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Effectiveness of Platelet Rich Plasma in Wound Healing

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ClinicalTrials.gov Identifier: NCT02831374
Recruitment Status : Completed
First Posted : July 13, 2016
Last Update Posted : July 13, 2016
Sponsor:
Information provided by (Responsible Party):
Xiao-Ming Shi, Linyi People's Hospital

Brief 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.


Condition or disease Intervention/treatment Phase
Impacted Third Molar Tooth Drug: Local anesthesia Procedure: surgical extraction of impacted third molar Biological: Preparation of PRP gel Procedure: Placing platelet Rich plasma and suturing Procedure: Suturing Drug: Postoperative medication Early Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Assessment Effectiveness of Platelet Rich Plasma in Wound Healing After Surgical Removal of Mandibular Third Molars: A Clinical Study
Study Start Date : October 2015
Actual Primary Completion Date : March 2016
Actual Study Completion Date : March 2016

Arm Intervention/treatment
Experimental: Use of platelet rich plasma (Group A)'
Local anesthesia, surgical extraction of impacted third molar, Preparation of PRP gel, Placing platelet Rich plasma and suturing, Postoperative medication
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.

Drug: Postoperative medication
Patients were advised regular post extraction and prescribed 500 milligram of paracetemol postoperatively (1 tablet every 6 hours for 2 days).

Placebo Comparator: surgical extraction (Group B)
Local anesthesia, surgical extraction of impacted third molar, Suturing, Postoperative medication
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.

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).




Primary Outcome Measures :
  1. Assessment of pain [ Time Frame: 1 week ]
    Postoperative pain was assessed using a 10-point visual analog scale with a score of 0 equals "no pain" and 10 equals "very severe pain"

  2. Assessment of facial swelling [ Time Frame: 1 week ]
    Facial swelling was assessed by modification of Schultze-Mosgau et al. method, and this involved measuring the length from the tragus to the oral commissure and tragus to the pogonion. The arithmetic sum of the two measurements was considered as facial swelling at the time point.

  3. Assessment of trismus [ Time Frame: 1 week ]
    The maximum distance between the maxillary central incisors and the mandibular central incisors was taken as mouth opening. The difference between postoperative and preoperative mouth opening value was considered as trismus.

  4. Assessment of soft tissue healing [ Time Frame: 1 week ]
    Assessment of soft tissue healing was based on the criteria given by Landry et al. and Gonshor.

  5. Assessment of bone healing [ Time Frame: 1 week ]
    Third molar sockets were assessed radiographically for bone healing by modification of the Kelley's method as described by Olufemi et al.



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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Patients age between 18 and 50 years.
  • Patients who required mandibular 3rd molar extractions
  • Patients had to have clinical and radiographic diagnosis of a single impacted mandibular third molar
  • Radiographic diagnosis of Class II position B impaction (Pell and Gregory classification).
  • Patients agree to return for recall visits
  • Patients who were not experienced pain, inflammation, and infection at the operating site 7 days before the surgery.

Exclusion Criteria:

Exclusion criterion

  • Patients if pregnant, lactating, or smokers or if they had systemic disease or any other medications that could interfere with healing process.
  • Any antibiotic or any anti-inflammatory drug usage within a week period.
  • Patients with any periapical infection or lesion associated with the third molars
  • Patients with unacceptable oral hygiene
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Xiao-Ming Shi, Dr, Linyi People's Hospital
ClinicalTrials.gov Identifier: NCT02831374    
Other Study ID Numbers: LinyiPH
First Posted: July 13, 2016    Key Record Dates
Last Update Posted: July 13, 2016
Last Verified: July 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Tooth, Impacted
Tooth Diseases
Stomatognathic Diseases
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs