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Status unknownNCT05427643Updated Jun 29, 2022

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

An interventional study of study group and control group in Dental Implantation, Endosseous, sponsored by Sora Salam Majeed. Status unknown at 1 site in Iraq. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-06-29.

Sponsored by Sora Salam Majeed · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Jun 2022), so the status shown — last known as Active, not recruiting — may be out of date.

From the registry’s dates

  • Registered 6 months after the study started (first participant enrolled Dec 2021, registered Jun 2022).
Phase
Not applicable
Study type
Interventional
Enrollment
13
Allocation
Non-randomized
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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

02

Conditions studied

  • Dental Implantation, Endosseous
03

In context

Lead sponsor

This is the only study on the registry with Sora Salam Majeed as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

-

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.

    -

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
13 participants (estimated)

Study arms

  • 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

  • Experimental
    control group

    patients need dental implant with adequate horizontal bone with of more than 6 mm.

    Procedure: control group

Interventions

  • Procedurestudy group

    dental implant procedure under local anesthesia

    Also known as: I-PRF preparation

  • Procedurecontrol group

    dental implant procedure under local anesthesia

06

What researchers measure

Primary outcomes

  1. secondary implant stability

    measured by Anycheck device after osseointegration time

    Time frame: six months

07

Study locations

1 site
  • college of dentistry university of Baghdad
    Baghdad, Iraq
08

References and documents

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 29, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05427643
Lead sponsor
Sora Salam Majeed
Responsible party
Sora Salam Majeed (Principle investigator, University of Baghdad) — Sponsor-investigator
First posted
Jun 22, 2022
Start date
Dec 15, 2021
Primary completion
Mar 2023 (estimated)
Completion
May 2023 (estimated)
Last update
Jun 29, 2022

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jun 2022. You cannot join it, but the record below documents what was studied.

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