Influence of Human Platelet Derivatives on Dental Implant

NCT06044246 | Not Yet Recruiting

• 1 other identifier: MUOSU-202103
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Platelet-Rich Fibrin; Dental Implantation; Bone Substitute

Keywords

Dental implant; PRF; membrane; osseointegration

Outcome Measures

Primary Outcomes (2)

• 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)

• 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.

Study Arms (2)

experimental group

EXPERIMENTAL

Placing dental implant with PRF membrane treatment alone or combined with bone substitute.

Biological: PRF membrane

control group

NO INTERVENTION

Placing dental implant

Interventions

PRF membrane BIOLOGICAL

Placing implant with PRF membrane treatment

experimental group

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Al-Mustansiriyah University: lead

Study Sites (1)

Kadhimiya Teaching HospitalKadhimiya Educational Hospital

Baghdad, Alkadhmiya City, 60 St, Iraq

Location

Study Officials

• Assis. Prof. Dr. Afya SD Al-radha

  College of Dentistry, Mustansiriyah University.

  PRINCIPAL INVESTIGATOR

Central Study Contacts

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

CONTACT

07816883387; drafya_diab@uomustansiriyah.edu.iq

Assis. Prof. Dr. Afya SD Al-radha

CONTACT

07816883387; drafya_diab@yahoo.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: November 24, 2022
• First Posted: September 21, 2023
• Study Start: June 20, 2024
• Primary Completion: May 30, 2025
• Study Completion: July 30, 2025
• Last Updated: March 19, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: following publication. No end date.
• Access Criteria: Anyone who wishes to access the data.

Locations

IR (1)