Antibacterial Photodynamic Therapy in the Management of Peri-implantitis
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-85
SponsorKoite Health Oy
About this trial
This early-stage study is designed to determine the efficacy of the Lumoral method in periimplantitis. Improved supragingival plaque control can help to also sustain subgingival plaque management in the long term. In addition, the device might have a photobiomodulation effect on periodontal tissues, thus impacting osseointegration.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
PPD ≥6 mm and marginal bone loss >3 mm
Dental implants collected and clinically characterized according to Lähteenmäki et al. CEDR-22
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
Disqualifiers
Presence of any physical limitation or restriction that might restrict Lumoral use
Unwilling to participate in the study
Pregnancy or lactation
Active smoking
Trial design
Design model
Parallel
Treatments tested in this trial
Lumoral Treatment
DeviceAnti-infective photodynamic therapy for plaque-induced oral conditions
Standard oral hygiene instructions
Procedure/SurgeryStandard oral hygiene instructions for electric toothbrushing, interdental brush, and dental floss use
Scaling and root planing (SRP
Procedure/Surgerynon-surgical anti-infective treatment by scaling and root planing
surgical anti-infective peri-implantitis treatment
Procedure/Surgerysurgical anti-infective peri-implantitis treatment
Treatment groups
80 Participants
are divided into 4 treatment groupsGroup A: Non-surgical treatment, Study group (NST-1)Experimental treatment 3 interventions
Group B: Non-surgical treatment, Control group (NST-2)Active comparator 2 interventions
Group C: Surgical treatment, Study group (ST-1)Experimental treatment 3 interventions
Group D: Surgical treatment, Control group (ST-2)Active comparator 2 interventions
Trial outcomes
Primary outcomes
1
Bleeding on probing (BOP)
Change in the inflammatory parameter BOP. A full-mouth assessment at six sites per tooth: * Gingival bleeding is considered as positive if bleeding occurs within 15 seconds after gentle probing with a probe at the sulcus * Dichotomous scoring to each site of the tooth as bleeding "1 present" and "0 absent" * BOP reported as the percentage (%) of sites with positive findings * Calculation formula: number of bleeding sites/ 6 times number of teeth
Time frame
6 monthsSecondary outcomes
1
Active matrix metalloproteinase 8 (aMMP-8)
The oral rinse fluid sample collection and the aMMP-8 marker analysis will be performed using Periosafe test (Dentognostics GmbH) according to the manufacturer's instructions.
Time frame
6 months2
Inflammatory marker total MMP-8 analysis
Measurement of pro and active MMP-8. Units: ng/ml.
Time frame
6 months3
Inflammatory marker total MMP-9 analysis
Measurement of pro and active MMP-9. Units: ng/ml.
Time frame
6 months4
Inflammatory marker total MMP-2 analysis
Measurement of pro and active MMP-2. Units: ng/ml.
Time frame
6 monthsOther outcomes
1
Mobility assessment
Manual assessment of the template movement, mobility testing sideways, and up and down \- Scoring in numbers 0 - 3
Time frame
6 months2
Suppuration index
\- Visual assessment of the amount of pus, scoring: 0: No suppuration or exudate present 1. Minimal suppuration or exudate present 2. Moderate suppuration or exudate present 3. Severe suppuration or exudate present
Time frame
6 monthsSponsors and contacts
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Source ClinicalTrials.gov