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Impacted Third Molar ToothEarly Phase 1NCT02831374

Effectiveness of Platelet Rich Plasma in Wound Healing

A Early Phase 1 study testing Local anesthesia, surgical extraction of impacted third molar and Preparation of PRP gel in people with Impacted Third Molar Tooth, run by Linyi People's Hospital.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 50 yearsHealthy volunteers can take part
Conditions the study is for
Impacted Third Molar Tooth
What is being tested?
Local anesthesia, surgical extraction of impacted third molar and Preparation of PRP gel
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
40 participants
Where
No sites listed yet
Study dates
Oct 2015to Mar 2016
Phase
Early Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 50 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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.

Who cannot join

  • 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

About this study

Official title: Assessment Effectiveness of Platelet Rich Plasma in Wound Healing After Surgical Removal of Mandibular Third Molars: A Clinical Study

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.

Being tested
Local anesthesia, surgical extraction of impacted third molar, Preparation of PRP gel, Placing platelet Rich plasma and suturing, Suturing

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Local anesthesiaDrug

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

  • surgical extraction of impacted third molarProcedure or surgery

    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.

  • Preparation of PRP gelBiological

    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.

  • Placing platelet Rich plasma and suturingProcedure or surgery

    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.

  • SuturingProcedure or surgery

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

  • Postoperative medicationDrug

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

Study groups in NCT02831374
Study groupRoleWhat they receive
Use of platelet rich plasma (Group A)'ExperimentalLocal anesthesia, surgical extraction of impacted third molar, Preparation of PRP gel, Placing platelet Rich plasma and suturing, Postoperative medication
Receives: 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 comparatorLocal anesthesia, surgical extraction of impacted third molar, Suturing, Postoperative medication
Receives: Drug: Local anesthesia; Procedure: surgical extraction of impacted third molar; Procedure: Suturing; Drug: Postoperative medication

What is being measured

The primary outcome is the main question the study is designed to answer.

  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"

    Measured: 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.

    Measured: 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.

    Measured: 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.

    Measured: 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.

    Measured: 1 week

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Jul 2016 (estimated)
  2. Study startOct 2015
  3. Primary completionMar 2016
  4. Study completionMar 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Early Phase 1
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
40 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02831374
Sponsor's protocol ID
LinyiPH
Status last verified
Jul 2016
First submitted
23 Jun 2016
Last updated
13 Jul 2016
Results posted
No
Data monitoring committee
No
Individual data sharing
No

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

Questions about this trial

What is this clinical trial studying?

A Early Phase 1 study testing Local anesthesia, surgical extraction of impacted third molar and Preparation of PRP gel in people with Impacted Third Molar Tooth, run by Linyi People's Hospital.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 13 Jul 2016. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Assessment of pain (time frame: 1 week). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02831374, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jul 2016.

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