Impact of Biological Factors on Dental Implant

Dental Implant Clinical Trial

Official title:

Impact of Biological Factors on Dental Implant Osseointegration

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06037070
• Other study ID #: MUOSU-202104
• Status: Not yet recruiting
• Phase: N/A
• Start date: May 10, 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 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.

Description:

Materials and methods:

Two implants will be implanted at the same time, one will have PRF that will be injected inside the hole that prepared to place dental implant in [PRF is obtained from a blood sample 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 other implant will not receive any treatment (the control one).

Evaluation of the results

• Evaluation of bone density in implant site will be determined using CBCT [ the same CBCT that have been used for planning dental implant treatment].

***[In dental implant treatment it is mandatory to perform CBCT for each patient, to ensure the accuracy of dental implant size and position, and to ensure there will be no damage to any vital structure during surgery (e.g. inferior dental nerve, maxillary sinus, …etc)].

• Evaluation of the degree of osseointegration will be performed using Osstell devise. [Osstell is a tool uses Resonance Frequency Analysis (RFA) that measures the frequency with which a device vibrates]. Measurement will be conducted at implant placement for a baseline reading and after 2weeks, 4weeks, 8 weeks, 10 weeks, 12 weeks.

• Evaluate pain by visual analogue score (VAS).

• Estimate of the complete blood picture, vit D, Ca and K will obtained from laboratory results.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 10
• 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

Inclusion 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 at least two successive implants.

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

• Dental Implant

Intervention

Biological:
• Platelet Rich Fibrin
PRF will be injected inside the hole that prepared to place dental implant

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.	Immediately after surgery, after two weeks, 4 weeks, 6 weeks, 8weeks, 10 weeks, and 12 weeks
Primary	Bone density	Determined using CBCT	before surgery, with the treatment plan preparation