The Effect of Photodynamic Therapy on Post-extraction Third Molar

NCT06964178 | Completed DMC

• 1 other identifier: Univr4242
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Photodynamic Therapy; Third Molar Extraction; Antimicrobial Photodynamic Therapy

Keywords

Photodynamic Therapy; third molar extraction; Soft tissue

Outcome Measures

Primary Outcomes (1)

• Probing Pocket Depth PPD Index

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

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

Secondary Outcomes (6)

• Recession REC Index

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

• Clinical attachment level CAL Index

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

• Plaque Index

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

• Bleeding on probing BOP Index

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

• Landry's healing index

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

Study Arms (2)

antimicrobial photodynamic therapy (aPDT) after extraction of third molar

EXPERIMENTAL

extraction, the need for osteotomy, odontotomy, and root separation was recorded. The test group received antimicrobial photodynamic therapy (aPDT) immediately before suturing. A diode laser with a wavelength of 660 nm was used (Helbo® TheraLite Laser, Bredent, Germany). a wavelength of 660 nm was used (Helbo® TheraLite Laser, Bredent, Germany). A strip of gauze was soaked with Helbo® Biofilm Marker and the socket was swabbed. This liquid is based on phenothiazine chloride and was provided in pre-packaged sterile syringes. Photosensitizer was left in the post-extraction socket for three minutes. All alveolar walls were irradiated for ten seconds each (disto-lingual, lingual, mesio-lingual, mesio-buccal, buccal, disto-buccal), for a total duration of 60 seconds.

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

extraction of third molar

NO INTERVENTION

A trapezoidal flap was elevated, and the tooth was extracted. During the extraction, the need for the post-extraction socket was sutured with Vicryl 4.0 sutures. In the control group, once the tooth was removed, the post-extraction site was cleaned by curettage, washed with saline, and then sutured with Vicryl 4.0 suture. The duration of the surgery was recorded, as well as the degree of intraoperative bleeding., odontotomy, and root separation was recorded.

Interventions

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

Also known as: antimicrobial photodynamic therapy (aPDT) after extraction of third molar

antimicrobial photodynamic therapy (aPDT) after extraction of third molar

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Universita di Verona: lead

Study Sites (1)

Alessia Pardo

Verona, Italy, 37134, Italy

Location

Related Publications (6)

• 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.

  PMID: 20335313 BACKGROUND

• 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.

  PMID: 35960058 BACKGROUND

• 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.

  PMID: 32890472 BACKGROUND

• 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.

  PMID: 37094757 BACKGROUND

• 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.

  PMID: 22568744 BACKGROUND

• 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.

  PMID: 3165011 BACKGROUND

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: PhD, Dental Hygienist

Study Record Dates

• First Submitted: April 23, 2025
• First Posted: May 9, 2025
• Study Start: November 3, 2023
• Primary Completion: May 30, 2024
• Study Completion: May 30, 2024
• Last Updated: May 9, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)