Home Use of Dual-light Photodynamic Therapy for Chronic Periodontitis

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

41 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-01-19

Study Completion Date

2025-01-13

Brief Summary

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

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Detailed Description

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Periodontitis is a chronic inflammatory disease leading to a progressive loss of the tooth-supporting apparatus. The disease is strongly associated with deranged biodiversity patterns in dental plaque.

The Lumoral 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, which has a strong adherence to dental plaque. The plaque-adhered photoactive mouth rinse can be activated by a simple to use light applicator. The antibacterial efficacy far exceeds chlorhexidine, without side effects in a longterm use. Preliminary results have shown a promising anti-inflammatory response in addition to plaque reduction.

Ninety (90) stage I-III periodontitis patients are randomized to Lumoral treatment group or control group. Both groups shall receive mechanical plaque control by scaling and root planning (SRP) and standard oral hygiene instructions for electric toothbrush, interdental brush, and dental floss use. All the patients shall be assessed for the clinical periodontitis status. These assessment and analyses shall be performed at baseline, at 3 months and at 6 months after the treatment.

Conditions

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Periodontal Diseases Periodontitis Plaque, Dental Plaque Induced Gingivitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

90 participants are randomized into two arms: the Lumoral-treatment arm and Control arm.

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

The subjects will be randomized to the study group and the control group by using a sealed envelope system.

Study Groups

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Lumoral Treatment (Study group)

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 five to seven (5-7) times a week. Regular use shall be defined as frequency of a minimum of twice a week.

Standard oral hygiene instructions will be provided verbally and in writing. In addition, an electric toothbrush will be provided to all subjects.

Group Type EXPERIMENTAL

Lumoral treatment

Intervention Type DEVICE

The investigational Lumoral treatment -device provides a constant and repeatable application which can be done at home and is easily available. All subjects in the study group will receive their own Lumoral treatment -device and Lumorinse-mouth rinse tablets for the complete duration of the study.

Standard oral hygiene self care

Intervention Type OTHER

Both groups shall be given oral and written instructions for twice-daily standard oral hygiene self-care.

Standard of care (Control group)

Standard oral hygiene instructions will be provided verbally and in writing. In addition, an electric toothbrush will be provided to all subjects.

Group Type ACTIVE_COMPARATOR

Standard oral hygiene self care

Intervention Type OTHER

Both groups shall be given oral and written instructions for twice-daily standard oral hygiene self-care.

Interventions

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Lumoral treatment

The investigational Lumoral treatment -device provides a constant and repeatable application which can be done at home and is easily available. All subjects in the study group will receive their own Lumoral treatment -device and Lumorinse-mouth rinse tablets for the complete duration of the study.

Intervention Type DEVICE

Standard oral hygiene self care

Both groups shall be given oral and written instructions for twice-daily standard oral hygiene self-care.

Intervention Type OTHER

Other Intervention Names

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Lumorinse mouth rinse Electric toothbrush provided

Eligibility Criteria

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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, including implants
* 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

Exclusion Criteria

* Presence of major physical limitation or restriction that prohibit the hygiene procedures used in the study protocol
* Removable major prosthesis or major orthodontic appliance
* Pregnancy or lactation
* Use of antibiotics within 2 weeks prior the study
* A need for immediate antimicrobial treatment for periodontitis

Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No