Photodynamic TherapyNCT06964178
The Effect of Photodynamic Therapy on Post-extraction Third Molar
A study testing Experimental: antimicrobial photodynamic therapy (aPDT) after extraction of third molar in people with Photodynamic Therapy and Third Molar Extraction, run by Universita di Verona at 1 site in Italy.
Trial 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… Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Photodynamic Therapy, Third Molar Extraction, Antimicrobial Photodynamic Therapy
- What is being tested?
- Experimental: antimicrobial photodynamic therapy (aPDT) after extraction of third molar
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteItaly
- Study dates
- 3 Nov 2023to 30 May 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Being tested
- Experimental: antimicrobial photodynamic therapy (aPDT) after extraction of third molar
- Keywords
- Photodynamic Therapy, third molar extraction, Soft tissue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Experimental: antimicrobial photodynamic therapy (aPDT) after extraction of third molarDevice
Also called 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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Probing Pocket Depth PPD Index
Probing depth is the distance from the gingival margin to the base of the pocket (mm)
Measured: T0 (Baseline), T1(14 days after extraction) and T2 (3 month after extraction)
Secondary outcomes (6)
Recession REC Index
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)
Measured: T0 (Baseline), T1(14 days after extraction) and T2 (3 month after extraction)
Clinical attachment level CAL Index
measured in mm as distance from the CEJ to the gingival margin (GM)
Measured: T0 (Baseline), T1(14 days after extraction) and T2 (3 month after extraction)
Plaque Index
This index ascertains the thickness of plaque along the gingival margin (%)
Measured: T0 (Baseline), T1(14 days after extraction) and T2 (3 month after extraction)
Bleeding on probing BOP Index
is an indicator of tissue inflammatory response to bacterial pathogens (%)
Measured: T0 (Baseline), T1(14 days after extraction) and T2 (3 month after extraction)
Landry's healing index
(code 1 (very poor healing); • code 2 (poor healing); • code 3 (good healing) ; • code 4 (very good healing); • code 5 (excellent healing)
Measured: T0 (Baseline), T1(14 days after extraction) and T2 (3 month after extraction)
Bone density Index
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..
Measured: T0 (Baseline), T1(14 days after extraction) and T2 (3 month after extraction)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2025
- Study start3 Nov 2023
- Primary completion30 May 2024
- Study completion30 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Photodynamic TherapyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universita di Verona
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alessia Pardo, Universita di Verona
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06964178
- Sponsor's protocol ID
- Univr4242
- Status last verified
- Apr 2025
- First submitted
- 23 Apr 2025
- Last updated
- 9 May 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 20335313Yamada 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.
PubMed 35960058Fraga 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.
PubMed 32890472Souza 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.
PubMed 37094757Schar 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.
PubMed 22568744Fisher 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.
PubMed 3165011
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06964178
- Acronym / sponsor ID
- Univr4242
- Keywords
- Photodynamic Therapy, third molar extraction, Soft tissue
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Universita di VeronaUniversity, hospital or other
- Study start
- 3 Nov 2023 (actual)
- Primary completion
- 30 May 2024 (actual)
- Study completion
- 30 May 2024 (actual)
- First posted
- 9 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| antimicrobial photodynamic therapy (aPDT) after extraction of third molar | Experimental | Device: Experimental: antimicrobial photodynamic therapy (aPDT) after extraction of third molarextraction, 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. |
| 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Experimental: antimicrobial photodynamic therapy (aPDT) after extraction of third molarAlso: antimicrobial photodynamic therapy (aPDT) after extraction of third molarIn 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 | Device | antimicrobial photodynamic therapy (aPDT) after extraction of third molar |
Primary outcome
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)
6 secondary outcomes
Recession REC Index
Time frame: T0 (Baseline), T1(14 days after extraction) and T2 (3 month after extraction)
Clinical attachment level CAL Index
Time frame: T0 (Baseline), T1(14 days after extraction) and T2 (3 month after extraction)
Plaque Index
Time frame: T0 (Baseline), T1(14 days after extraction) and T2 (3 month after extraction)
Bleeding on probing BOP Index
Time frame: T0 (Baseline), T1(14 days after extraction) and T2 (3 month after extraction)
Landry's healing index
Time frame: T0 (Baseline), T1(14 days after extraction) and T2 (3 month after extraction)
Bone density Index
Time frame: T0 (Baseline), T1(14 days after extraction) and T2 (3 month after extraction)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 May 2025.
- Background: PubMed 20335313Schulz 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.
- Background: PubMed 35960058Yamada 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.
- Background: PubMed 32890472Fraga 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.
- Background: PubMed 37094757Souza 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.
- Background: PubMed 22568744Schar 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.
- Background: PubMed 3165011Fisher 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Experimental: antimicrobial photodynamic therapy (aPDT) after extraction of third molar in people with Photodynamic Therapy and Third Molar Extraction, run by Universita di Verona at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Probing Pocket Depth PPD Index (time frame: T0 (Baseline), T1(14 days after extraction) and T2 (3 month after extraction)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06964178, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 May 2025.