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Completed

NCT Number: NCT06964178

The Effect of Photodynamic Therapy on Post-extraction Third Molar

The extraction of lower third molars is one of the most frequent procedures in oral surgery. For this reason, the extraction of these teeth generally requires a surgical approach involving the elevation of a mucoperiosteal flap and osteotomy to allow the use of elevators and removal of tooth in pieces or as a whole depending on the situation. As a result, it is a more invasive procedure than simple dental extraction, which leads a more challenging healing period for the patient, with complications such as pain, swelling, and trismus. Literature studies suggest that the peak of pain reported by patients occurs 3-5 hours after the local anesthetic wears off, while swelling reaches its maximum in the first 24-48 hours before gradually decreasing. In the first hours following the surgery, in addition to symptom onset, reparative mechanisms begin, contributing to the healing of the post-extraction site. Independent of the use of bone grafts, antimicrobial photodynamic therapy (aPDT) has been introduced to enhance healing and for disinfection of the extraction site5,6. aPDT uses a non-thermal photochemical reaction which promotes the excitation of a nontoxic dye (photosensitizer) by light at an appropriate wavelength. This causes an interaction with molecular oxygen and acts by damaging biomolecules selectively and destroying bacterial membranes7. The efficacy of this therapy in reducing bacterial load has been demonstrated in literature, and it has been widely used in patients with periodontitis or peri-implantitis since several years8. Although the primary use of antimicrobial photodynamic therapy seems to be related to periodontal and peri-implant diseases, its use in oral surgery to disinfect the socket and reduce the risk of complications related to bacterial contamination of the surgical site should not be underestimated9. Furthermore, the biostimulator effect of the laser can promote tissue healing after surgery through vasodilation, activation of microcirculation, and enhancement of tissue metabolism, thus reducing the recovery time for the patient10. There are still a few papers in literature that evaluate the effect of aPDT on post-operative healing after wisdom tooth extractions. This study aimed to investigate the effect of aPDT on the healing of soft and hard tissues and on post-surgical discomfort in subjects undergoing mandibular third molar extraction. The null hypothesis is that aPDT has no beneficial effects compared to spontaneous healing.

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Key information

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Alessia Pardo

Verona, Italy, 37134

About this study

Patients in need of unilateral mandibular third molar extraction were randomly assigned to test or control group before surgery. In the test, a photoactive substance activated with laser light (20 mW, 660 nm) was applied to the post-extraction site for 60 seconds before suturing, to promote healing and disinfection. The control group did not receive any laser applications after tooth removal.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Healthy patients (ASA I/II according to the American Society of Anesthesiologists classification),
  • Requiring at least one mandibular third molar extraction without preoperative significant pain or edema
  • Patients aged between 14-39 years.

Exclusion criteria

  • Patients with systemic diseases interfering with normal healing process
  • Pregnant or lactating women
  • Patients with third molar buds
  • Patients with continuity between the roots of the lower third molar
  • The cortical bone of the mandibular nerve canal were excluded from the study

Treatment and study plan

Experimental: antimicrobial photodynamic therapy (aPDT) after extraction of third molar

Device

In the test, a photoactive substance activated with laser light (20 mW, 660 nm) was applied to the post-extraction site for 60 seconds before suturing, to promote healing and disinfection

Other names: antimicrobial photodynamic therapy (aPDT) after extraction of third molar

Primary outcomes

  1. Probing Pocket Depth PPD Index

    Time frame: T0 (Baseline), T1(14 days after extraction) and T2 (3 month after extraction)

    Probing depth is the distance from the gingival margin to the base of the pocket (mm)

Secondary outcomes

  1. Recession REC Index

    Time frame: T0 (Baseline), T1(14 days after extraction) and T2 (3 month after extraction)

    Recession is the apical shift of the marginal tissues associated with the attachment loss exposing the root or implant surface to the oral environment (mm)

  2. Clinical attachment level CAL Index

    Time frame: T0 (Baseline), T1(14 days after extraction) and T2 (3 month after extraction)

    measured in mm as distance from the CEJ to the gingival margin (GM)

  3. Plaque Index

    Time frame: T0 (Baseline), T1(14 days after extraction) and T2 (3 month after extraction)

    This index ascertains the thickness of plaque along the gingival margin (%)

  4. Bleeding on probing BOP Index

    Time frame: T0 (Baseline), T1(14 days after extraction) and T2 (3 month after extraction)

    is an indicator of tissue inflammatory response to bacterial pathogens (%)

  5. Landry's healing index

    Time frame: T0 (Baseline), T1(14 days after extraction) and T2 (3 month after extraction)

    (code 1 (very poor healing); • code 2 (poor healing); • code 3 (good healing) ; • code 4 (very good healing); • code 5 (excellent healing)

  6. Bone density Index

    Time frame: T0 (Baseline), T1(14 days after extraction) and T2 (3 month after extraction)

    bone density through intraoral radiographs was also assessed through peri-apical x-rays at T2, attributing a value from 0 to 2. A value of 0 corresponded to a low degree of bone density, with radiolucency in correspondence with the extracted dental element and marked radiopacity; a value of 1 corresponded to a medium density with slight radiopacity at the extracted third molar, compatible with the apposition of new immature bone and persistence of marked radiopacity; a value of 2 corresponded to a high bone density with radiopacity in correspondence with the extracted element, compatible with new bone apposition..

Sponsors and collaborators

Lead sponsor

Universita di Verona

Other

Registry information

Official study title

The Effect of Antimicrobial Photodynamic Therapy on the Healing of the Post-extraction Socket of the Mandibular Third Molar: a Randomized Clinical Study

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
May 9, 2025
Registry last updated
May 9, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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