Efficacy of Adjunctive At-Home Photodynamic Therapy (aPDT) in the Treatment of Peri-Implant Mucositis

NCT06859866 | Recruiting

• 1 other identifier: PhoPIM
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

The study aims to establish a validated protocol enabling an alternative approach for bacterial biofilm control through the application of a novel at-home photodynamic/antibacterial blue light therapy in addition to non-surgical professional treatment (NST) for peri-implant mucositis. The primary outcomes will include reductions in plaque and bleeding scores, decreases in probing pocket depth, and lower aMMP-8 levels in PISF. Secondary outcomes will include changes in keratinized peri-implant mucosa (KPIM) and patient-reported outcome measures (PROMs).

Conditions

Peri-implant Mucositis

Keywords

APDT; aMMP-8; antibacterial

Outcome Measures

Primary Outcomes (2)

• Bleeding on probing (BOP)

  Change in the inflammatory parameter BOP.A full-mouth assessment at six sites per tooth (mesiobuccal, buccal, distobuccal, mesiolingual, lingual, distolingual). Gingival bleeding is considered as positive if bleeding occurs within 15 seconds after gentle probing with a probe at the sulcus. Dichotomous scoring to each site of the tooth as bleeding "1 present" and "0 absent". BOP is reported as the percentage (%) of sites with positive findings. Calculation formula: number of bleeding sites/ 6 times number of teeth.

  12 months

• Bleeding on probing (BOP)

  Change in the inflammatory parameter BOP.A full-mouth assessment at six sites per tooth (mesiobuccal, buccal, distobuccal, mesiolingual, lingual, distolingual). Gingival bleeding is considered as positive if bleeding occurs within 15 seconds after gentle probing with a probe at the sulcus. Dichotomous scoring to each site of the tooth as bleeding "1 present" and "0 absent". BOP is reported as the percentage (%) of sites with positive findings. Calculation formula: number of bleeding sites/ 6 times number of teeth.

  6 months

Secondary Outcomes (8)

• Visual Plaque Index (VPI)

  12 months

• Visual Plaque Index (VPI)

  6 months

• Peridontal Pocket Depth (PPD)

  12 months

• Peridontal Pocket Depth (PPD)

  6 months

• KIPM (Keratinized Implant Peri-implant Mucosa Width)

  12 months

Study Arms (2)

TNC group

ACTIVE COMPARATOR

Standard oral hygiene.

Other: Standard oral hygiene

TNCL group

EXPERIMENTAL

Home-use antibacterial medical device.

Other: Standard oral hygiene; Device: The addition of home-based dual-light photodynamic therapy (Lumorinse® + Lumoral®)

Interventions

Standard oral hygiene OTHER

Standard protocol includes oral hygiene instructions (OHI), professional supragingival and subgingival instrumentation, and air polishing. A combination of manual tools (scalers/curettes) and electric tools (sonic/ultrasonic instruments) will be used to remove plaque and tartar, with particular attention to avoid damaging the implant surface. Both supragingival and subgingival surfaces will be treated with the air polishing device using glycine powder. A local antiseptic (1% chlorhexidine gel) will be prescribed twice daily for 7 days after TNC. OHI will be reinforced at each follow-up visit.

TNC group; TNCL group

The addition of home-based dual-light photodynamic therapy (Lumorinse® + Lumoral®) DEVICE

Lumorinse® is an effervescent tablet that provides a final concentration of indocyanine green (ICG) of 250 μg/mL when dissolved in 30 mL of water. After rinsing the mouth for 1 minute, the Lumoral® device is used to activate the ICG. The device consists of 48 LED lights in the shape of a mouthguard, which simultaneously provide antibacterial blue light (aBL) at 405 nm and near-infrared (NIR) LED light at 810 nm. In combination with the ICG photosensitizer, the device delivers simultaneous aBL and aPDT action on dental plaque. After 10 minutes of use (30 J/cm2 radiant exposure), the device automatically shuts off. After treatment, patients will follow regular home oral hygiene procedures according to the OHI provided.

TNCL group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Presence of at least 20 teeth within the oral cavity.
• Diagnosis of peri-implant mucositis: bleeding or suppuration upon gentle probing with or without increased probing depth compared to previous evaluations, and no bone loss beyond the changes in the crestal bone level resulting from initial bone remodeling.
• Patients willing and able to provide written informed consent.

You may not qualify if:

• Pregnancy.
• Patients with a history of periodontitis.
• Use of medications that could affect soft tissues within the past 6 months (e.g., antibiotics, anti-inflammatories, anticonvulsants, immunosuppressants, or calcium channel blockers, including doxycycline and bisphosphonates).
• Allergy to the photosensitizer.
• Patients with removable major prostheses or orthodontic appliances.
• Patients with untreated carious lesions.

Sponsors & Collaborators

• Koite Health Oy: lead
• University of Roma La Sapienza: collaborator

Study Sites (1)

Department of Oral and Maxillofacial Sciences, Sapienza Università di Roma,

Roma, 00161, Italy

RECRUITING

Related Publications (13)

• Nikinmaa S, Podonyi A, Raivio P, Meurman J, Sorsa T, Rantala J, Kankuri E, Tauriainen T, Patila T. Daily Administered Dual-Light Photodynamic Therapy Provides a Sustained Antibacterial Effect on Staphylococcus aureus. Antibiotics (Basel). 2021 Oct 13;10(10):1240. doi: 10.3390/antibiotics10101240.

  PMID: 34680821 BACKGROUND

• Nikinmaa S, Alapulli H, Auvinen P, Vaara M, Rantala J, Kankuri E, Sorsa T, Meurman J, Patila T. Dual-light photodynamic therapy administered daily provides a sustained antibacterial effect on biofilm and prevents Streptococcus mutans adaptation. PLoS One. 2020 May 6;15(5):e0232775. doi: 10.1371/journal.pone.0232775. eCollection 2020.

  PMID: 32374766 BACKGROUND

• Levine JI. Medications that increase photosensitivity. FDA document Dec 1990.

  BACKGROUND

• Gomes SC, Romagna R, Rossi V, Corvello PC, Angst PD. Supragingival treatment as an aid to reduce subgingival needs: a 450-day investigation. Braz Oral Res. 2014;28. doi: 10.1590/S1806-83242014.50000004.

  PMID: 25000595 BACKGROUND

• Alaijah, F., Morsi, A., Nasher, R. et al. Photobiomodulation therapy in the treatment of periodontal disease: a literature review. Laser Dent Sci 3, 147-153 (2019)

  BACKGROUND

• Slade GD. Derivation and validation of a short-form oral health impact profile. Community Dent Oral Epidemiol. 1997 Aug;25(4):284-90. doi: 10.1111/j.1600-0528.1997.tb00941.x.

  PMID: 9332805 BACKGROUND

• Nikinmaa S, Moilanen N, Sorsa T, Rantala J, Alapulli H, Kotiranta A, Auvinen P, Kankuri E, Meurman JH, Patila T. Indocyanine Green-Assisted and LED-Light-Activated Antibacterial Photodynamic Therapy Reduces Dental Plaque. Dent J (Basel). 2021 May 3;9(5):52. doi: 10.3390/dj9050052.

  PMID: 34063662 BACKGROUND

• Lahteenmaki H, Patila T, Raisanen IT, Kankuri E, Tervahartiala T, Sorsa T. Repeated Home-Applied Dual-Light Antibacterial Photodynamic Therapy Can Reduce Plaque Burden, Inflammation, and aMMP-8 in Peri-Implant Disease-A Pilot Study. Curr Issues Mol Biol. 2022 Mar 8;44(3):1273-1283. doi: 10.3390/cimb44030085.

  PMID: 35723308 BACKGROUND

• Lang NP, Suvan JE, Tonetti MS. Risk factor assessment tools for the prevention of periodontitis progression a systematic review. J Clin Periodontol. 2015 Apr;42 Suppl 16:S59-70. doi: 10.1111/jcpe.12350.

  PMID: 25496279 BACKGROUND

• Kassebaum NJ, Smith AGC, Bernabe E, Fleming TD, Reynolds AE, Vos T, Murray CJL, Marcenes W; GBD 2015 Oral Health Collaborators. Global, Regional, and National Prevalence, Incidence, and Disability-Adjusted Life Years for Oral Conditions for 195 Countries, 1990-2015: A Systematic Analysis for the Global Burden of Diseases, Injuries, and Risk Factors. J Dent Res. 2017 Apr;96(4):380-387. doi: 10.1177/0022034517693566.

  PMID: 28792274 BACKGROUND

• Kassebaum NJ, Bernabe E, Dahiya M, Bhandari B, Murray CJ, Marcenes W. Global burden of severe periodontitis in 1990-2010: a systematic review and meta-regression. J Dent Res. 2014 Nov;93(11):1045-53. doi: 10.1177/0022034514552491. Epub 2014 Sep 26.

  PMID: 25261053 BACKGROUND

• Jepsen S, Berglundh T, Genco R, Aass AM, Demirel K, Derks J, Figuero E, Giovannoli JL, Goldstein M, Lambert F, Ortiz-Vigon A, Polyzois I, Salvi GE, Schwarz F, Serino G, Tomasi C, Zitzmann NU. Primary prevention of peri-implantitis: managing peri-implant mucositis. J Clin Periodontol. 2015 Apr;42 Suppl 16:S152-7. doi: 10.1111/jcpe.12369.

  PMID: 25626479 BACKGROUND

• Berglundh T, Jepsen S, Stadlinger B, Terheyden H. Peri-implantitis and its prevention. Clin Oral Implants Res. 2019 Feb;30(2):150-155. doi: 10.1111/clr.13401. Epub 2019 Feb 3.

  PMID: 30636066 BACKGROUND

Related Links

• Pereira PAB, Aho VTE, Paulin L, et al., (2017) Oral and nasal microbiota in Parkinson's disease. Parkinsonism and Related Disorders 38: 61-67

Study Officials

• Alberto De Biase, Professor

  Department of Oral and Maxillofacial Sciences, Sapienza Università di Roma,

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mikko Kylmänen, Master of Health Care

CONTACT

+358407245934; mikko.kylmanen@koitehealth.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Patients will be randomly assigned to either the non-surgical treatment (TNC) group or the non-surgical treatment + Lumoral® (TNCL group) using sealed envelopes, with an equal number of envelopes for each treatment group. Each group will consist of 15 patients.

Study Record Dates

• First Submitted: February 28, 2025
• First Posted: March 5, 2025
• Study Start: April 29, 2025
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): February 1, 2027
• Last Updated: August 5, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)