Prevention of Dental Implant Diseases

Peri-Implantitis Clinical Trial

Official title:

Prevention of Dental Implant Diseases: Early Diagnosis and Monitoring in Clinical Work and Enhanced Oral Health Maintenance at Home

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05871229
• Other study ID #: IS-TRE
• Status: Completed
• Phase: N/A
• Start date: January 13, 2023
• Est. completion date: July 14, 2023

Study information

• Verified date: August 2023
• Source: Koite Health Oy
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

The hypothesis is that antibacterial photodynamic therapy improves tissue health by reducing inflammation without any side effect.

Study participants will be invited from a dental clinic in Tampere, Finland, from the patients of an oral hygienist's office. Participants will be randomized to the treatment and control groups using the closed envelope method. Participants in the treatment group will receive Lumoral® treatment according to the manufacturer's protocol, once daily for 10 min for 15 days and then twice daily for 15 days.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: July 14, 2023
• Est. primary completion date: July 14, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 25 Years and older

Eligibility

Inclusion Criteria:

• One or more dental implants

• Diagnosis of peri-implantitis

• Challenges in keeping high self-care oral care standards

• Over 25 years of age

Exclusion Criteria:

• Any antibiotic medication within 6 months prior to study participation

Related Conditions & MeSH terms

• Peri-Implantitis

Intervention

Device:
• Lumoral Treatment
Photodynamic antibacterial dual-light device with a marker substance

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

Locations

Country	Name	City	State
Finland	Hammasklinikka Kruunu Oy	Tampere	Pirkanmaa

Sponsors (4)

Lead Sponsor	Collaborator
Hanna Lähteenmäki	Hammasklinikka Kruunu, Koite Health Oy, University of Helsinki

Country where clinical trial is conducted

Finland, 

References & 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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

* Note: There are 12 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Active matrix metalloproteinase 8 (aMMP-8)	Change in periodontal inflammation marker aMMP-8	30 days
Secondary	Bleeding on probing (BOP)	Improvement in bleeding on probing (BOP); A full-mouth assessment at six sites per tooth (mesiobuccal, buccal, distobuccal, mesiolingual, lingual, distolingual) 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 is reported as the percentage (%) of sites with positive findings Calculation formula: number of bleeding sites/ 6 times number of teeth	30 days
Secondary	Visible plaque index (VPI)	Change in visible plaque index	30 days

External Links

•   Alassiri, S. et al. (2018). The Ability of Quantitative, Specific, and Sensitive Point-of-Care/Chair-Side Oral Fluid Immunotests for aMMP-8 to Detect Periodontal and Peri-Implant Diseases. Disease Markers
•   Emingil, G. et al. (2019). Adjunctive effects of a sub-antimicrobial dose of doxycycline on clinical parameters and potential biomarkers of periodontal tissue catabolism. Dentistry Journal, 7(1)
•   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
•   Lähteenmäki, H. et al. Repeated Home-Applied Dual-Light Antibacterial Photodynamic Therapy Can Reduce Plaque Burden, Inflammation, and aMMP-8 in Peri-Implant Disease-A Pilot Study. Current Issues in Molecular Biology 2022, Vol. 44, Pages 1273-1283.
•   Monje, A., Insua, A., & Wang, H.-L. (2019). Understanding Peri-Implantitis as a Plaque-Associated and Site-Specific Entity: On the Local Predisposing Factors. Journal of Clinical Medicine, 8(2), 279.
•   Nikinmaa, S. et al. (2021) Daily administered dual-light photodynamic therapy provides a sustained antibacterial effect on staphylococcus aureus. Antibiotics, 10(10).
•   Nikinmaa, S. et al. (2021) Indocyanine green-assisted and led-light-activated antibacterial photodynamic therapy reduces dental plaque. Dentistry Journal, 9(5).
•   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).
•   Sahrmann, P., Gilli, F., Wiedemeier, D. B., Attin, T., Schmidlin, P. R., & Karygianni, L. (2020). The Microbiome of Peri-Implantitis: A Systematic Review and Meta-Analysis. Microorganisms (Basel), 8(5), 661