Prevention of Dental Implant Diseases

NCT05871229 | Completed

• 1 other identifier: IS-TRE
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study is to determine the effect of regular antibacterial photodynamic Lumoral® treatment on gingival health and plaque volume, and anti-inflammatory effect of daily double light therapy on implant teeth. The study will use a medical device containing a light-activated Lumorinse® mouthwash and a Lumoral® light activator.

Conditions

Peri-Implantitis

Keywords

Peri-implant disease; aMMP-8; Antibacterial photodynamic therapy (aBPT); Oral hygiene

Outcome Measures

Primary Outcomes (1)

• Active matrix metalloproteinase 8 (aMMP-8)

  Change in periodontal inflammation marker aMMP-8

  30 days

Secondary Outcomes (2)

• Bleeding on probing (BOP)

  30 days

• Visible plaque index (VPI)

  30 days

Study Arms (2)

Study group

EXPERIMENTAL

Lumoral and standard treatment

Device: Lumoral Treatment; Other: Standard treatment for peri-implantitis

Control group

OTHER

Standard treatment only

Other: Standard treatment for peri-implantitis

Interventions

Lumoral Treatment DEVICE

Photodynamic antibacterial dual-light device with a marker substance

Study group

Standard treatment for peri-implantitis OTHER

Standard treatment for peri-implantitis as per international, national and clinic guidelines

Control group; Study group

Eligibility Criteria

• Age: 25 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• One or more dental implants
• Diagnosis of peri-implantitis
• Challenges in keeping high self-care oral care standards
• Over 25 years of age

You may not qualify if:

• \- Any antibiotic medication within 6 months prior to study participation

Sponsors & Collaborators

• Hanna Lähteenmäki: lead
• University of Helsinki: collaborator
• Koite Health Oy: collaborator
• Hammasklinikka Kruunu: collaborator

Study Sites (1)

Hammasklinikka Kruunu Oy

Tampere, Pirkanmaa, 33200, Finland

Location

Related Publications (12)

• Dhir S, Mahesh L, Kurtzman GM, Vandana KL. Peri-implant and periodontal tissues: a review of differences and similarities. Compend Contin Educ Dent. 2013 Jul-Aug;34(7):e69-75.

  PMID: 24428439 BACKGROUND

• Matsubara T, Kusuzaki K, Matsumine A, Satonaka H, Shintani K, Nakamura T, Uchida A. Methylene blue in place of acridine orange as a photosensitizer in photodynamic therapy of osteosarcoma. In Vivo. 2008 May-Jun;22(3):297-303.

  PMID: 18610739 BACKGROUND

• Raisanen IT, Heikkinen AM, Nwhator SO, Umeizudike KA, Tervahartiala T, Sorsa T. On the diagnostic discrimination ability of mouthrinse and salivary aMMP-8 point-of-care testing regarding periodontal health and disease. Diagn Microbiol Infect Dis. 2019 Dec;95(4):114871. doi: 10.1016/j.diagmicrobio.2019.114871. Epub 2019 Jul 26.

  PMID: 31473032 BACKGROUND

• Salvi GE, Zitzmann NU. The effects of anti-infective preventive measures on the occurrence of biologic implant complications and implant loss: a systematic review. Int J Oral Maxillofac Implants. 2014;29 Suppl:292-307. doi: 10.11607/jomi.2014suppl.g5.1.

  PMID: 24660205 BACKGROUND

• Schwarz F, Becker K, Sager M. Efficacy of professionally administered plaque removal with or without adjunctive measures for the treatment of peri-implant mucositis. A systematic review and meta-analysis. J Clin Periodontol. 2015 Apr;42 Suppl 16:S202-13. doi: 10.1111/jcpe.12349.

  PMID: 25496187 BACKGROUND

• Shinwari MS, Tanwir F, Hyder PR, Bin Saeed MH. Host modulation therapeutics in periodontics: role as an adjunctive periodontal therapy. J Coll Physicians Surg Pak. 2014 Sep;24(9):676-84.

  PMID: 25233975 BACKGROUND

• Smeets R, Henningsen A, Jung O, Heiland M, Hammacher C, Stein JM. Definition, etiology, prevention and treatment of peri-implantitis--a review. Head Face Med. 2014 Sep 3;10:34. doi: 10.1186/1746-160X-10-34.

  PMID: 25185675 BACKGROUND

• Sorsa T, Gieselmann D, Arweiler NB, Hernandez M. A quantitative point-of-care test for periodontal and dental peri-implant diseases. Nat Rev Dis Primers. 2017 Sep 14;3:17069. doi: 10.1038/nrdp.2017.69. No abstract available.

  PMID: 28905941 BACKGROUND

• Sorsa T, Hernandez M, Leppilahti J, Munjal S, Netuschil L, Mantyla P. Detection of gingival crevicular fluid MMP-8 levels with different laboratory and chair-side methods. Oral Dis. 2010 Jan;16(1):39-45. doi: 10.1111/j.1601-0825.2009.01603.x. Epub 2009 Jul 8.

  PMID: 19627514 BACKGROUND

• Sorsa T, Tjaderhane L, Salo T. Matrix metalloproteinases (MMPs) in oral diseases. Oral Dis. 2004 Nov;10(6):311-8. doi: 10.1111/j.1601-0825.2004.01038.x.

  PMID: 15533204 BACKGROUND

• Suarez-Lopez Del Amo F, Yu SH, Wang HL. Non-Surgical Therapy for Peri-Implant Diseases: a Systematic Review. J Oral Maxillofac Res. 2016 Sep 9;7(3):e13. doi: 10.5037/jomr.2016.7313. eCollection 2016 Jul-Sep.

  PMID: 27833738 BACKGROUND

• Terheyden H, Stadlinger B, Sanz M, Garbe AI, Meyle J. Inflammatory reaction - communication of cells. Clin Oral Implants Res. 2014 Apr;25(4):399-407. doi: 10.1111/clr.12176. Epub 2013 Apr 21.

  PMID: 23600659 BACKGROUND

Related Links

• Hentilä, J. et al. (2021). Dual-Light Photodynamic Therapy Effectively Eliminates Streptococcus Oralis Biofilms. Journal of Pharmacy \& Pharmaceutical Sciences, 24
• Kilian, M. et al. (2016). The oral microbiome - An update for oral healthcare professionals. British Dental Journal, 221(10).
• Kormi, I et al. (2014) The effect of prolonged systemic doxycycline therapy on serum tissue degrading proteinases in coronary bypass patients: a randomized, double-masked, placebo-controlled clinical trial. Inflammation Research, 63(5), 329-334
• Nikinmaa, S., 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).

MeSH Terms

Conditions

Peri-Implantitis

Condition Hierarchy (Ancestors)

Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

Study Officials

• Hanna Lähteenmäki, Doctor

  Hammasklinikka Kruunu

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Participants will be randomized at the end of baseline visit
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: PhD, Dental Hygienist

Model Details: Randomized

Study Record Dates

• First Submitted: May 3, 2023
• First Posted: May 23, 2023
• Study Start: January 13, 2023
• Primary Completion: July 14, 2023
• Study Completion: July 14, 2023
• Last Updated: August 9, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

FI (1)