CClinicalTrials.gg
CompletedNCT02831374Updated Jul 13, 2016

Effectiveness of Platelet Rich Plasma in Wound Healing

An Early Phase 1 interventional study of Local anesthesia and surgical extraction of impacted third molar in Impacted Third Molar Tooth, sponsored by Linyi People's Hospital. Completed. Open to participants aged 18 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2016-07-13.

Sponsored by Linyi People's Hospital · Early Phase 1, Interventional, and Treatment

Phase
Early Phase 1
Study type
Interventional
Enrollment
40
Allocation
Randomized
Ages
18 Years to 50 Years
Sex
All
01

Study 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.

Read the detailed description

The study is designed as a prospective randomized comparative clinical study. The sample population was composed of fifty consecutive patients who needed surgical extraction of lower third molar under local anesthesia. The study included 37 male and 13 female with age ranging from 20 to 40 years. All Patients were categorized into GROUP A (wound in which PRP is placed) and GROUP B (socket without PRP). The patients were allocated randomly to each group equally by single-blind technique, irrespective of age and sex.

Ethical approval was obtained from the Institutional Ethics Committee prior to the beginning of the study. The signed consent form obtained from all the patients after explaining the risks and benefits of the surgical procedure. The group A (test group) received topical application of PRP, whereas the group B (control group) was left to heal without PRP.

Clinical assessment:

Postoperative pain was assessed using a 10-point visual analog scale (VAS) with a score of 0 equals "no pain" and 10 equals "very severe pain" 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. 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. Assessment of soft tissue healing was based on the criteria given by Landry et al. and Gonshor et al. Third molar sockets were assessed radiographically for bone healing by modification of Kelley's method as described by Olufemi et al. The percentage of facial swelling and mouth opening was estimated using the method described by Ogundipe et al.

Protocol for preparation of PRP gel Under all aseptic conditions, PRP was processed by means of a modification of the method of Sonnleitner et al. Before surgery, 10 mL of venous blood was collected from the antecubital fossa of the patient's forearm and stored into sterile tubes containing anticoagulant (0.5 mL citrate phosphate dextrose) from each patient of group A in the experimental group using routine venipuncture procedure. The tube was thoroughly agitated to ensure mixing of anticoagulant with the venous blood. The whole blood is then centrifuged at 1,200 rpm for ten minutes. The supernatant layer obtained was platelet poor plasma (PPP) and Buffy coat (BC) and RBCs (red blood cells) at the bottom part. PPP, BC and upper 1-2 mm of RBC (red blood cell) layer was collected in a new sterile tube and centrifuged again at 1,000 rpm for 10 min. The upper half of the supernatant is removed and the lower half is mixed carefully to get PRP. The platelet concentration of the PRP was noted.

PRP gel was prepared by adding Five drops of the mixture of 10 % CaCl2 and 1000 U bovine thrombin to 2mL (milliliter) PRP just before its use in extraction socket.

Surgical procedure The surgical extraction procedure was the same in all patients and carried out by the same operator. 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. Distobuccal 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. The 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 normal saline. Subsequently, PRP 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. In group B the wound is closed without application of PRP gel. Patients were advised regular post extraction and prescribed 500 mg of paracetamol postoperatively (1 tablet every 6 h for 2 days).

All patients were also advised to not consume any medications but those advised and not to get medical help somewhere else for postoperative discomfort or pain without prior information to the operator. The patients were reviewed postoperatively on 1-, 3-, 5-, 7-, and 14-day to record pain, mouth opening, Soft tissue and bony healing index. Patients were recalled at the 4th, 10th, and 16th postoperative week for assessment of bone healing.

Statistical analysis:

The data were analyzed using SPSS (Statistical Package for the Social Sciences) version 21. Descriptive statistics such as mean, SD (standard deviation ) and percentage were used. Normality of data was tested by using Kolmogorov and Smirnov method. Unpaired t-test was used to compare between groups with normally data and Mann-Whitney test for non-normally data. For categorical variables, Chi-square test was employed. A p-value less than 0.05 were considered as significant.

02

Conditions studied

  • Impacted Third Molar Tooth

Browse trials for

03

In context

Tooth, Impacted

195 studies on the registry are indexed under Tooth, Impacted; 20 are open to participants now.

This study's enrollment of 40 is below the median of 53 across 164 interventional studies indexed under Tooth, Impacted.

Browse Tooth, Impacted studies →

Lead sponsor

Linyi People's Hospital is the lead sponsor of 3 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 50 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Eligibility 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
05

Study design

Phase
Early Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
40 participants (actual)

Study arms

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

  • Placebo comparator
    surgical extraction (Group B)

    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

  • DrugLocal anesthesia

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

  • Proceduresurgical 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.

  • BiologicalPreparation 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.

  • ProcedurePlacing 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.

  • ProcedureSuturing

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

  • DrugPostoperative medication

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

06

What researchers measure

Primary outcomes

  1. 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"

    Time frame: 1 week

  2. 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.

    Time frame: 1 week

  3. 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.

    Time frame: 1 week

  4. Assessment of soft tissue healing

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

    Time frame: 1 week

  5. 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.

    Time frame: 1 week

07

Study locations

No study locations are listed for this record.

08

References and documents

Publications

  • 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. PubMed 25729230 ↗
  • 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. PubMed 32712962 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 13, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02831374
Lead sponsor
Linyi People's Hospital
Responsible party
Xiao-Ming Shi (Dr, Linyi People's Hospital) — Principal investigator
First posted
Jul 13, 2016
Start date
Oct 2015
Primary completion
Mar 2016
Completion
Mar 2016
Last update
Jul 13, 2016

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2016. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion