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

Официальное название

Efficacy of Adjunctive At-Home Photodynamic Therapy (aPDT) in the Treatment of Peri-Implant Mucositis: A Post-Marketing Interventional Pilot Study With a Medical Device

Обзор

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).

Подробное описание

Dental implants offer an opportunity to restore oral health by replacing missing teeth, demonstrating exceptional longevity when properly maintained. The maintenance of implant health primarily depends on the effective removal of dental plaque, which is the primary cause of periodontal diseases, from both dental and prosthetic surfaces.

According to an accepted definition, peri-implant mucositis is an inflammation of the peri-implant mucosa without loss of supporting bone tissue, while peri-implantitis is characterized by inflammation of the peri-implant mucosa associated with supporting bone loss. Recent data indicate that a significant proportion, ranging from 50% to 90%, of implants are affected by peri-implant mucositis.

The diagnosis of peri-implant mucositis is currently based on clinical observations; however, clinical evaluations may yield false positives or fail to allow early diagnosis and timely treatment of pathological conditions. With the knowledge of the current restrictions, this study aims to evaluate the levels of active matrix metalloproteinase-8 (aMMP-8) derived from Peri-Implant Sulcular Fluid (PISF), which is one of the most precise and sensitive diagnostic markers of peri-implant tissue inflammation.

The treatment of peri-implant mucositis currently encompasses a range of professional and at-home measures. Typically, peri-implant mucositis precedes the characteristic bone loss of peri-implantitis; therefore, the timely treatment of clinical signs of inflammation is critical to prevent disease progression that could culminate in implant failure. Inadequate plaque removal increases the risk of peri-implantitis by hindering access to implant sites for oral hygiene, resulting in a higher incidence in areas that patients are unable to clean effectively compared to easily accessible sites, underscoring the importance of focusing on at-home dental care.

New methods for at-home oral care are under development, such as antimicrobial photodynamic therapy (aPDT), which utilizes a photosensitizer (PS) and low-intensity visible light to generate reactive oxygen species (ROS) that target pathogenic bacteria. Antibacterial blue light takes advantage of the intrinsic antimicrobial properties derived from endogenous photosensitizing chromophores of pathogenic microbes, eliminating the need for exogenous dyes.

Вмешательства

• Другое Standard oral hygiene
  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) w
• Устройство The addition of home-based dual-light photodynamic therapy (Lumorinse® + Lumoral®)
  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 an

Первичные конечные точки

• Bleeding on probing (BOP) [Срок оценки: 12 months]
• Bleeding on probing (BOP) [Срок оценки: 6 months]

Вторичные конечные точки (8)

• Visual Plaque Index (VPI) [Срок оценки: 12 months]
• Visual Plaque Index (VPI) [Срок оценки: 6 months]
• Peridontal Pocket Depth (PPD) [Срок оценки: 12 months]
• Peridontal Pocket Depth (PPD) [Срок оценки: 6 months]
• KIPM (Keratinized Implant Peri-implant Mucosa Width) [Срок оценки: 12 months]
• KIPM (Keratinized Implant Peri-implant Mucosa Width) [Срок оценки: 6 months]
• Biomolecular Analysis [Срок оценки: 12 months]
• Biomolecular Analysis [Срок оценки: 6 months]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

Италия · 1 центр

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

Публикации

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

Идентификаторы

NCT: NCT06859866 · PhoPIM

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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