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Influence of Human Platelet Derivatives on Dental Implant

A

Al-Mustansiriyah University

Status

Not yet enrolling

Conditions

Bone Substitute
Platelet-Rich Fibrin
Dental Implantation

Treatments

Biological: PRF membrane

Study type

Interventional

Funder types

Other

Identifiers

NCT06044246
MUOSU-202103

Details and patient eligibility

About

The goal of this randomized controlled trial is to evaluate the benefit of PRF membrane on bone around dental implant in patients who need treatment with dental implant.

Aims of the study:

  • To study the effect of PRF membrane (with or without bone substitute on increasing bone dimension around dental implant.
  • To investigate the effects of compositions of PRF (platelets count, WBC count) on bone healing.

Full description

Materials and methods:

PRF will be obtained from a blood sample that is taken from the patient at the time of surgery in 10-mL tubes, the blood-containing tube is placed in a centrifuge at specially controlled rotations, temperature and time. The result is the separation of blood, basically from two by-products, including PRF. The PRF clot will be placed in specific box ( P.R.F -System; Surgident, CE ) to create a PRF membrane with specific thickness that will be placed on the bone around dental implant.

Evaluation of the results

  • Alveolar bone width around dental implant will be measured.
  • Histological examination of the tissue that excised during dental implant uncover surgery.
  • Evaluate pain by visual analogue score (VAS).
  • Estimate the count of WBC and platelets in whole blood will be obtained from a laboratory results.

Enrollment

30 estimated patients

Sex

All

Ages

20+ years old

Volunteers

Accepts Healthy Volunteers

Inclusion and exclusion criteria

IInclusion criteria

  • Non- smoker.
  • No medical history of any systemic diseases that affect the bone metabolism.
  • Did not receive any systemic drugs.
  • Has edentulous area that needs dental implant.

The exclusion criteria were as follows:

  • Systemic disease or medication compromising bone and soft tissue healing.
  • Pathology in the edentulous region.
  • Bruxism.
  • Disease of the oral mucosa.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

30 participants in 2 patient groups

experimental group
Experimental group
Description:
Placing dental implant with PRF membrane treatment alone or combined with bone substitute.
Treatment:
Biological: PRF membrane
control group
No Intervention group
Description:
Placing dental implant

Trial documents
1

Trial contacts and locations

1

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Central trial contact

Assis. Prof. Dr. Afya SD Al-Radha, Ph.D; Assis. Prof. Dr. Afya SD Al-radha

Data sourced from clinicaltrials.gov

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