Peri-ImplantitisNCT05871229
Prevention of Dental Implant Diseases
A study testing Lumoral Treatment and Standard treatment for peri-implantitis in people with Peri-Implantitis, run by Hanna Lähteenmäki at 1 site in Finland.
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. Read more about this study
- Who is it for?
- Ages 25 years and older
- Conditions the study is for
- Peri-Implantitis
- What is being tested?
- Lumoral Treatment and Standard treatment for peri-implantitis
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteFinland
- Study dates
- 13 Jan 2023to 14 Jul 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- One or more dental implants
- Diagnosis of peri-implantitis
- Challenges in keeping high self-care oral care standards
- Over 25 years of age
Who cannot join
- Any antibiotic medication within 6 months prior to study participation
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prevention of Dental Implant Diseases: Early Diagnosis and Monitoring in Clinical Work and Enhanced Oral Health Maintenance at Home
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.
Read the detailed 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.
- Conditions
- Peri-Implantitis
- Being tested
- Lumoral Treatment, Standard treatment for peri-implantitis
- Keywords
- Peri-implant disease, aMMP-8, Antibacterial photodynamic therapy (aBPT), Oral hygiene
- Medical subject headings
- Peri-Implantitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lumoral TreatmentDevice
Photodynamic antibacterial dual-light device with a marker substance
Standard treatment for peri-implantitisOther
Standard treatment for peri-implantitis as per international, national and clinic guidelines
| Study group | Role | What they receive |
|---|---|---|
| Study group | Experimental | Lumoral and standard treatment Receives: Device: Lumoral Treatment; Other: Standard treatment for peri-implantitis |
| Control group | Other | Standard treatment only Receives: Other: Standard treatment for peri-implantitis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Active matrix metalloproteinase 8 (aMMP-8)
Change in periodontal inflammation marker aMMP-8
Measured: 30 days
Secondary outcomes (2)
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
Measured: 30 days
Visible plaque index (VPI)
Change in visible plaque index
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2023
- Study start13 Jan 2023
- Primary completion14 Jul 2023
- Study completion14 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for Peri-ImplantitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hanna Lähteenmäki
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- University of Helsinki, Koite Health Oy, Hammasklinikka Kruunu
- Responsible party
- Sponsor-investigator, Hanna Lähteenmäki, Koite Health Oy
- Investigators
- Hanna Lähteenmäki, Doctor, Principal investigator, Hammasklinikka Kruunu
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05871229
- Sponsor's protocol ID
- IS-TRE
- Status last verified
- Aug 2023
- First submitted
- 3 May 2023
- Last updated
- 9 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 24428439Matsubara 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.
PubMed 18610739Raisanen 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.
PubMed 31473032Salvi 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.
PubMed 24660205Schwarz 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.
PubMed 25496187Shinwari 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.
PubMed 25233975Smeets 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.
PubMed 25185675Sorsa 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.
PubMed 28905941Sorsa 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.
PubMed 19627514Sorsa 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.
PubMed 15533204Suarez-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.
PubMed 27833738Terheyden 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.
PubMed 23600659
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevention of Dental Implant Diseases: Early Diagnosis and Monitoring in Clinical Work and Enhanced Oral Health Maintenance at Home
- ClinicalTrials.gov ID
- NCT05871229
- Acronym / sponsor ID
- IS-TRE
- Conditions
- Peri-Implantitis
- Keywords
- Peri-implant disease, aMMP-8, Antibacterial photodynamic therapy (aBPT), Oral hygiene
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Hanna LähteenmäkiIndustry (pharma, biotech, devices)
- Collaborators
- University of Helsinki, Koite Health Oy, Hammasklinikka Kruunu
- Study start
- 13 Jan 2023 (actual)
- Primary completion
- 14 Jul 2023 (actual)
- Study completion
- 14 Jul 2023 (actual)
- First posted
- 23 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- Randomized
| Arm | Type | Receives |
|---|---|---|
| Study group | Experimental | Device: Lumoral Treatment, Other: Standard treatment for peri-implantitisLumoral and standard treatment |
| Control group | Other | Other: Standard treatment for peri-implantitisStandard treatment only |
Who may qualify
- Ages
- 25 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- One or more dental implants
- Diagnosis of peri-implantitis
- Challenges in keeping high self-care oral care standards
- Over 25 years of age
Key exclusion criteria (1 listed)
- Any antibiotic medication within 6 months prior to study participation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lumoral TreatmentPhotodynamic antibacterial dual-light device with a marker substance | Device | Study group |
| Standard treatment for peri-implantitisStandard treatment for peri-implantitis as per international, national and clinic guidelines | Other | Control group, Study group |
Primary outcome
Active matrix metalloproteinase 8 (aMMP-8)
Time frame: 30 days
Change in periodontal inflammation marker aMMP-8
2 secondary outcomes
Bleeding on probing (BOP)
Time frame: 30 days
Visible plaque index (VPI)
Time frame: 30 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Aug 2023.
- Background: PubMed 24428439Dhir 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.
- Background: PubMed 18610739Matsubara 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.
- Background: PubMed 31473032Raisanen 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.
- Background: PubMed 24660205Salvi 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.
- Background: PubMed 25496187Schwarz 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.
- Background: PubMed 25233975Shinwari 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.
- Background: PubMed 25185675Smeets 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.
- Background: PubMed 28905941Sorsa 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.
- Background: PubMed 19627514Sorsa 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.
- Background: PubMed 15533204Sorsa 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.
- Background: PubMed 27833738Suarez-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.
- Background: PubMed 23600659Terheyden 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.
- Berglundh, T., Lindhe, J., Jonsson, K., \& Ericsson, I. (1994). The topography of the vascular systems in the periodontal and peri-implant tissues in the dog. Journal of Clinical Periodontology, 21(3).Link provided by the sponsor.
- Hentilä, J. et al. (2021). Dual-Light Photodynamic Therapy Effectively Eliminates Streptococcus Oralis Biofilms. Journal of Pharmacy \& Pharmaceutical Sciences, 24Link provided by the sponsor.
- Kilian, M. et al. (2016). The oral microbiome - An update for oral healthcare professionals. British Dental Journal, 221(10).Link provided by the sponsor.
- 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), 329-334Link provided by the sponsor.
- 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).Link provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hanna Lähteenmäki, Doctor principal investigator
Hammasklinikka Kruunu
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lumoral Treatment and Standard treatment for peri-implantitis in people with Peri-Implantitis, run by Hanna Lähteenmäki at 1 site in Finland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Finland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Active matrix metalloproteinase 8 (aMMP-8) (time frame: 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05871229, which also lists 12 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Aug 2023.