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RecruitingNot ApplicableNCT06017817

Antibacterial Photodynamic Therapy in the Management of Peri-implantitis

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

Sponsor

Nilminie Rathnayake

Enrollment

80 participants

Start Date

May 13, 2024

Study Type

INTERVENTIONAL

Summary

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

Min Age: 18 YearsMax Age: 85 Years

Inclusion Criteria4

  • 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 Criteria9

  • 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

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Interventions

DEVICELumoral Treatment

Anti-infective photodynamic therapy for plaque-induced oral conditions

PROCEDUREStandard oral hygiene instructions

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

PROCEDUREScaling and root planing (SRP

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

PROCEDUREsurgical anti-infective peri-implantitis treatment

surgical anti-infective peri-implantitis treatment

Locations(1)

Södertandläkarna AB

Stockholm, Sweden

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NCT06017817