Regular Home-use of Dual-light Photodynamic Therapy in the Management of Chronic Stage III-IV 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

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-06-06

Study Completion Date

2027-12-31

Brief Summary

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This study is designed to determine the efficacy of the Lumoral method in chronic periodontitis with a targeted group of stage III and IV periodontitis.

Improved supragingival plaque control can help to also sustain the subgingival plaque management in the long term.

In addition, the method might have a photobiomodulation effect on periodontal tissues.

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Detailed Description

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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 device mechanism of action is antibacterial photodynamic therapy (aPDT). The device is used by swishing a specially designed mouth rinse that strongly adheres to dental plaque. The plaque-adhered photoactive mouth rinse can be activated by a simple-to-use light applicator. Preliminary results have shown promising anti-inflammatory responses in addition to plaque reduction.

Conditions

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Periodontitis Chronic Generalized Moderate Periodontitis Chronic Generalized Severe

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

All clinical assessments at baseline and at 6 months shall be performed by one calibrated examiner who is blinded for the subjects' allocation to the study and control groups.

Study Groups

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Study group

A complete clinical intraoral examination shall be performed for all subjects. Same demographic and clinical data will be obtained from subjects in both arms. The study group shall receive the Lumoral treatment -device, Lumorinse -tablets and instructions for their use.

All subjects shall receive standard oral hygiene instructions for the use of an electric toothbrush, interdental brush, and dental floss.

Group Type EXPERIMENTAL

Lumoral Treatment

Intervention Type DEVICE

The Lumoral treatment -device is a CE-marked antibacterial home-use device for the treatment and prevention of oral diseases caused by bacteria. It is used in combination with a CE-marked mouth rinse called Lumorinse.

Control group

A complete clinical intraoral examination shall be performed for all subjects. Same demographic and clinical data will be obtained from subjects in both arms. All subjects shall receive standard oral hygiene instructions for the use of an electric toothbrush, interdental brush, and dental floss.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Lumoral Treatment

The Lumoral treatment -device is a CE-marked antibacterial home-use device for the treatment and prevention of oral diseases caused by bacteria. It is used in combination with a CE-marked mouth rinse called Lumorinse.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Periodontal disease stage III-IV, according to criteria the American Academy of Periodontology (AAP) with at least 3 mm interdental clinical attachment level (CAL) in the site of greatest loss.
* ≥ 18 years old
* 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

* Grade A or C periodontitis
* Presence of any physical limitation or restriction that might restrict Lumoral use
* Pregnancy or lactation
* Active smoking
* Medicated diabetes mellitus (DM)
* Any systemic disease (e.g., wound healing dysfunctions) that could alter the progression of periodontal disease
* Use of antibiotics within 4 weeks week prior study
* Periodontal treatment within 3 months prior study
* Removable major prosthesis or major orthodontic appliance
* A need for a hopeless teeth extraction, or open cavities in need for immediate endodontic treatment

Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No