Extraction, Tooth, Tooth Fracture, Tooth Crown Fracture, Root; Fracture
Conditions
Keywords
Platelet Rich Fibrin, Extraction, tooth
Brief summary
This study uses a natural material called Platelet-Rich Fibrin (PRF) to help improve healing after tooth removal. PRF is made from your own blood. A small amount of blood is taken from your arm and spun in a machine to make a thick, sticky layer full of platelets. These platelets help your body heal. PRF acts like a "natural bandage" and may help your gums and bone heal faster. Because it comes from your own body, it is safe and lowers the chance of infection or problems. The goal of this research is to see if adding PRF to a bone graft (used to fill the tooth socket after extraction) can help the area heal faster and grow more new bone. If you join this study, it will last about 4 months. You will have two teeth removed, and each socket will get a different treatment: 1. One socket (test side) will get PRF + bone graft (this combination is also called "sticky bone"). 2. The other socket (control side) will get a bone graft + a covering called a barrier membrane (made of collagen). We will compare how well the two sides heal by looking at: 1. How the gums close over the area 2. How much pain you feel 3. How much the bone changes 4. How much new bone grows You will come to the clinic for about 9 visits in total. These visits are part of your regular treatment, along with a few extra steps for the study. One possible risk is bruising or soreness from the blood draw. If we cannot collect enough blood (about 60-80 ml) because your veins are too small or hard to find, you will not continue in the study, and both sockets will be treated using the control method (bone graft + membrane).
Interventions
BIOLOGICALPlatelet-rich fibrin (PRF)
Autologous platelet concentrate prepared from the participant's blood and applied to the extraction socket, mixed with bone graft.
Human-derived bone graft material used to fill extraction sockets for ridge preservation
DEVICECollagen barrier membrane
Resorbable membrane placed over the grafted socket to stabilize the graft and prevent soft tissue ingrowth.
Sponsors
Ohio State University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Intervention model description
This is a randomized split-mouth clinical trial in which each participant receives both interventions at different intraoral sites, allowing for a within-subject comparison
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
Yes
Inclusion criteria
1. Patients of age between 18-80. 2. Non-smokers or former smokers with at least a 5-year successful cessation history. 3. Patients with normal systemic health (ASA-I) or well-controlled/stable systemic conditions (ASA-II), such as diabetes with HbA1c \< 7.0%, no recent acute myocardial infarction and cerebrovascular accidents within 6 months, or any contraindication for periodontal or implant surgery. 4. Patients treatment planned for extraction and ridge preservation for at least 2 non-adjacent single-rooted teeth.
Exclusion criteria
1. Current smokers, smokers who have quit \<5 years prior to study entry. 2. Pregnant or lactating women 3. Patients with substance or alcohol abuse 4. Patients with a history of antiresorptive therapy, head and neck radiotherapy, and chemotherapy for malignant tumors 5. Other systemic conditions or medications affecting wound healing. 6. Poor plaque control with plaque score \> 20% 7. Active/untreated odontogenic and periodontal infections
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in alveolar ridge dimensions | 4 months after ridge preservation (prior to implant placement) | Change in alveolar ridge width and height will be measured by superimposing baseline and 4-month follow-up cone-beam computed tomography (CBCT) images at standardized cross-sectional locations corresponding to the extraction sites. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Wound healing (re-epithelialization) | 1, 2, 3, and 4 weeks after ridge preservation | Soft tissue wound closure over extraction sites will be assessed using serial intraoral scans and analyzed to quantify changes in wound area over time. |
| Percentage of new bone formation | 4 months after ridge preservation (at implant placement) | Bone core biopsies obtained at implant placement will be analyzed histologically to determine the percentage of newly formed bone within the grafted sites. |
| Crestal soft tissue thickness | 4 months after ridge preservation (at implant placement) | Soft tissue thickness at the alveolar crest will be measured clinically using a periodontal probe at the time of implant placement. |
| Postoperative pain score | 1, 2, 3, and 4 weeks after ridge preservation | Participant-reported pain will be assessed using a visual analog scale (VAS, 0-100), where higher scores indicate greater pain intensity. |
Contacts
CONTACTSiraj Zabadi, DDS
CONTACTGuo-Liang Cheng, DDS, MS
Outcome results
None listed