Regular Home Use of Dual-light Photodynamic Therapy in the Management of Chronic Periodontitis (HOPE-CP)
Regular Home Use of Dual-light Photodynamic Therapy in the Management of Chronic Periodontitis.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Helsinki, Finland
- Metropolia University of Applied Sciences
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Periodontal disease stage I-III, according to criteria the American Academy of Periodontology (AAP) with at least 2 mm interdental CAL in the site of greatest loss
- Age of 18-85 years
- Presence of > 20 teeth
- Agreement to participate in the study and to sign a written consent form
Exclusion Criteria:
- Untreated/uncontrollable diabetes mellitus (DM) with HbA1c >7%, and HbA1c > 8 if insulin treated DM
- Any systemic disease (e.g., wound healing dysfunctions) that could alter the progression of periodontal disease
- Use of medicine that would affect the periodontal tissue within the last 6 months (antibiotics, anti-inflammatories, anticonvulsants, immunosuppressants, or calcium channel blockers, including doxycycline, bisphosphonates and chlorhexidine)
- Periodontal treatment during the previous 3 months
- Allergic to the photosensitizer
- Presence of major physical limitation or restriction that prohibit the hygiene procedures used in the study protocol
- Removable major prosthesis or major orthodontic appliance
- Active smoking, or habitual use of smokeless tobacco products
- Pregnancy or lactation
- A need for a hopeless teeth extraction, or open cavities in need for immediate endodontic treatment
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Active Comparator: Lumoral treatment -device and Lumorinse tablets
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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Subjects will use Lumoral treatment -device and Lumorinse tablets daily as per protocol.
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No Intervention: Standard of Care
Subjects will receive oral hygiene instructions for the sonic toothbrushing and the use of interdental cleaning devices.
They will not receive an additional intervention.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Bleeding on Probing (BOP)
Time Frame: 6 months
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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.
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6 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Periodontal Pocket Depth (PPD)
Time Frame: 6 months
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A full-mouth assessment, measured at six sites per tooth.
Assessed from the base of the pocket to the gingival margin (mm)
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6 months
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Clinical Attachment Level (CAL)
Time Frame: 6 months
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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. |
6 months
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Device-related adverse events
Time Frame: 6 months
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Absence of device-related serious adverse events or any patterns of device-related adverse events graded as moderate
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6 months
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Inflammation marker aMMP-8 measurement
Time Frame: 6 months
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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.
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6 months
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Visual Plaque Index (VPI)
Time Frame: 6 months
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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
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OHIP-14
Time Frame: 6 months
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Patient related objectives: Oral-related quality of life measurement (OHIP-14) questionnaire.
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6 months
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Patient-related objective: PCS questionnaire
Time Frame: 6 months
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Measurements of internal motivation to dental hygiene by Perceived Competence Scale (PCS) questionnaire.
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6 months
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Patient-related objective: OSCA questionnaire
Time Frame: 6 months
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Measurements of internal motivation to dental hygiene by Oral Self-Care Assessment (OSCA) questionnaire
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6 months
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Collaborators and Investigators
Sponsor
Investigators
- Study Director: Tommi Pätilä, Docent, Koite Health
- Principal Investigator: Timo Sorsa, Professor, Univeristy of Helsinki
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- KHE2021Metro (HOPE-CP)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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