Clinical trial NCT06964178: The Effect of Photodynamic Therapy on Post-extraction Third Molar
Official title: The Effect of Antimicrobial Photodynamic Therapy on the Healing of the Post-extraction Socket of the Mandibular Third Molar: a Randomized Clinical Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Photodynamic Therapy
Third Molar Extraction
Antimicrobial Photodynamic Therapy
Keywords: Photodynamic Therapy
third molar extraction
Soft tissue
Lead sponsor: Universita di Verona
Sponsor class: OTHER
First posted: 2025-05-09
Enrollment: 60
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Probing Pocket Depth PPD Index
timeFrame: T0 (Baseline), T1(14 days after extraction) and T2 (3 month after extraction)
Secondary outcomes:
measure: Recession REC Index
timeFrame: T0 (Baseline), T1(14 days after extraction) and T2 (3 month after extraction)
measure: Clinical attachment level CAL Index
timeFrame: T0 (Baseline), T1(14 days after extraction) and T2 (3 month after extraction)
measure: Plaque Index
timeFrame: T0 (Baseline), T1(14 days after extraction) and T2 (3 month after extraction)
measure: Bleeding on probing BOP Index
timeFrame: T0 (Baseline), T1(14 days after extraction) and T2 (3 month after extraction)
measure: Landry's healing index
timeFrame: T0 (Baseline), T1(14 days after extraction) and T2 (3 month after extraction)
measure: Bone density Index
timeFrame: T0 (Baseline), T1(14 days after extraction) and T2 (3 month after extraction)
Other outcomes:
Locations:
city: Verona
country: Italy
facility: Alessia Pardo
Study officials:
References:
citation: Schulz KF, Altman DG, Moher D; CONSORT Group. CONSORT 2010 statement: updated guidelines for reporting parallel group randomized trials. Ann Intern Med. 2010 Jun 1;152(11):726-32. doi: 10.7326/0003-4819-152-11-201006010-00232. Epub 2010 Mar 24.
citation: Yamada SI, Hasegawa T, Yoshimura N, Hakoyama Y, Nitta T, Hirahara N, Miyamoto H, Yoshimura H, Ueda N, Yamamura Y, Okuyama H, Takizawa A, Nakanishi Y, Iwata E, Akita D, Itoh R, Kubo K, Kondo S, Hata H, Koyama Y, Miyamoto Y, Nakahara H, Akashi M, Kirita T, Shibuya Y, Umeda M, Kurita H. Prevalence of and risk factors for postoperative complications after lower third molar extraction: A multicenter prospective observational study in Japan. Medicine (Baltimore). 2022 Aug 12;101(32):e29989. doi: 10.1097/MD.0000000000029989.
citation: Fraga RS, Antunes LAA, Fialho WLS, Valente MI, Gomes CC, Fontes KBFC, Antunes LS. Do Antimicrobial Photodynamic Therapy and Low-Level Laser Therapy Minimize Postoperative Pain and Edema After Molar Extraction? J Oral Maxillofac Surg. 2020 Dec;78(12):2155.e1-2155.e10. doi: 10.1016/j.joms.2020.08.002. Epub 2020 Aug 7.
citation: Souza MRJ, Meyfarth S, Fraga RS, Fontes KBFC, Guimaraes LS, Antunes LAA, Antunes LS. Do Antimicrobial Photodynamic Therapy and Low-Level Laser Therapy Influence Oral Health-Related Quality of Life After Molar Extraction? J Oral Maxillofac Surg. 2023 Aug;81(8):1033-1041. doi: 10.1016/j.joms.2023.04.002. Epub 2023 Apr 13.
citation: Schar D, Ramseier CA, Eick S, Arweiler NB, Sculean A, Salvi GE. Anti-infective therapy of peri-implantitis with adjunctive local drug delivery or photodynamic therapy: six-month outcomes of a prospective randomized clinical trial. Clin Oral Implants Res. 2013 Jan;24(1):104-10. doi: 10.1111/j.1600-0501.2012.02494.x. Epub 2012 May 9.
citation: Fisher SE, Frame JW, Rout PG, McEntegart DJ. Factors affecting the onset and severity of pain following the surgical removal of unilateral impacted mandibular third molar teeth. Br Dent J. 1988 Jun 11;164(11):351-4. doi: 10.1038/sj.bdj.4806453. No abstract available.