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| Name | Class |
|---|---|
| University of Helsinki | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Non-surgical treatment, Study group (NST-1) | Experimental | Lumoral Treatment; Standard, non-surgical anti-infective treatment by scaling and root planing (SRP); and Standard oral hygiene instructions for electric toothbrushing, interdental brush, and dental floss use. |
|
| Non-surgical treatment, Control group (NST-2) | Active Comparator | Standard, non-surgical anti-infective treatment by scaling and root planing (SRP); and Standard oral hygiene instructions for electric toothbrushing, interdental brush, and dental floss use. |
|
| Surgical treatment, Study group (ST-1) | Experimental | Lumoral Treatment; Surgical anti-infective peri-implantitis treatment; and Standard oral hygiene instructions for electric toothbrushing, interdental brush, and dental floss use. |
|
| Surgical treatment, Control group (ST-2) | Active Comparator | Surgical anti-infective peri-implantitis treatment; and Standard oral hygiene instructions for electric toothbrushing, interdental brush, and dental floss use. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lumoral Treatment | Device | Anti-infective photodynamic therapy for plaque-induced oral conditions |
|
| Measure | Description | Time Frame |
|---|---|---|
| Bleeding on probing (BOP) | Change in the inflammatory parameter BOP. A full-mouth assessment at six sites per tooth:
| 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Active matrix metalloproteinase 8 (aMMP-8) | The oral rinse fluid sample collection and the aMMP-8 marker analysis will be performed using Periosafe test (Dentognostics GmbH) according to the manufacturer's instructions. | 6 months |
| Inflammatory marker total MMP-8 analysis |
| Measure | Description | Time Frame |
|---|---|---|
| Mobility assessment | Manual assessment of the template movement, mobility testing sideways, and up and down - Scoring in numbers 0 - 3 | 6 months |
| Suppuration index | - Visual assessment of the amount of pus, scoring: 0: No suppuration or exudate present
|
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Mikko Kylmänen | Contact | +358407245934 | mikko.kylmanen@koitehealth.com |
| Name | Affiliation | Role |
|---|---|---|
| Nilminie Rathnayake, Assoc Prof | University of Helsinki | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Södertandläkarna AB | Recruiting | Stockholm | 11622 | Sweden |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30636066 | 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. | |
| 25626479 | 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. |
| Label | URL |
|---|---|
| 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) | View source |
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| ID | Term |
|---|---|
| D057873 | Peri-Implantitis |
| D003773 | Dental Plaque |
| ID | Term |
|---|---|
| D010510 | Periodontal Diseases |
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
| D003741 | Dental Deposits |
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| ID | Term |
|---|---|
| D014080 | Tooth Exfoliation |
| D016745 | Root Planing |
| ID | Term |
|---|---|
| D009063 | Dental Physiological Phenomena |
| D055688 | Digestive System and Oral Physiological Phenomena |
| D012534 | Dental Scaling |
| D003777 | Dental Prophylaxis |
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80 subjects in total are recruited to this study: 40 subjects in the non-surgical treatment (NST), of which 20 participants in the NST Study group (NST-1) and 20 participants in the NST Control group (NST-2), and 40 subjects in the surgical treatment (ST), of which 20 participants in the ST Study group (ST-1) and 20 participants in the ST Control group (ST-2).
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The first assessments will be made before randomization.
After the randomization, there is no masking.
| Standard oral hygiene instructions | Procedure | Standard oral hygiene instructions for electric toothbrushing, interdental brush, and dental floss use |
|
| Scaling and root planing (SRP | Procedure | non-surgical anti-infective treatment by scaling and root planing |
|
| surgical anti-infective peri-implantitis treatment | Procedure | surgical anti-infective peri-implantitis treatment |
|
Measurement of pro and active MMP-8. Units: ng/ml. |
| 6 months |
| Inflammatory marker total MMP-9 analysis | Measurement of pro and active MMP-9. Units: ng/ml. | 6 months |
| Inflammatory marker total MMP-2 analysis | Measurement of pro and active MMP-2. Units: ng/ml. | 6 months |
| Inflammatory marker total TIMP analysis | Units: ng/ml. | 6 months |
| Interleukins analysis | Units: pg/ml. | 6 months |
| Total calprotectin analysis | Salivary calprotectin. Units: microgram/ml. | 6 months |
| Peridontal Pocket Depth (PPD) | A full-mouth assessment, measured at six sites per tooth. Assessed from the base of the pocket to the gingival margin (mm) | 6 months |
| Visual Plaque Index( VPI) | Assessment of six index teeth, measured at four sites per tooth
| 6 months |
| Clinical Attachment Level (CAL) | A full-mouth assessment, measured at six sites per tooth - Assessed as the distance from the cementoenamel junction (CEJ) to the bottom of the periodontal pocket (mm) The measurements to calculate CAL:
| 6 months |
| Bacterial flora | Quantification of periodontopathic bacteria by 16S rRNA sequencing analysis - Microbiological samples can be collected using Iso Taper Paper Points, size-20 (VDW GmbH) from selected gingival/periodontal pockets with maximum initial probing depth. The paper points can be placed into sterile, small-aliquot containers, and immediately stored at -20°C until analysis | 6 Months |
| Adverse events | Any suspicion of an adverse event related to the investigational device, the treatment method, or the study protocol. | 6 months |
| OHIP-14 questionnaire | - Measures people's perception of the social impact of oral disorders on their well-being. Fourteen items of OHIP are divided into seven dimensions: functional limitation, physical discomfort, psychological discomfort, physical disability, psychological disability, social disability, and handicaps. (Slade GD 1997). Responses are made on a 5-point scale (from 0 = never, to 4 = very often). | 6 months |
| 6 months |
| 25261053 | 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. |
| 28792274 | 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. |
| 25496279 | 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. |
| 35723308 | 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. |
| 34063662 | 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. |
| 9332805 | 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. |
| Gomes SC, Romagna R, Rossi V, Corvello PC, Melchiors-Angst PD. Supragingival treatment as an aid to reduce subgingival needs: a 450-day investigation Braz. oral res. 28 (1) 2014 | View source |
| Levine JI. Medications that increase photosensitivity. FDA document Dec 1990. | View source |
| Nikinmaa S, Alapulli H, Auvinen P, et al. (2020) Dual-light photodynamic therapy administered daily provides a sustained antibacterial effect on biofilm and prevents Streptococcus mutans adaptation. PLoS ONE 15(5) | View source |
| Pereira PAB, Aho VTE, Paulin L, et al., (2017) Oral and nasal microbiota in Parkinson's disease. Parkinsonism and Related Disorders 38: 61-67 | View source |
| D014076 |
| Tooth Diseases |
| D010517 | Periodontics |
| D003813 | Dentistry |
| D013357 | Subgingival Curettage |
| D011313 | Preventive Dentistry |