Antibacterial Photodynamic Therapy in the Management of Peri-implantitis

Nilminie Rathnayake

Status: Enrolling

Conditions: Peri-Implantitis; Plaque, Dental

Treatments: Device: Lumoral Treatment; Procedure: Standard oral hygiene instructions; Procedure: surgical anti-infective peri-implantitis treatment; Procedure: Scaling and root planing (SRP

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT06017817

HEALTHIER

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 80 estimated patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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80 participants in 4 patient groups

Non-surgical treatment, Study group (NST-1)

Experimental group

Description:

Lumoral Treatment; Standard, non-surgical anti-infective treatment by scaling and root planing (SRP); and Standard oral hygiene instructions for electric toothbrushing, interdental brush, and dental floss use.

Treatment:

Procedure: Scaling and root planing (SRP

Procedure: Standard oral hygiene instructions

Device: Lumoral Treatment

Non-surgical treatment, Control group (NST-2)

Active Comparator group

Description:

Standard, non-surgical anti-infective treatment by scaling and root planing (SRP); and Standard oral hygiene instructions for electric toothbrushing, interdental brush, and dental floss use.

Treatment:

Procedure: Scaling and root planing (SRP

Procedure: Standard oral hygiene instructions

Surgical treatment, Study group (ST-1)

Experimental group

Description:

Lumoral Treatment; Surgical anti-infective peri-implantitis treatment; and Standard oral hygiene instructions for electric toothbrushing, interdental brush, and dental floss use.

Treatment:

Procedure: surgical anti-infective peri-implantitis treatment

Procedure: Standard oral hygiene instructions

Device: Lumoral Treatment

Surgical treatment, Control group (ST-2)

Active Comparator group

Description:

Surgical anti-infective peri-implantitis treatment; and Standard oral hygiene instructions for electric toothbrushing, interdental brush, and dental floss use.

Treatment:

Procedure: surgical anti-infective peri-implantitis treatment

Procedure: Standard oral hygiene instructions