Bone Substitute, Dental Implantation, Platelet-Rich Fibrin
Conditions
Keywords
Dental implant, PRF, membrane, osseointegration
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.
Detailed 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.
Interventions
BIOLOGICALPRF membrane
Placing implant with PRF membrane treatment
Sponsors
Al-Mustansiriyah University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
Yes
Inclusion 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Osseointegration | Immediately after surgery, after 12 weeks (during uncover implant surgery) | 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. |
| Bone width | Baseline (pre-surgery), immediately after the surgery, after 4 weeks, 6 weeks, 8weeks, 10 weeks, and 12 weeks. | 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) |
Countries
Iraq
Contacts
Primary ContactAssis. Prof. Dr. Afya SD Al-Radha, Ph.D
Backup ContactAssis. Prof. Dr. Afya SD Al-radha
Outcome results
None listed