NCT06836570

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2022

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 20, 2022

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 23, 2024

Completed
27 days until next milestone

Study Completion

Last participant's last visit for all outcomes

May 20, 2024

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

January 22, 2025

Completed
29 days until next milestone

First Posted

Study publicly available on registry

February 20, 2025

Completed
Last Updated

February 20, 2025

Status Verified

January 1, 2025

Enrollment Period

1.9 years

First QC Date

January 22, 2025

Last Update Submit

February 14, 2025

Conditions

Keywords

Platalet rich plasmaLow level laserimpacted third molar

Outcome Measures

Primary Outcomes (3)

  • 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'.

    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.

    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.

    preop, 2th and 7th days

Study Arms (2)

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

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.

Other: Low Level Laser Therapy

Interventions

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.

Platalet Rich Plasma (PRP)

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 (LLLT)

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Van Yüzüncü Yıl Üniversitesi Diş Hekimliği Fakültesi

Van, 60580, Turkey (Türkiye)

Location

MeSH Terms

Interventions

Low-Level Light Therapy

Intervention Hierarchy (Ancestors)

Laser TherapyTherapeuticsPhototherapy

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

January 22, 2025

First Posted

February 20, 2025

Study Start

May 20, 2022

Primary Completion

April 23, 2024

Study Completion

May 20, 2024

Last Updated

February 20, 2025

Record last verified: 2025-01

Locations