- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06836570
Evalution of the Effects of PRP and LLLT on Postoperative Complications and Wound Healing After Impacted Third Molar
February 14, 2025 updated by: Serap Keskin Tunc, Yuzuncu Yıl University
Evalution of the Effects of Platelet Rich Plasma and Low Level Laser Therapy on Postoperative Complications and Wound Healing After Impacted Third Molar
The aim of the study was to compare the possible effects of platelet-rich plasma (PRP) and low-level laser (BIOLASE) on postoperative complications after extraction of impacted mandibular wisdom teeth.
60 impacted wisdom teeth of 30 healthy individuals who applied to the Department of Oral and Maxillofacial Surgery, Faculty of Dentistry, XXX University, with the indication of extraction of impacted mandibular wisdom teeth were included in the study.
60 impacted wisdom teeth of the individuals were randomly divided into two groups (A and B).
In a randomized controlled trial, platelet-rich plasma (PRP) was applied to the first group (A) (one side of the same patients) and low-level laser therapy (LLLT) was applied to the second group (B) (the other side of the same patient) immediately after surgery.
VAS (Visual analog scale) for pain assessment, facial measurements for edema assessment and maximum mouth opening for trismus assessment were compared with preoperative values.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
The aim of the study was to compare the possible effects of platelet rich plasma (PRP) and low level laser (BIOLASE) on postoperative complications after extraction of impacted lower wisdom teeth.
Sixty impacted wisdom teeth of 30 healthy individuals who applied to XXX University, Faculty of Dentistry, Department of Oral, Dental and Maxillofacial Surgery with an indication for extraction of impacted lower wisdom teeth were included in the study.
The 60 impacted wisdom teeth of the individuals were randomly divided into two groups (A and B).
In a randomised, controlled study, the first group (A) (one side of the same patients) received platelet-rich plasma (PRP) and the second group (B) (the other side of the same patient): diode laser Low-level laser therapy (LLLT) were applied immediately to the patient after surgery.
VAS (Visual analogue scale) was used for pain assessment and assessments were made at 3rd, 6th, 12th and 24th hours and at 2nd, 3rd, 4th, 5th, 6th and 7th days.
For edema assessment, preoperative facial measurements were repeated on the 2nd and 7th postoperative days and recorded.
For trismus evaluation, the maximum mouth opening measurement made preoperatively was repeated and recorded on postoperative days 2 and 7.
Study Type
Interventional
Enrollment (Actual)
30
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Van, Turkey, 60580
- Van Yüzüncü Yıl Üniversitesi Diş Hekimliği Fakültesi
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Yes
Description
Inclusion criteria;
- Individuals aged 18 and over,
- Patients with partially impacted wisdom teeth,
- Individuals with systemic status ASA0 and ASA1 according to ASA classification,
- Individuals who have not used any medication in the last two weeks,
- Individuals who do not have a lower second molar missing.
Exclusion criteria;
- Individuals with mouth opening less than 25 mm for various reasons,
- Pregnant and breastfeeding individuals,
- Individuals who do not come to postoperative check-ups,
- Individuals who use different medications other than the recommended medication.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Platalet Rich Plasma (PRP)
Platelet-rich plasma (PRP) is a preparation of autologous human platelet concentration enriched in a small amount of plasma produced by centrifuging a patient's own blood.
It is applied to the extraction socket after the extraction of an impacted wisdom tooth
|
Platelet-rich plasma (PRP) is a preparation of autologous human platelet concentration enriched in a small amount of plasma produced by centrifuging a patient's own blood.
It is applied to the extraction socket after the extraction of an impacted wisdom tooth.
|
|
Active Comparator: Low Level Laser Therapy (LLLT)
Low-level laser therapy is a technology that has been used since the mid-1960s to treat a variety of conditions requiring healing stimulation, pain and inflammation relief, and restoration of function.
A single 940 nm diode laser was applied intraorally for 120 seconds (BIOLASE) immediately after the extraction and suturing of an impacted wisdom tooth.
|
Low-level laser therapy is a technology that has been used since the mid-1960s to treat a variety of conditions requiring healing stimulation, pain and inflammation relief, and restoration of function.
A single 940 nm diode laser was applied intraorally for 120 seconds (BIOLASE) immediately after the extraction and suturing of an impacted wisdom tooth.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Visual Analog Scale (VAS)
Time Frame: 3, 6, 12 and 24 hours and the 2nd, 3rd, 4th, 5th, 6th and 7th days
|
In the pain assessment, the patients were given a VAS form at 3, 6, 12 and 24 hours and on the 2nd, 3rd, 4th, 5th, 6th and 7th days and the pain felt by the patient was marked on this scale.
This form consists of numbers between 0 and 10. 0 represents 'no pain at all' and 10 represents 'worst possible pain'.
|
3, 6, 12 and 24 hours and the 2nd, 3rd, 4th, 5th, 6th and 7th days
|
|
Trismus
Time Frame: preop, 2th and 7th days
|
In all patients participating in the study, the maximum interincisal distance for trismus was measured and recorded by the same physician before the operation and on the 2nd and 7th days after the operation.
|
preop, 2th and 7th days
|
|
Edema
Time Frame: preop, 2th and 7th days
|
For edema, some anatomical points on the face were taken as reference points and the distance between these points was measured with a tape measure and recorded.
The angulus point was determined as the center point and the distances between angulus-tragus, angulus-lateral corner of the eye, angulus-nasal base, angulus-labial commissure and angulus-pogonion point were measured.
|
preop, 2th and 7th days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
May 20, 2022
Primary Completion (Actual)
April 23, 2024
Study Completion (Actual)
May 20, 2024
Study Registration Dates
First Submitted
January 22, 2025
First Submitted That Met QC Criteria
February 14, 2025
First Posted (Actual)
March 25, 2025
Study Record Updates
Last Update Posted (Actual)
March 25, 2025
Last Update Submitted That Met QC Criteria
February 14, 2025
Last Verified
January 1, 2025
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- YYU-03/18.05.2022
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.