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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.
Periodontitis Chronic Generalized Moderate
Periodontitis Chronic Generalized Severe
Lumoral Treatment
Not Applicable
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.}}
| Study Type : | Interventional |
| Estimated Enrollment : | 60 participants |
| Masking : | Single |
| Masking Description : | 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. |
| Primary Purpose : | Treatment |
| Official Title : | Regular Home-use of Dual-light Photodynamic Therapy in the Management of Chronic Stage III-IV Periodontitis |
| Actual Study Start Date : | June 6, 2023 |
| Estimated Primary Completion Date : | May 31, 2025 |
| Estimated Study Completion Date : | December 31, 2027 |
| Arm | Intervention/treatment |
|---|---|
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Experimental: 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. |
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No Intervention: 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. |
| Ages Eligible for Study: | 18 Years to 85 Years |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.
Recruiting
Hospital of Lithuanian University of Health Sciences Kaunas Clinics, Department of Dental and Oral Pathology
Kaunas, Lithuania, 50161