Clinical trial NCT05825742: Regular Home Use of Dual-light Photodynamic Therapy on Oral Health in Adolescents Undergoing Fixed Orthodontic Treatment
Official title: Efficacy of Regular Home Use of Dual-light Photodynamic Therapy on Oral Health in Adolescents Undergoing Fixed Orthodontic Treatment - Randomized, Controlled Clinical Study
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Orthodontic Appliance Complication
Plaque, Dental
Gingival Inflammation
Lead sponsor: Koite Health Oy
Sponsor class: INDUSTRY
Collaborators: name: University of Helsinki
name: Helsinki University Central Hospital
name: Borgska Villans Specialisttandvård
First posted: 2023-04-24
Enrollment: 40
Sex: ALL
Minimum age (years): 15
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants in two groups (Study group and Control group) shall receive instructions for standard oral hygiene. The same assessments are done for participants in both groups, and within the same time periods. The Study group will also be using the Lumoral Treatment device.
Primary purpose: TREATMENT

Brief summary: This study is designed to determine the efficacy of the Lumoral method on oral health in adolescents undergoing fixed orthodontic treatment. 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.

Detailed description: Orthodontic treatment is one of the most common dental treatments in children and adolescents. The use of fixed orthodontic appliances makes it difficult for the patients to keep their oral hygiene to an optimum level of cleanliness. Poor oral hygiene attracts significant plaque accumulation around the fixed orthodontic treatment appliances, and subsequent white spot lesions can occur rapidly, usually on the cervical and middle third of the buccal surfaces of bracketed teeth. Patients with the fixed orthodontic treatment appliances have an increased risk of caries and gingivitis.

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 (aPDT). 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. Preliminary results have shown a promising anti-inflammatory response in addition to plaque reduction.

Forty (40) subjects undergoing fixed orthodontic treatment are randomized to the Lumoral treatment group or the control group. All subjects shall receive polishing and oral hygiene instruction. All patients shall be assessed for the clinical measurements including visible plaque index (VPI), bleeding on probing (BOP), and orthodontic plaque index (OPI) at baseline and at 4 weeks and 12 weeks after baseline. In addition, microbiological analyses shall be performed at baseline and at 12 weeks after baseline.

Eligibility criteria: Inclusion Criteria:

* age of 15-18 years old
* starting fixed orthodontic treatment
* good oral hygiene according to the dentist's assessment
* absence of periodontal disease and lack of oral lesion
* signed a written consent form, including information to caregivers.

Exclusion Criteria:

* any chronic diseases
* medications that could influence the study (according to the dentists' assessment)
* active caries or a supposed high risk of caries
* gingivitis (bleeding on probing \>10%)
* use of antiseptic mouthwashes
* smoking
* use of antibiotics or anti-inflammatory therapy within 3 months before entering the study or during the study
* unable to cooperate with the protocol.
* pregnancy or lactation

Primary outcomes:
measure: Change in Visible plaque index (VPI)
timeFrame: 12 weeks
Secondary outcomes:
measure: Change in Bleeding on probing (BOP)
timeFrame: 12 weeks
measure: Change in Orthodontic plaque index (OPI)
timeFrame: 12 weeks
measure: Change in periodontal microbiological flora
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Lund
country: Sweden
facility: Borgska Villans Specialisttandvård
Study officials:
affiliation: Borgska Villans Specialisttandvård
name: Ann-Marie Roos Jansåker, Professor
role: PRINCIPAL_INVESTIGATOR
affiliation: Koite Health
name: Tommi Pätilä, Docent
role: STUDY_DIRECTOR
References:
citation: Erbe C, Klees V, Braunbeck F, Ferrari-Peron P, Ccahuana-Vasquez RA, Timm H, Grender J, Cunningham P, Adam R, Wehrbein H. Comparative assessment of plaque removal and motivation between a manual toothbrush and an interactive power toothbrush in adolescents with fixed orthodontic appliances: A single-center, examiner-blind randomized controlled trial. Am J Orthod Dentofacial Orthop. 2019 Apr;155(4):462-472. doi: 10.1016/j.ajodo.2018.12.013.
citation: Nikinmaa S, Moilanen N, Sorsa T, Rantala J, Alapulli H, Kotiranta A, Auvinen P, Kankuri E, Meurman JH, Patila T. Indocyanine Green-Assisted and LED-Light-Activated Antibacterial Photodynamic Therapy Reduces Dental Plaque. Dent J (Basel). 2021 May 3;9(5):52. doi: 10.3390/dj9050052.
citation: Verrusio C, Iorio-Siciliano V, Blasi A, Leuci S, Adamo D, Nicolo M. The effect of orthodontic treatment on periodontal tissue inflammation: A systematic review. Quintessence Int. 2018;49(1):69-77. doi: 10.3290/j.qi.a39225.
citation: Walsh LJ, Healey DL. Prevention and caries risk management in teenage and orthodontic patients. Aust Dent J. 2019 Jun;64 Suppl 1:S37-S45. doi: 10.1111/adj.12671.