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| Name | Class |
|---|---|
| University of Helsinki | OTHER |
| Metropolia University of Applied Sciences | OTHER |
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The study is a single site, randomized clinical trial designed to determine the efficacy of the Lumoral treatment in periodontitis patients.
Lumoral treatment is a CE-marked medical device developed to provide a potent, targeted antibacterial action on dental plaque in a home environment. The device mechanism of action is antibacterial photodynamic therapy. The device is used by swishing a mouth rinse, strongly adhering to dental plaque. The plaque-adhered photoactive mouth rinse can be activated by a simple use light applicator. The antibacterial efficacy far exceeds chlorhexidine, without side effects in long-term use. Preliminary results have shown a promising anti-inflammatory response in addition to plaque reduction.
This early-stage study is designed to determine the efficacy of the Lumoral method in periodontitis patients. 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lumoral treatment -device and Lumorinse tablets | Active Comparator | Subjects will receive detailed instructions for the use of Lumoral treatment -device and Lumorinse tablets. Subjects will be instructed to use the Lumoral treatment -device and follow the protocol once a day. |
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| Standard of Care | No Intervention | Subjects will receive oral hygiene instructions for the sonic toothbrushing and the use of interdental cleaning devices. They will not receive an additional intervention. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lumoral treatment -device and Lumorinse tablets | Device | Subjects will use Lumoral treatment -device and Lumorinse tablets daily as per protocol. |
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| Measure | Description | Time Frame |
|---|---|---|
| Bleeding on Probing (BOP) | Clinical change concerning bleeding on probing change. 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical Attachment Level (CAL) | Observation of clinical attachment level: 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). To calculate CAL, two measurements are needed: distance from the gingival margin to the CEJ and PPD; in recession: PPD + gingival margin to the CEJ; in tissue overgrowth: PPD - gingival margin to the CEJ. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Timo Sorsa, Professor | Univeristy of Helsinki | Principal Investigator |
| Tommi Pätilä, Docent | Koite Health | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Metropolia University of applied sciences | Helsinki | Finland |
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| ID | Term |
|---|---|
| D010518 | Periodontitis |
| D058225 | Plaque, Amyloid |
| ID | Term |
|---|---|
| D010510 | Periodontal Diseases |
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
| D020763 | Pathological Conditions, Anatomical |
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| 6 months |
| Periodontal 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 |
| Device-related adverse events | Absence of device-related serious adverse events or any patterns of device-related adverse events graded as moderate | 6 months |
| Inflammation marker aMMP-8 measurement | Change in aMMP8-measurement reflecting the reduction in periodontitis grade. 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 |
| Visual Plaque Index (VPI) | Assessment of six index teeth, measured at four sites per tooth Dichotomous scoring to each site of the tooth as plaque "1 present" and "0 absent" VPI reported as the percentage (%) of sites with plaque Calculation formula: number of sites with plaque/ 4 times number of teeth. | 6 months |
| OHIP-14 | Patient related objectives: Oral-related quality of life measurement (OHIP-14) questionnaire. | 6 months |
| Patient-related objective: PCS questionnaire | Measurements of internal motivation to dental hygiene by Perceived Competence Scale (PCS) questionnaire. | 6 months |
| Patient-related objective: OSCA questionnaire | Measurements of internal motivation to dental hygiene by Oral Self-Care Assessment (OSCA) questionnaire | 6 months |
| D013568 | Pathological Conditions, Signs and Symptoms |