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NCT Number: NCT06017817

Antibacterial Photodynamic Therapy in the Management of Peri-implantitis

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.

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Key information

Conditions

Peri-implantitis Dental Deposits Dental Plaque Mouth Diseases Periodontal Diseases Plaque, Dental Stomatognathic Diseases Tooth Diseases

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Södertandläkarna AB

Stockholm, 11622, Sweden

Location status: Recruiting

Location contact

Nilminie Rathnayake, Periodontist

CONTACT

About this study

Clinical signs of inflammation in peri-implantitis include bleeding on probing, suppuration, increased probing depth, and radiographic signs of bone loss. Currently, the best treatment options for peri-implantitis include non-surgical methods of biofilm removal in the supra-mucosal area around implants, and comprehensive guidance on self-performed infection control procedures. With more advanced peri-implantitis, anti-infective surgical treatment protocol would be needed.

Matrix metalloproteinase 8 (MMP-8) has been found to be elevated in association with oral infections, such as periodontitis and peri-implantitis. The level of active MMP-8 (aMMP-8) can detect to determine tissue health and to assess inflammation, and can easily be measured during a regular dental appointment with a chairside test.

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 method mechanism of action is antibacterial photodynamic therapy (aPDT). The method 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • Presence of any physical limitation or restriction that might restrict Lumoral use
  • Unwilling to participate in the study
  • Pregnancy or lactation
  • Active smoking
  • Medicated diabetes mellitus (DM)
  • Any systemic disease (e.g., wound healing dysfunctions) that could alter the progression of peri-implantitis
  • Use of antibiotics and doxycycline, chlorhexidine, and bisphosphonates, within 4 weeks week prior to study participation
  • Peri-implant and periodontal treatment within 3 months prior to study participation
  • Removable major prosthesis or major orthodontic appliance

Treatment and study plan

Lumoral Treatment

Device

Anti-infective photodynamic therapy for plaque-induced oral conditions

Standard oral hygiene instructions

Procedure

Standard oral hygiene instructions for electric toothbrushing, interdental brush, and dental floss use

Scaling and root planing (SRP

Procedure

non-surgical anti-infective treatment by scaling and root planing

surgical anti-infective peri-implantitis treatment

Procedure

surgical anti-infective peri-implantitis treatment

Primary outcomes

  1. Bleeding on probing (BOP)

    Time frame: 6 months

    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

Secondary outcomes

  1. Active matrix metalloproteinase 8 (aMMP-8)

    Time frame: 6 months

    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.

  2. Inflammatory marker total MMP-8 analysis

    Time frame: 6 months

    Measurement of pro and active MMP-8. Units: ng/ml.

  3. Inflammatory marker total MMP-9 analysis

    Time frame: 6 months

    Measurement of pro and active MMP-9. Units: ng/ml.

  4. Inflammatory marker total MMP-2 analysis

    Time frame: 6 months

    Measurement of pro and active MMP-2. Units: ng/ml.

  5. Inflammatory marker total TIMP analysis

    Time frame: 6 months

    Units: ng/ml.

  6. Interleukins analysis

    Time frame: 6 months

    Units: pg/ml.

  7. Total calprotectin analysis

    Time frame: 6 months

    Salivary calprotectin. Units: microgram/ml.

  8. Peridontal Pocket Depth (PPD)

    Time frame: 6 months

    A full-mouth assessment, measured at six sites per tooth. Assessed from the base of the pocket to the gingival margin (mm)

  9. Visual Plaque Index( VPI)

    Time frame: 6 months

    Assessment of six index teeth, measured at four sites per tooth

    • Dichotomous scoring to each site of the tooth as plaque "1 present" and "0 absent"
    • VPI reported as the percentage (%) of sites with plaque
    • Calculation formula: number of sites with plaque/ 4 times number of teeth

  10. Clinical Attachment Level (CAL)

    Time frame: 6 months

    A full-mouth assessment, measured at six sites per tooth

    • Assessed as the distance from the cementoenamel junction (CEJ) to the bottom of the periodontal pocket (mm)

    The measurements to calculate CAL:

    • distance from the gingival margin to the CEJ and PPD
    • in recession: PPD + gingival margin to the CEJ
    • in tissue overgrowth: PPD - gingival margin to the CEJ

  11. Bacterial flora

    Time frame: 6 Months

    Quantification of periodontopathic bacteria by 16S rRNA sequencing analysis

    • Microbiological samples can be collected using Iso Taper Paper Points, size-20 (VDW GmbH) from selected gingival/periodontal pockets with maximum initial probing depth. The paper points can be placed into sterile, small-aliquot containers, and immediately stored at -20°C until analysis

  12. Adverse events

    Time frame: 6 months

    Any suspicion of an adverse event related to the investigational device, the treatment method, or the study protocol.

  13. OHIP-14 questionnaire

    Time frame: 6 months

    • Measures people's perception of the social impact of oral disorders on their well-being.

    Fourteen items of OHIP are divided into seven dimensions: functional limitation, physical discomfort, psychological discomfort, physical disability, psychological disability, social disability, and handicaps. (Slade GD 1997). Responses are made on a 5-point scale (from 0 = never, to 4 = very often).

Other outcomes

  1. Mobility assessment

    Time frame: 6 months

    Manual assessment of the template movement, mobility testing sideways, and up and down

    • Scoring in numbers 0 - 3

  2. Suppuration index

    Time frame: 6 months

    • Visual assessment of the amount of pus, scoring: 0: No suppuration or exudate present
    • Minimal suppuration or exudate present
    • Moderate suppuration or exudate present
    • Severe suppuration or exudate present

Study contacts

Contact information is provided by the study sponsor or research team.

Mikko Kylmänen

CONTACT

[email protected]

+358407245934

Sponsors and collaborators

Lead sponsor

Nilminie Rathnayake

Industry

Collaborators

  • University of Helsinki

Registry information

Official study title

Regular Home-use of Antibacterial Photodynamic Therapy in the Management of Peri-implantitis

Important dates

Study start
2024
Primary completion
2025
Study completion
2026
First posted
Aug 30, 2023
Registry last updated
Oct 18, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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