Investigation of the effectiveness of a light device called Lumoral for antibacterial photodynamic therapy in patients undergoing supportive periodontal therapy
Résumé de l'étude
In this study, we aim to find out whether the additional application of a special light device called "Lumoral" can effectively reduce bacteria in the mouth of patients undergoing supportive periodontal therapy in addition to the treatment. 60 patients will be randomly divided into two groups. One group will use the Lumoral device for 4 additional days according to the instructions after the usual dental hygiene session at home, while the other group will not use the Lumoral device. After 8 weeks, we will compare the bacteria and inflammation in both groups, without knowing who was in which group. Our goal is to determine whether the light device can better remove bacteria and reduce gum inflammation.
(BASEC)
Intervention étudiée
The intervention being studied is the application of a light device called "Lumoral" for antibacterial photodynamic therapy (aPDT). The Lumoral light device is a medical product that uses a combination of antibacterial blue light and a photosensitizing agent (dye as a rinse). By targeting bacterial biofilms with blue light, the agent is activated, releasing oxygen radicals that kill bacteria. The Lumoral device is designed for self-application at home. In the test group, patients are instructed to use the Lumoral light device for 4 consecutive days according to the instructions.
(BASEC)
Maladie en cours d'investigation
This study will be conducted with patients who have treated periodontitis. Periodontitis is an inflammatory disease of the tooth-supporting apparatus caused by bacteria in dental plaque. If the bacteria in the dental plaque and in the pocket between the tooth and gum are left untreated, the inflammation can spread and lead to tissue destruction in the jawbone and eventual tooth loss. Although thorough mechanical cleaning of the teeth can reduce the risk of periodontitis, it is sometimes difficult for patients to clean all affected areas themselves.
(BASEC)
- adult (at least 18 years old) - undergoing supportive periodontal therapy - pocket depths not deeper than 6 mm - Oral bleeding index of ≤ 30% - Signed study information (BASEC)
Critères d'exclusion
- Severe systemic diseases - Smoking more than 10 cigarettes/day - Pregnant or breastfeeding (BASEC)
Lieu de l’étude
Berne
(BASEC)
Sponsor
None
(BASEC)
Contact pour plus d'informations sur l'étude
Personne de contact en Suisse
Christopf Ramseier
+41316840620
christoph.ramseier@clutterunibe.chUniversity of Bern
(BASEC)
Informations scientifiques
non disponible
Nom du comité d'éthique approbateur (pour les études multicentriques, uniquement le comité principal)
Commission cantonale d'éthique de Berne
(BASEC)
Date d'approbation du comité d'éthique
12.11.2024
(BASEC)
Identifiant de l'essai ICTRP
non disponible
Titre officiel (approuvé par le comité d'éthique)
Clinical outcomes following dual-light photodynamic therapy administered daily during supportive periodontal therapy: an 8-week randomized clinical trial (BASEC)
Titre académique
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Titre public
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Maladie en cours d'investigation
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Intervention étudiée
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Type d'essai
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Plan de l'étude
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Critères d'inclusion/exclusion
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Critères d'évaluation principaux et secondaires
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Date d'enregistrement
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Inclusion du premier participant
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Sponsors secondaires
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Contacts supplémentaires
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ID secondaires
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Résultats-Données individuelles des participants
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Informations complémentaires sur l'essai
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Résultats de l'essai
Résumé des résultats
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Lien vers les résultats dans le registre primaire
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