NCT07324213

Brief Summary

Surgical removal of impacted mandibular third molars is a common procedure that may be associated with postoperative pain, swelling, limited mouth opening, and delayed bone healing. Various regenerative techniques are used to improve healing outcomes after tooth extraction. This study evaluated whether autologous platelet concentrates (advanced platelet-rich fibrin \[A-PRF+\] and concentrated growth factors \[CGF\]) and photobiomodulation using low-level laser therapy can improve healing after mandibular third molar extraction. Participants requiring surgical removal of a mandibular third molar were randomly assigned to one of six treatment groups. Depending on the group, patients received standard wound closure alone, photobiomodulation, placement of autologous platelet concentrates into the extraction socket, or a combination of platelet concentrates and photobiomodulation. Postoperative pain, swelling, mouth opening, and early wound healing were assessed during the first postoperative week. Bone regeneration within the extraction socket was evaluated using radiological imaging several months after surgery. All procedures used in this study are commonly applied in clinical practice and are considered safe. The results of this study may help identify the most effective approach to improve healing and reduce postoperative discomfort following mandibular third molar extraction.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
122

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2020

Longer than P75 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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 2, 2020

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 20, 2023

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 20, 2024

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

December 23, 2025

Completed
15 days until next milestone

First Posted

Study publicly available on registry

January 7, 2026

Completed
Last Updated

January 21, 2026

Status Verified

December 1, 2025

Enrollment Period

4 years

First QC Date

December 23, 2025

Last Update Submit

January 16, 2026

Conditions

Keywords

Mandibular third molar extraction,Platelet-rich fibrin,Concentrated growth factors,Fractal dimension analysisLow-level laser therapy,Photobiomodulation,Bone regeneration,

Outcome Measures

Primary Outcomes (2)

  • Postoperative Pain Intensity

    Postoperative pain intensity was assessed using a visual analogue scale (VAS) ranging from 1 to 10, where 1 indicates no pain and 10 indicates the worst pain imaginable.

    1 day, 3 days, and 7 days after surgery

  • Alveolar Bone Regeneration

    Bone regeneration within the post-extraction socket assessed using cone-beam computed tomography-based fractal dimension analysis.

    4 months after surgery

Secondary Outcomes (3)

  • Postoperative Swelling

    1 day, 3 days, and 7 days after surgery

  • Postoperative Trismus

    1 day, 3 days, and 7 days after surgery

  • Early Wound Healing

    7 days after surgery

Study Arms (6)

Control - Standard Extraction

OTHER

Participants underwent surgical extraction of an impacted mandibular third molar followed by standard primary wound closure without the use of platelet concentrates or photobiomodulation.

Procedure: Mandibular Third Molar Extraction With Primary Wound Closure

Photobiomodulation

OTHER

Participants underwent surgical extraction of an impacted mandibular third molar followed by primary wound closure and photobiomodulation using low-level laser therapy applied immediately after surgery and during follow-up visits.

Procedure: Mandibular Third Molar Extraction With Primary Wound ClosureOther: Photobiomodulation

A-PRF+

OTHER

Participants underwent surgical extraction of an impacted mandibular third molar followed by placement of autologous advanced platelet-rich fibrin (A-PRF+) into the extraction socket prior to primary wound closure.

Procedure: Mandibular Third Molar Extraction With Primary Wound ClosureBiological: Autologous Platelet Concentrates

CGF

OTHER

Participants underwent surgical extraction of an impacted mandibular third molar followed by placement of autologous concentrated growth factors (CGF) into the extraction socket prior to primary wound closure.

Procedure: Mandibular Third Molar Extraction With Primary Wound ClosureBiological: Autologous Platelet Concentrates

A-PRF+ Plus Photobiomodulation

OTHER

Participants underwent surgical extraction of an impacted mandibular third molar followed by placement of autologous advanced platelet-rich fibrin (A-PRF+) into the extraction socket and adjunctive photobiomodulation using low-level laser therapy.

Procedure: Mandibular Third Molar Extraction With Primary Wound ClosureBiological: Autologous Platelet ConcentratesOther: Photobiomodulation

CGF Plus Photobiomodulation

OTHER

Participants underwent surgical extraction of an impacted mandibular third molar followed by placement of autologous concentrated growth factors (CGF) into the extraction socket and adjunctive photobiomodulation using low-level laser therapy.

Procedure: Mandibular Third Molar Extraction With Primary Wound ClosureBiological: Autologous Platelet ConcentratesOther: Photobiomodulation

Interventions

Surgical extraction of a partially or fully impacted mandibular third molar performed under standardized clinical conditions, followed by primary wound closure with sutures. This procedure was applied in all study arms.

A-PRF+A-PRF+ Plus PhotobiomodulationCGFCGF Plus PhotobiomodulationControl - Standard ExtractionPhotobiomodulation

Autologous platelet concentrates prepared from the participant's peripheral blood and placed into the extraction socket prior to primary wound closure. Advanced platelet-rich fibrin (A-PRF+) and concentrated growth factors (CGF) were obtained using standardized centrifugation protocols and used according to the allocated study arm.

Also known as: Advanced Platelet-Rich Fibrin (A-PRF+), Concentrated Growth Factors (CGF)
A-PRF+A-PRF+ Plus PhotobiomodulationCGFCGF Plus Photobiomodulation

Adjunctive photobiomodulation performed using low-level laser therapy applied to the extraction site. The intervention was delivered immediately after surgery and during follow-up visits according to the study protocol.

A-PRF+ Plus PhotobiomodulationCGF Plus PhotobiomodulationPhotobiomodulation

Eligibility Criteria

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

You may qualify if:

  • Adults aged 18 to 40 years.
  • Indication for surgical extraction of a partially or fully impacted mandibular third molar.
  • Generally healthy individuals without systemic diseases.
  • Ability to provide written informed consent.
  • Willingness to attend scheduled follow-up visits.

You may not qualify if:

  • Presence of systemic diseases or metabolic disorders.
  • Pregnancy or breastfeeding.
  • Smoking.
  • Recent antibiotic therapy.
  • Poor oral hygiene.
  • Exceptionally difficult tooth position.
  • Surgical procedure exceeding the expected duration.
  • Inability to achieve primary wound closure.
  • Failure to comply with follow-up visits.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Medyczne Centrum Innowacji Wrocław Sp. z o.o.

Wroclaw, Poland

Location

MeSH Terms

Conditions

Alveolar Bone Loss

Interventions

Low-Level Light Therapy

Condition Hierarchy (Ancestors)

Bone ResorptionBone DiseasesMusculoskeletal DiseasesPeriodontal AtrophyPeriodontal DiseasesMouth DiseasesStomatognathic Diseases

Intervention Hierarchy (Ancestors)

Laser TherapyTherapeuticsPhototherapy

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
Participants were not informed about the type of regenerative intervention applied. Due to the nature of the surgical procedures, care providers and investigators were not masked.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Participants were randomly assigned to one of six parallel intervention groups and received only the intervention allocated to their study arm.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor, PhD, DSc (Med.), Specialist in Oral Surgery

Study Record Dates

First Submitted

December 23, 2025

First Posted

January 7, 2026

Study Start

January 2, 2020

Primary Completion

December 20, 2023

Study Completion

December 20, 2024

Last Updated

January 21, 2026

Record last verified: 2025-12

Data Sharing

IPD Sharing
Will not share

Individual participant data will not be shared due to institutional data protection policies and the need to protect participant privacy. Aggregated and anonymized results are reported in publications arising from this study.

Locations