Regular Home Use of Dual-light Photodynamic Therapy in the Management of Chronic Periodontitis (HOPE-CP)
Primary Purpose
Periodontitis
Status
Recruiting
Phase
Not Applicable
Locations
Finland
Study Type
Interventional
Intervention
Lumoral treatment -device and Lumorinse tablets
Sponsored by
About this trial
This is an interventional prevention trial for Periodontitis focused on measuring Lumoral, Lumorinse, Periodontitis, Anti-bacterial photodynamic therapy, aPDT, Plaque, aMMP-8
Eligibility Criteria
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
Sites / Locations
- Metropolia University of applied sciencesRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
No Intervention
Arm Label
Lumoral treatment -device and Lumorinse tablets
Standard of Care
Arm Description
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.
Subjects will receive oral hygiene instructions for the sonic toothbrushing and the use of interdental cleaning devices. They will not receive an additional intervention.
Outcomes
Primary Outcome Measures
Plaque index
Plaque measurement
Bleeding
Clinical change concerning bleeding on probing change
pocket depth
measurement of pocket depth
Clinical attachment level
observation of clinical attachment
Secondary Outcome Measures
Change in clinical parameters
Change in aMMP8-measurement reflecting the reduction in periodontitis grade.
Full Information
NCT ID
NCT05278416
First Posted
February 7, 2022
Last Updated
January 30, 2023
Sponsor
Koite Health Oy
Collaborators
University of Helsinki
1. Study Identification
Unique Protocol Identification Number
NCT05278416
Brief Title
Regular Home Use of Dual-light Photodynamic Therapy in the Management of Chronic Periodontitis
Acronym
HOPE-CP
Official Title
Regular Home Use of Dual-light Photodynamic Therapy in the Management of Chronic Periodontitis.
Study Type
Interventional
2. Study Status
Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 8, 2022 (Actual)
Primary Completion Date
July 31, 2024 (Anticipated)
Study Completion Date
November 30, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Koite Health Oy
Collaborators
University of Helsinki
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The study is a single site, randomized clinical trial designed to determine the efficacy of the Lumoral treatment in periodontitis patients.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Periodontitis
Keywords
Lumoral, Lumorinse, Periodontitis, Anti-bacterial photodynamic therapy, aPDT, Plaque, aMMP-8
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
200 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Lumoral treatment -device and Lumorinse tablets
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Standard of Care
Arm Type
No Intervention
Arm Description
Subjects will receive oral hygiene instructions for the sonic toothbrushing and the use of interdental cleaning devices. They will not receive an additional intervention.
Intervention Type
Device
Intervention Name(s)
Lumoral treatment -device and Lumorinse tablets
Intervention Description
Subjects will use Lumoral treatment -device and Lumorinse tablets daily as per protocol.
Primary Outcome Measure Information:
Title
Plaque index
Description
Plaque measurement
Time Frame
6 months
Title
Bleeding
Description
Clinical change concerning bleeding on probing change
Time Frame
6 months
Title
pocket depth
Description
measurement of pocket depth
Time Frame
6 months
Title
Clinical attachment level
Description
observation of clinical attachment
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Change in clinical parameters
Description
Change in aMMP8-measurement reflecting the reduction in periodontitis grade.
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mikko Kylmänen
Phone
+358407245934
Email
mikko.kylmanen@koitehealth.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Timo Sorsa, Professor
Organizational Affiliation
Univeristy of Helsinki
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Tommi Pätilä, Docent
Organizational Affiliation
Koite Health
Official's Role
Study Director
Facility Information:
Facility Name
Metropolia University of applied sciences
City
Helsinki
Country
Finland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mikko Kylmänen
Phone
+358407245934
Email
mikko.kylmanen@koitehealth.com
First Name & Middle Initial & Last Name & Degree
Timo Sorsa, Professor
First Name & Middle Initial & Last Name & Degree
Saila Pakarinen, DDS
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Regular Home Use of Dual-light Photodynamic Therapy in the Management of Chronic Periodontitis
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