Impacted Third Molar ToothNCT06836570
Evalution of the Effects of PRP and LLLT on Postoperative Complications and Wound Healing After Impacted Third Molar
A study testing Platalet Rich Plasma and Low Level Laser Therapy in people with Impacted Third Molar Tooth, run by Yuzuncu Yil University at 1 site in Turkey (Türkiye).
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Impacted Third Molar Tooth
- What is being tested?
- Platalet Rich Plasma and Low Level Laser Therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 20 May 2022to 20 May 2024
- Phase
- Interventional
- 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 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Van Yüzüncü Yıl Üniversitesi Diş Hekimliği Fakültesi
Van, 60580
About this study
Official title: 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.
Read the 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.
- Conditions
- Impacted Third Molar Tooth
- Being tested
- Platalet Rich Plasma, Low Level Laser Therapy
- Keywords
- Platalet rich plasma, Low level laser, impacted third molar
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Platalet Rich PlasmaBiological
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.
Low Level Laser TherapyOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Platalet Rich Plasma (PRP) | Active comparator | 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 Receives: Biological: Platalet Rich Plasma |
| Low Level Laser Therapy (LLLT) | Active comparator | 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. Receives: Other: Low Level Laser Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analog Scale (VAS)
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'.
Measured: 3, 6, 12 and 24 hours and the 2nd, 3rd, 4th, 5th, 6th and 7th days
Trismus
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.
Measured: preop, 2th and 7th days
Edema
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.
Measured: preop, 2th and 7th days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2025
- Study start20 May 2022
- Primary completion23 Apr 2024
- Study completion20 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Impacted Third Molar ToothStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yuzuncu Yil University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Serap Keskin Tunc, Yuzuncu Yil University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06836570
- Sponsor's protocol ID
- YYU-03/18.05.2022
- Status last verified
- Jan 2025
- First submitted
- 22 Jan 2025
- Last updated
- 20 Feb 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evalution of the Effects of Platelet Rich Plasma and Low Level Laser Therapy on Postoperative Complications and Wound Healing After Impacted Third Molar
- ClinicalTrials.gov ID
- NCT06836570
- Acronym / sponsor ID
- YYU-03/18.05.2022
- Conditions
- Impacted Third Molar Tooth
- Keywords
- Platalet rich plasma, Low level laser, impacted third molar
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Yuzuncu Yil UniversityUniversity, hospital or other
- Study start
- 20 May 2022 (actual)
- Primary completion
- 23 Apr 2024 (actual)
- Study completion
- 20 May 2024 (actual)
- First posted
- 20 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Platalet Rich Plasma (PRP) | Active comparator | Biological: Platalet Rich PlasmaPlatelet-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 |
| Low Level Laser Therapy (LLLT) | Active comparator | Other: Low Level Laser TherapyLow-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. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Platalet Rich PlasmaPlatelet-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. | Biological | Platalet Rich Plasma (PRP) |
| Low Level Laser TherapyLow-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. | Other | Low Level Laser Therapy (LLLT) |
Primary outcome
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'.
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Platalet Rich Plasma and Low Level Laser Therapy in people with Impacted Third Molar Tooth, run by Yuzuncu Yil University at 1 site in Turkey (Türkiye).
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 5 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 20 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
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?
Visual Analog Scale (VAS) (time frame: 3, 6, 12 and 24 hours and the 2nd, 3rd, 4th, 5th, 6th and 7th days). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 20 Feb 2025.