Impact of Biological Factors on Dental Implant

NCT06037070 | Not Yet Recruiting

• 1 other identifier: MUOSU-202104
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this randomized controlled trial is to compare the response of different bone densities to treatment with Platelet Rich Fibrin (PRF) in patients who need treatment with dental implant. The main questions it aims to answer are:

• To investigate if bone reaction to PRF differ with different bone densities.
• To study the effect of PRF on dental implant healing and to assess its effectiveness in accelerating osseointegration. Participants who need treatment with dental implant will be planned to include in this study and will be asked if they are willing to participate in this study voluntarily. All the participants will be given an information sheet and a consent form which provides simple description about the present study and its importance to insure voluntary participation. The patients will be aware that they are completely free to withdraw from the research any time during the research time. Platelet Rich Fibrin will be injected inside the hole that prepared to place dental implant in. Bone density will be evaluated, degree of osseointegration will be monitored.

Conditions

Dental Implant

Keywords

Dental implants; PRF; CBCT; osseointegration; bone density

Outcome Measures

Primary Outcomes (2)

• osseointegration

  Evaluation of the changes in the degree of osseointegration will be performed using Osstell devise.

  Immediately after surgery, after two weeks, 4 weeks, 6 weeks, 8weeks, 10 weeks, and 12 weeks

• Bone density

  Determined using CBCT

  before surgery, with the treatment plan preparation

Study Arms (2)

group with PRF

EXPERIMENTAL

PRF placed inside the hole that prepared to place dental implant

Biological: Platelet Rich Fibrin

control group

NO INTERVENTION

with out and additive

Interventions

Platelet Rich Fibrin BIOLOGICAL

PRF will be injected inside the hole that prepared to place dental implant

group with PRF

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 at least two successive implants.

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

• Afya SD Al-radha, Ph. D

  College of Dentistry / Mustansiriyah University, P.O. Box: 14022,Baghdad, Iraq

  PRINCIPAL INVESTIGATOR

Central Study Contacts

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

CONTACT

07816883387; drafya_diab@uomustansiriyah.edu.iq

Afya SD Al-radha, Ph.D

CONTACT

07816883387; drafya_diab@uomustansiriyah.edu.iq

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

Model Details: Split-mouth trials

Study Record Dates

• First Submitted: November 22, 2022
• First Posted: September 14, 2023
• Study Start: May 10, 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: after publication of the research, No end date.
• Access Criteria: Anyone who wishes to access the data.

Locations

IR (1)