Antibacterial Photodynamic Therapy in the Management of Peri-implantitis

NCT06017817 | Recruiting

• 1 other identifier: HEALTHIER
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Peri-Implantitis; Plaque, Dental

Keywords

Lumoral; Lumorinse; Antibacterial photodynamic therapy (aBPT); aMMP-8; Plaque control

Outcome Measures

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

  6 months

Secondary Outcomes (13)

• Active matrix metalloproteinase 8 (aMMP-8)

  6 months

• Inflammatory marker total MMP-8 analysis

  6 months

• Inflammatory marker total MMP-9 analysis

  6 months

• Inflammatory marker total MMP-2 analysis

  6 months

• Inflammatory marker total TIMP analysis

  6 months

Other Outcomes (2)

• Mobility assessment

  6 months

• Suppuration index

  6 months

Study Arms (4)

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

EXPERIMENTAL

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; Procedure: Standard oral hygiene instructions; Procedure: Scaling and root planing (SRP

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

ACTIVE COMPARATOR

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; Procedure: Scaling and root planing (SRP

Surgical treatment, Study group (ST-1)

EXPERIMENTAL

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; Procedure: Standard oral hygiene instructions; Procedure: surgical anti-infective peri-implantitis treatment

Surgical treatment, Control group (ST-2)

ACTIVE COMPARATOR

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; Procedure: surgical anti-infective peri-implantitis treatment

Interventions

Lumoral Treatment DEVICE

Anti-infective photodynamic therapy for plaque-induced oral conditions

Non-surgical treatment, Study group (NST-1); Surgical treatment, Study group (ST-1)

Standard oral hygiene instructions PROCEDURE

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

Non-surgical treatment, Control group (NST-2); Non-surgical treatment, Study group (NST-1); Surgical treatment, Control group (ST-2); Surgical treatment, Study group (ST-1)

Scaling and root planing (SRP PROCEDURE

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

Non-surgical treatment, Control group (NST-2); Non-surgical treatment, Study group (NST-1)

surgical anti-infective peri-implantitis treatment PROCEDURE

surgical anti-infective peri-implantitis treatment

Surgical treatment, Control group (ST-2); Surgical treatment, Study group (ST-1)

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Nilminie Rathnayake: lead
• University of Helsinki: collaborator

Study Sites (1)

Södertandläkarna AB

Stockholm, 11622, Sweden

RECRUITING

Related Publications (8)

• Berglundh T, Jepsen S, Stadlinger B, Terheyden H. Peri-implantitis and its prevention. Clin Oral Implants Res. 2019 Feb;30(2):150-155. doi: 10.1111/clr.13401. Epub 2019 Feb 3.

  PMID: 30636066 BACKGROUND

• Jepsen S, Berglundh T, Genco R, Aass AM, Demirel K, Derks J, Figuero E, Giovannoli JL, Goldstein M, Lambert F, Ortiz-Vigon A, Polyzois I, Salvi GE, Schwarz F, Serino G, Tomasi C, Zitzmann NU. Primary prevention of peri-implantitis: managing peri-implant mucositis. J Clin Periodontol. 2015 Apr;42 Suppl 16:S152-7. doi: 10.1111/jcpe.12369.

  PMID: 25626479 BACKGROUND

• Kassebaum NJ, Bernabe E, Dahiya M, Bhandari B, Murray CJ, Marcenes W. Global burden of severe periodontitis in 1990-2010: a systematic review and meta-regression. J Dent Res. 2014 Nov;93(11):1045-53. doi: 10.1177/0022034514552491. Epub 2014 Sep 26.

  PMID: 25261053 BACKGROUND

• Kassebaum NJ, Smith AGC, Bernabe E, Fleming TD, Reynolds AE, Vos T, Murray CJL, Marcenes W; GBD 2015 Oral Health Collaborators. Global, Regional, and National Prevalence, Incidence, and Disability-Adjusted Life Years for Oral Conditions for 195 Countries, 1990-2015: A Systematic Analysis for the Global Burden of Diseases, Injuries, and Risk Factors. J Dent Res. 2017 Apr;96(4):380-387. doi: 10.1177/0022034517693566.

  PMID: 28792274 BACKGROUND

• Lang NP, Suvan JE, Tonetti MS. Risk factor assessment tools for the prevention of periodontitis progression a systematic review. J Clin Periodontol. 2015 Apr;42 Suppl 16:S59-70. doi: 10.1111/jcpe.12350.

  PMID: 25496279 BACKGROUND

• Lahteenmaki H, Patila T, Raisanen IT, Kankuri E, Tervahartiala T, Sorsa T. Repeated Home-Applied Dual-Light Antibacterial Photodynamic Therapy Can Reduce Plaque Burden, Inflammation, and aMMP-8 in Peri-Implant Disease-A Pilot Study. Curr Issues Mol Biol. 2022 Mar 8;44(3):1273-1283. doi: 10.3390/cimb44030085.

  PMID: 35723308 BACKGROUND

• Nikinmaa S, Moilanen N, Sorsa T, Rantala J, Alapulli H, Kotiranta A, Auvinen P, Kankuri E, Meurman JH, Patila T. Indocyanine Green-Assisted and LED-Light-Activated Antibacterial Photodynamic Therapy Reduces Dental Plaque. Dent J (Basel). 2021 May 3;9(5):52. doi: 10.3390/dj9050052.

  PMID: 34063662 BACKGROUND

• Slade GD. Derivation and validation of a short-form oral health impact profile. Community Dent Oral Epidemiol. 1997 Aug;25(4):284-90. doi: 10.1111/j.1600-0528.1997.tb00941.x.

  PMID: 9332805 BACKGROUND

Related Links

• Alaijah, F., Morsi, A., Nasher, R. et al. Photobiomodulation therapy in the treatment of periodontal disease: a literature review. Laser Dent Sci 3, 147-153 (2019)
• Gomes SC, Romagna R, Rossi V, Corvello PC, Melchiors-Angst PD. Supragingival treatment as an aid to reduce subgingival needs: a 450-day investigation Braz. oral res. 28 (1) 2014
• Levine JI. Medications that increase photosensitivity. FDA document Dec 1990.
• Nikinmaa S, Alapulli H, Auvinen P, et al. (2020) Dual-light photodynamic therapy administered daily provides a sustained antibacterial effect on biofilm and prevents Streptococcus mutans adaptation. PLoS ONE 15(5)
• Pereira PAB, Aho VTE, Paulin L, et al., (2017) Oral and nasal microbiota in Parkinson's disease. Parkinsonism and Related Disorders 38: 61-67

MeSH Terms

Conditions

Peri-Implantitis; Dental Plaque

Interventions

Tooth Exfoliation; Root Planing

Condition Hierarchy (Ancestors)

Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Dental Deposits; Tooth Diseases

Intervention Hierarchy (Ancestors)

Dental Physiological Phenomena; Digestive System and Oral Physiological Phenomena; Dental Scaling; Dental Prophylaxis; Periodontics; Dentistry; Subgingival Curettage; Preventive Dentistry

Study Officials

• Nilminie Rathnayake, Assoc Prof

  University of Helsinki

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mikko Kylmänen

CONTACT

+358407245934; mikko.kylmanen@koitehealth.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: The first assessments will be made before randomization. After the randomization, there is no masking.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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).

Study Record Dates

• First Submitted: August 24, 2023
• First Posted: August 30, 2023
• Study Start: May 13, 2024
• Primary Completion: March 31, 2025
• Study Completion (Estimated): December 31, 2026
• Last Updated: October 18, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)