June 2022
Source University of Baghdad
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 13
Est. completion date May 2023
Est. primary completion date March 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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. - 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. -

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
study group
dental implant procedure under local anesthesia
control group
dental implant procedure under local anesthesia

Locations

Country Name City State
Iraq college of dentistry university of Baghdad Baghdad

Sponsors (1)

Lead Sponsor Collaborator
Sora Salam Majeed

Country where clinical trial is conducted

Iraq, 

Outcome

Type Measure Description Time frame Safety issue
Primary secondary implant stability measured by Anycheck device after osseointegration time six months
See also
  Status Clinical Trial Phase
Completed NCT03854162 - A Study of a Surgical Guide for Dental Implantology N/A