Effectiveness of Platelet Rich Plasma in Wound Healing
NCT02831374 · Status: COMPLETED · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 40
Last updated 2016-07-13
Summary
Purpose: This prospective randomized comparative clinical study was conducted to assess the effect of platelet-rich plasma (PRP) gel on soft tissue healing and bone regeneration potential on lower third molar extraction sockets.
Methods: For the study, 50 Patients (37 male, 13 female) requiring surgical removal of a lower impacted third molar and who fulfilled the inclusion criteria were recruited. The patients were categorized into two groups, Group A and Group B. For each group 25 patients were randomly allocated. The predictor variable in Group A was the application of PRP Gel whereas in Group B had no PRP. Postoperative pain, swelling, trismus, soft tissue healing and osseous regeneration was assessed using standard methods. These outcome variables were assessed on 1, 3-, 5-, 7-, and 14-postoperative day. Patients were recalled at the 4th, 10th, and 16th postoperative week for assessment of bone healing. The data were recorded and tabulated.
Conditions
- Impacted Third Molar Tooth
Interventions
- DRUG
-
Local anesthesia
The surgical extraction under local anesthesia (2% Lignocaine and 1:100000 Adrenaline) procedure was the same in all patients.
- PROCEDURE
-
surgical extraction of impacted third molar
After achieving Local anesthesia using 2% lignocaine hydrochloride with 1:100,000 epinephrine, standard Terrence Ward's incision was placed to raise a full thickness mucoperiosteal flap. Disto-buccal bone was carefully exposed and bone surrounding the buccal aspect of impacted tooth was performed using surgical bur under copious irrigation with 0.9% saline. Tooth was elevated using Coupland elevator and if required situations tooth was sectioned with surgical bur to facilitate its removal. The socket was checked for any tooth or bony debris. The bony margins smoothened using a file and irrigated with 0.9% saline.
- BIOLOGICAL
-
Preparation of PRP gel
Before surgery, 10 milliliter of venous blood was collected from the anticubital fossa of the patients forearm and stored into sterile tubes containing anticoagulant (0.5 milliliter citrate phosphate dextrose) from each patient in the experimental group using routine venipuncture procedure. The whole blood is then centrifuged at 1,200 rotations per minute for ten minutes. The supernatant layer obtained was platelet poor plasma and buffy coat was collected in a new sterile tube and centrifuged again at 1,000 rotations per minute for 10 min. The upper half of the supernatant is removed and the lower half is mixed carefully to get platelet rich plasma. Five drops of mixture of 10 % CaCl2 and 1000 Units bovine thrombin to 2 milliliter Platelet rich plasma to obtain the gel form.
- PROCEDURE
-
Placing platelet Rich plasma and suturing
Subsequently, platelet rich plasma gel was placed into the extraction sockets of patients in the group A and wound closure was done using simple interrupted 3.0 black silk sutures.
- PROCEDURE
-
Suturing
Wound closure was done using simple interrupted 3.0 black silk sutures.
- DRUG
-
Postoperative medication
Patients were advised regular post extraction and prescribed 500 milligram of paracetemol postoperatively (1 tablet every 6 hours for 2 days).
Sponsors & Collaborators
-
Linyi People's Hospital
lead OTHER
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 50 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2015-10-31
- Primary Completion
- 2016-03-31
- Completion
- 2016-03-31
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