Influence of Human Platelet Derivatives on Dental Implant

Dental Implantation Clinical Trial

Official title:

Influence of Human Platelet Derivatives on Dental Implant Osseointegration

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06044246
• Other study ID #: MUOSU-202103
• Status: Not yet recruiting
• Phase: N/A
• Start date: June 20, 2024
• Est. completion date: July 30, 2025

Study information

• Verified date: March 2024
• Source: Al-Mustansiriyah University
• Contact: Assis. Prof. Dr. Afya SD Al-Radha, Ph.D
• Phone: 07816883387
• Email: drafya_diab[@]uomustansiriyah.edu.iq
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 30
• Est. completion date: July 30, 2025
• Est. primary completion date: May 30, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Bone Substitute
• Dental Implantation
• Platelet-Rich Fibrin

Intervention

Biological:
• PRF membrane
Placing implant with PRF membrane treatment

Locations

Country	Name	City	State
Iraq	Kadhimiya Teaching HospitalKadhimiya Educational Hospital	Baghdad	Alkadhmiya City

Sponsors (1)

Lead Sponsor	Collaborator
Al-Mustansiriyah University

Country where clinical trial is conducted

Iraq, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Osseointegration	Evaluation of the changes in the degree of osseointegration will be performed using Osstell devise. [Osstell ISQ device. (Stampgatan, Gteborg, Sweden)] The Unit of measurement: ISQ (Implant Stability Quotient), which is a scale from 1 to 100.	Immediately after surgery, after 12 weeks (during uncover implant surgery)
Primary	Bone width	Measure the dimensional changes using special caliper (vernier) measurement tool, to evaluate the changes of bone width around dental implant. the Unit of measurement: millimeter (mm) (Bone and mucosa)	Baseline (pre-surgery), immediately after the surgery, after 4 weeks, 6 weeks, 8weeks, 10 weeks, and 12 weeks.