Antibacterial Photodynamic Therapy in the Management of Peri-implantitis

Официальное название

Regular Home-use of Antibacterial Photodynamic Therapy in the Management of Peri-implantitis

Обзор

This early-stage study is designed to determine the efficacy of the Lumoral method in periimplantitis. Improved supragingival plaque control can help to also sustain subgingival plaque management in the long term. In addition, the device might have a photobiomodulation effect on periodontal tissues, thus impacting osseointegration.

Подробное описание

Clinical signs of inflammation in peri-implantitis include bleeding on probing, suppuration, increased probing depth, and radiographic signs of bone loss. Currently, the best treatment options for peri-implantitis include non-surgical methods of biofilm removal in the supra-mucosal area around implants, and comprehensive guidance on self-performed infection control procedures. With more advanced peri-implantitis, anti-infective surgical treatment protocol would be needed.

Matrix metalloproteinase 8 (MMP-8) has been found to be elevated in association with oral infections, such as periodontitis and peri-implantitis. The level of active MMP-8 (aMMP-8) can detect to determine tissue health and to assess inflammation, and can easily be measured during a regular dental appointment with a chairside test.

The Lumoral Treatment is a CE-marked medical device developed to provide a potent, targeted antibacterial action on dental plaque in a home environment. The method mechanism of action is antibacterial photodynamic therapy (aPDT). The method is used by swishing a mouth rinse, which has a strong adherence to dental plaque. The plaque-adhered photoactive mouth rinse can be activated by a simple-to-use light applicator. Preliminary results have shown a promising anti-inflammatory response in addition to plaque reduction.

Вмешательства

• Устройство Lumoral Treatment
  Anti-infective photodynamic therapy for plaque-induced oral conditions
• Процедура Standard oral hygiene instructions
  Standard oral hygiene instructions for electric toothbrushing, interdental brush, and dental floss use
• Процедура Scaling and root planing (SRP
  non-surgical anti-infective treatment by scaling and root planing
• Процедура surgical anti-infective peri-implantitis treatment
  surgical anti-infective peri-implantitis treatment

Первичные конечные точки

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

Вторичные конечные точки (12)

• Active matrix metalloproteinase 8 (aMMP-8) [Срок оценки: 6 months]
• Inflammatory marker total MMP-8 analysis [Срок оценки: 6 months]
• Inflammatory marker total MMP-9 analysis [Срок оценки: 6 months]
• Inflammatory marker total MMP-2 analysis [Срок оценки: 6 months]
• Inflammatory marker total TIMP analysis [Срок оценки: 6 months]
• Interleukins analysis [Срок оценки: 6 months]
• Total calprotectin analysis [Срок оценки: 6 months]
• Peridontal Pocket Depth (PPD) [Срок оценки: 6 months]
• Visual Plaque Index( VPI) [Срок оценки: 6 months]
• Clinical Attachment Level (CAL) [Срок оценки: 6 months]
• Bacterial flora [Срок оценки: 6 Months]
• Adverse events [Срок оценки: 6 months]

Критерии участия

Критерии включения

• PPD ≥6 mm and marginal bone loss >3 mm
• Dental implants collected and clinically characterized according to Lähteenmäki et al. CEDR-22
• Agreement to participate in the study and to sign a written consent form
• Able to co-operate with the treatment protocol and avoid any other oral hygiene measures outside of the study protocol

Критерии исключения

• Presence of any physical limitation or restriction that might restrict Lumoral use
• Unwilling to participate in the study
• Pregnancy or lactation
• Active smoking
• Medicated diabetes mellitus (DM)
• Any systemic disease (e.g., wound healing dysfunctions) that could alter the progression of peri-implantitis
• Use of antibiotics and doxycycline, chlorhexidine, and bisphosphonates, within 4 weeks week prior to study participation
• Peri-implant and periodontal treatment within 3 months prior to study participation
• Removable major prosthesis or major orthodontic appliance

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

Двойное слепое

Основная цель

Лечение

Центры проведения

Швеция · 1 центр

• Södertandläkarna AB — Stockholm

Публикации

• 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
• 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
• 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
• 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 PMID 28792274
• 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
• 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
• 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
• 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

Идентификаторы

NCT: NCT06017817 · HEALTHIER

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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