The Effect of Photodynamic Therapy on Post-extraction Third Molar

NCT ID: NCT06964178

Last Updated: 2025-05-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-11-03

Study Completion Date

2024-05-30

Brief Summary

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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

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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.

Conditions

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Photodynamic Therapy Third Molar Extraction Antimicrobial Photodynamic Therapy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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antimicrobial photodynamic therapy (aPDT) after extraction of third molar

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.

Group Type EXPERIMENTAL

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

Intervention Type 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

extraction of third molar

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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

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

Intervention Type DEVICE

Other Intervention Names

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antimicrobial photodynamic therapy (aPDT) after extraction of third molar

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Universita di Verona

OTHER

Sponsor Role lead

Responsible Party

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Alessia Pardo

PhD, Dental Hygienist

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Alessia Pardo

Verona, Italy, Italy

Site Status

Countries

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Italy

References

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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.

Reference Type BACKGROUND
PMID: 20335313 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 35960058 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 32890472 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 37094757 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 22568744 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 3165011 (View on PubMed)

Other Identifiers

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Univr4242

Identifier Type: -

Identifier Source: org_study_id

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