- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07324213
Healing of Mandibular Third Molar Extraction Sockets Using Platelet Concentrates and Photobiomodulation
Evaluation of the Degree of Regeneration of Post-Extraction Alveolar Sockets of Mandibular Third Molars Using Tissue Engineering and Photobiomodulation
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.
Study Overview
Status
Conditions
Detailed Description
Surgical extraction of impacted mandibular third molars frequently results in postoperative complications such as pain, edema, trismus, and delayed bone regeneration. Advances in regenerative medicine have introduced autologous platelet concentrates, including advanced platelet-rich fibrin (A-PRF+) and concentrated growth factors (CGF), which provide sustained release of growth factors that may enhance soft and hard tissue healing. Additionally, photobiomodulation using low-level laser therapy has been reported to reduce inflammation and stimulate tissue regeneration.
This single-center, randomized, single-blind clinical trial was conducted to evaluate the effectiveness of A-PRF+, CGF, and photobiomodulation, applied alone or in combination, in enhancing postoperative healing following mandibular third molar extraction.
A total of 122 generally healthy adult participants requiring surgical extraction of a partially or fully impacted mandibular third molar were enrolled. Participants were randomly allocated to one of six parallel study groups: standard extraction with primary wound closure (control), extraction with photobiomodulation, extraction with socket augmentation using A-PRF+, extraction with socket augmentation using CGF, extraction with A-PRF+ combined with photobiomodulation, or extraction with CGF combined with photobiomodulation. All surgical procedures were performed under standardized clinical conditions. Primary wound closure was attempted in all cases. Photobiomodulation was performed using a diode laser with a wavelength of 635 nm, power output of 100 mW, and energy density of 4 J/cm², applied at four points around the extraction socket. Autologous platelet concentrates were prepared from the patient's peripheral blood using standardized centrifugation protocols.
Clinical outcomes, including postoperative pain assessed using a visual analogue scale, facial swelling, mouth opening, and early wound healing, were evaluated at 1, 3, and 7 days after surgery. Radiological assessment of bone regeneration within the extraction socket was performed 3 to 4 months postoperatively using cone-beam computed tomography-based fractal dimension analysis.
The study was conducted in accordance with the Declaration of Helsinki and Good Clinical Practice guidelines. All participants provided written informed consent prior to enrollment. The findings of this study aim to contribute to the optimization of postoperative management following mandibular third molar extraction by identifying effective regenerative treatment strategies.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Wroclaw, Poland
- Medyczne Centrum Innowacji Wrocław Sp. z o.o.
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Other: Control - Standard Extraction
Participants underwent surgical extraction of an impacted mandibular third molar followed by standard primary wound closure without the use of platelet concentrates or photobiomodulation.
|
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.
|
|
Other: Photobiomodulation
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.
|
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.
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.
|
|
Other: A-PRF+
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.
|
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.
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.
Other Names:
|
|
Other: CGF
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.
|
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.
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.
Other Names:
|
|
Other: A-PRF+ Plus Photobiomodulation
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.
|
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.
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.
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.
Other Names:
|
|
Other: CGF Plus Photobiomodulation
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.
|
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.
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.
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.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Alveolar Bone Regeneration
Time Frame: 4 months after surgery
|
Bone regeneration within the post-extraction socket assessed using cone-beam computed tomography-based fractal dimension analysis.
|
4 months after surgery
|
|
Postoperative Pain Intensity
Time Frame: 1 day, 3 days, and 7 days after surgery
|
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
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Postoperative Swelling
Time Frame: 1 day, 3 days, and 7 days after surgery
|
Facial swelling assessed using standardized clinical measurements.
|
1 day, 3 days, and 7 days after surgery
|
|
Postoperative Trismus
Time Frame: 1 day, 3 days, and 7 days after surgery
|
Maximum mouth opening assessed by measuring interincisal distance.
|
1 day, 3 days, and 7 days after surgery
|
|
Early Wound Healing
Time Frame: 7 days after surgery
|
Early soft tissue healing was evaluated using the Early Healing Index (EHI), an ordinal scale with scores ranging from 1 (very poor soft tissue healing) to 5 (excellent soft tissue healing), with higher scores indicating a more favorable healing outcome.
|
7 days after surgery
|
Collaborators and Investigators
Collaborators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- KB7052019-UMW
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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.
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