Antibacterial Photodynamic Therapy in the Management of Peri-implantitis

Sponsor

Nilminie Rathnayake (Industry)

Overall Status

Not yet recruiting

CT.gov ID

NCT06017817

Collaborator

University of Helsinki (Other)

Enrollment

Location

Arms

Anticipated Duration (Months)

2.1

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Peri-Implantitis Plaque, Dental	Device: Lumoral Treatment Procedure: Standard oral hygiene instructions Procedure: Scaling and root planing (SRP Procedure: surgical anti-infective peri-implantitis treatment	N/A

Detailed 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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

80 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

80 subjects in total are recruited to this study: 40 subjects in the non-surgical treatment (NST), of which 20 participants in the NST Study group (NST-1) and 20 participants in the NST Control group (NST-2), and 40 subjects in the surgical treatment (ST), of which 20 participants in the ST Study group (ST-1) and 20 participants in the ST Control group (ST-2).80 subjects in total are recruited to this study: 40 subjects in the non-surgical treatment (NST), of which 20 participants in the NST Study group (NST-1) and 20 participants in the NST Control group (NST-2), and 40 subjects in the surgical treatment (ST), of which 20 participants in the ST Study group (ST-1) and 20 participants in the ST Control group (ST-2).

Masking:

Double (Participant, Investigator)

Masking Description:

The first assessments will be made before randomization. After the randomization, there is no masking.

Primary Purpose:

Treatment

Official Title:

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

Anticipated Study Start Date :

Oct 1, 2023

Anticipated Primary Completion Date :

Mar 31, 2025

Anticipated Study Completion Date :

Dec 31, 2026

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Non-surgical treatment, Study group (NST-1) 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.	Device: Lumoral Treatment Anti-infective photodynamic therapy for plaque-induced oral conditions Procedure: Standard oral hygiene instructions Standard oral hygiene instructions for electric toothbrushing, interdental brush, and dental floss use Procedure: Scaling and root planing (SRP non-surgical anti-infective treatment by scaling and root planing
Active Comparator: Non-surgical treatment, Control group (NST-2) 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.	Procedure: Standard oral hygiene instructions Standard oral hygiene instructions for electric toothbrushing, interdental brush, and dental floss use Procedure: Scaling and root planing (SRP non-surgical anti-infective treatment by scaling and root planing
Experimental: Surgical treatment, Study group (ST-1) Lumoral Treatment; Surgical anti-infective peri-implantitis treatment; and Standard oral hygiene instructions for electric toothbrushing, interdental brush, and dental floss use.	Device: Lumoral Treatment Anti-infective photodynamic therapy for plaque-induced oral conditions Procedure: Standard oral hygiene instructions Standard oral hygiene instructions for electric toothbrushing, interdental brush, and dental floss use Procedure: surgical anti-infective peri-implantitis treatment surgical anti-infective peri-implantitis treatment
Active Comparator: Surgical treatment, Control group (ST-2) Surgical anti-infective peri-implantitis treatment; and Standard oral hygiene instructions for electric toothbrushing, interdental brush, and dental floss use.	Procedure: Standard oral hygiene instructions Standard oral hygiene instructions for electric toothbrushing, interdental brush, and dental floss use Procedure: surgical anti-infective peri-implantitis treatment surgical anti-infective peri-implantitis treatment

Outcome Measures

Primary Outcome Measures

Bleeding on probing (BOP) [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 Outcome Measures

Active matrix metalloproteinase 8 (aMMP-8) [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.
Inflammatory marker total MMP-8 analysis [6 months]
Measurement of pro and active MMP-8. Units: ng/ml.
Inflammatory marker total MMP-9 analysis [6 months]
Measurement of pro and active MMP-9. Units: ng/ml.
Inflammatory marker total MMP-2 analysis [6 months]
Measurement of pro and active MMP-2. Units: ng/ml.
Inflammatory marker total TIMP analysis [6 months]
Units: ng/ml.
Interleukins analysis [6 months]
Units: pg/ml.
Total calprotectin analysis [6 months]
Salivary calprotectin. Units: microgram/ml.
Peridontal Pocket Depth (PPD) [6 months]
A full-mouth assessment, measured at six sites per tooth. Assessed from the base of the pocket to the gingival margin (mm)
Visual Plaque Index( VPI) [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
Clinical Attachment Level (CAL) [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
Bacterial flora [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
Adverse events [6 months]
Any suspicion of an adverse event related to the investigational device, the treatment method, or the study protocol.
OHIP-14 questionnaire [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 Outcome Measures

Mobility assessment [6 months]
Manual assessment of the template movement, mobility testing sideways, and up and down - Scoring in numbers 0 - 3
Suppuration index [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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 85 Years

Sexes Eligible for Study:

All

Accepts 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