Effectiveness of Platelet Rich Plasma in Wound Healing

NCT02831374 | Completed Early Phase 1

• 1 other identifier: LinyiPH
• Study Type: interventional
• Target: 40
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Impacted Third Molar Tooth

Outcome Measures

Primary Outcomes (5)

• Assessment of pain

  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"

  1 week

• Assessment of facial swelling

  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.

  1 week

• Assessment of trismus

  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.

  1 week

• Assessment of soft tissue healing

  Assessment of soft tissue healing was based on the criteria given by Landry et al. and Gonshor.

  1 week

• Assessment of bone healing

  Third molar sockets were assessed radiographically for bone healing by modification of the Kelley's method as described by Olufemi et al.

  1 week

Study Arms (2)

Use of platelet rich plasma (Group A)'

EXPERIMENTAL

Local anesthesia, surgical extraction of impacted third molar, Preparation of PRP gel, Placing platelet Rich plasma and suturing, Postoperative medication

Drug: Local anesthesia; Procedure: surgical extraction of impacted third molar; Biological: Preparation of PRP gel; Procedure: Placing platelet Rich plasma and suturing; Drug: Postoperative medication

surgical extraction (Group B)

PLACEBO COMPARATOR

Local anesthesia, surgical extraction of impacted third molar, Suturing, Postoperative medication

Drug: Local anesthesia; Procedure: surgical extraction of impacted third molar; Procedure: Suturing; Drug: Postoperative medication

Interventions

Local anesthesia DRUG

The surgical extraction under local anesthesia (2% Lignocaine and 1:100000 Adrenaline) procedure was the same in all patients.

Use of platelet rich plasma (Group A)'; surgical extraction (Group B)

surgical extraction of impacted third molar PROCEDURE

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.

Use of platelet rich plasma (Group A)'; surgical extraction (Group B)

Preparation of PRP gel BIOLOGICAL

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.

Use of platelet rich plasma (Group A)'

Placing platelet Rich plasma and suturing PROCEDURE

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.

Use of platelet rich plasma (Group A)'

Suturing PROCEDURE

Wound closure was done using simple interrupted 3.0 black silk sutures.

surgical extraction (Group B)

Postoperative medication DRUG

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

Use of platelet rich plasma (Group A)'; surgical extraction (Group B)

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Linyi People's Hospital: lead

Related Publications (2)

• Gawai KT, Sobhana CR. Clinical evaluation of use of platelet rich plasma in bone healing. J Maxillofac Oral Surg. 2015 Mar;14(1):67-80. doi: 10.1007/s12663-013-0605-5. Epub 2014 Jan 9.

  PMID: 25729230 BACKGROUND

• Bailey E, Kashbour W, Shah N, Worthington HV, Renton TF, Coulthard P. Surgical techniques for the removal of mandibular wisdom teeth. Cochrane Database Syst Rev. 2020 Jul 26;7(7):CD004345. doi: 10.1002/14651858.CD004345.pub3.

  PMID: 32712962 DERIVED

MeSH Terms

Interventions

Anesthesia, Local; Sutures

Intervention Hierarchy (Ancestors)

Anesthesia, Conduction; Anesthesia; Anesthesia and Analgesia; Surgical Fixation Devices; Surgical Equipment; Equipment and Supplies

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr

Study Record Dates

• First Submitted: June 23, 2016
• First Posted: July 13, 2016
• Study Start: October 1, 2015
• Primary Completion: March 1, 2016
• Study Completion: March 1, 2016
• Last Updated: July 13, 2016

Record last verified: 2016-07

Data Sharing

• IPD Sharing: Will not share