Peri-Implant HealthIMP_TRENCT06761521
Monitoring of Implant Diseases: Diagnosis and Monitoring With aMMP-8 Test Technology
A study testing Peri-Implantitis and Peri-implant mucositis in people with Peri-Implant Health and Peri-Implantitis and Peri-implant Mucositis, run by Hanna Lahteenmaki at 1 site in Finland.
Trial summary
68 patients underwent the aMMP-8 chair-side test as well as clinical traditional measurement methods. Those who had one or more implants in their mouth were selected as patients. The condition of the attachment tissues of these implants is monitored at a control visit after five years. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Peri-Implant Health, Peri-Implantitis and Peri-implant Mucositis
- What is being tested?
- Peri-Implantitis and Peri-implant mucositis
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteFinland
- Study dates
- 11 Jan 2025to 20 Nov 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- the participation previously study implant patient
Who cannot join
- has not received antibiotic treatment within 6 months
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Finland1 site
Department of Oral and Maxillofacial Diseases, Head and Neck Center
Helsinki, Uusimaa, FI-00014
About this study
Official title: Monitoring of Implant Diseases: Diagnosis and Monitoring With aMMP-8 Test Technology: A 5-year Follow-up Study
68 patients underwent the aMMP-8 chair-side test as well as clinical traditional measurement methods. Those who had one or more implants in their mouth were selected as patients. The condition of the attachment tissues of these implants is monitored at a control visit after five years.
Read the detailed description
Patients who arrive for maintenance follow-up are included in the study. The trational measurement technique is used to follow the health of peri-implant tissues.
- Being tested
- Peri-Implantitis and Peri-implant mucositis
- Keywords
- Ammp-8, Peri-implant diseases, mucositis, prevention, maintenance
- Medical subject headings
- Peri-Implantitis, Mucositis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Peri-Implantitis and Peri-implant mucositisDiagnostic test
peri-implant mucositis, peri-implantitis
| Study group | Role | What they receive |
|---|---|---|
| patients who had participated in a previous study | Other | Bleeding on probing, Peri-implant pocket depth, x-ray findings and aMMP-8 tests will be taking. Receives: Diagnostic Test: Peri-Implantitis and Peri-implant mucositis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tratitional measurement
the depth of the implant's gum pocket
Measured: 5 years
Traditional measure
Bleedin on probing
Measured: through study completion, an average of 5 year
Biomarker test
aMMP-8 tests, taking peri-implant sulcus fluid
Measured: through study completion, an average of 5 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2025
- Study start11 Jan 2025
- Primary completion11 Sep 2025 (estimated)
- Study completion20 Nov 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Peri-Implant HealthStudies 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
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hanna Lahteenmaki
- Sponsor type
- University, hospital or other
- Collaborators
- University of Helsinki
- Responsible party
- Sponsor-investigator, Hanna Lahteenmaki, Lahanna oy
- Investigators
- Timo Sorsa, Professor, Study director, University of Helsinki
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06761521
- Sponsor's protocol ID
- 20092024
- Acronym
- IMP_TRE
- Status last verified
- Mar 2025
- First submitted
- 25 Sep 2024
- Last updated
- 6 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Lahteenmaki H, Umeizudike KA, Heikkinen AM, Raisanen IT, Rathnayake N, Johannsen G, Tervahartiala T, Nwhator SO, Sorsa T. aMMP-8 Point-of-Care/Chairside Oral Fluid Technology as a Rapid, Non-Invasive Tool for Periodontitis and Peri-Implantitis Screening in a Medical Care Setting. Diagnostics (Basel). 2020 Aug 5;10(8):562. doi: 10.3390/diagnostics10080562.
PubMed 32764436Natto ZS, Almeganni N, Alnakeeb E, Bukhari Z, Jan R, Iacono VJ. Peri-Implantitis and Peri-Implant Mucositis Case Definitions in Dental Research: A Systematic Assessment. J Oral Implantol. 2019 Apr;45(2):127-131. doi: 10.1563/aaid-joi-D-18-00097. Epub 2018 Dec 17.
PubMed 30557088Sorsa T, Tervahartiala T, Leppilahti J, Hernandez M, Gamonal J, Tuomainen AM, Lauhio A, Pussinen PJ, Mantyla P. Collagenase-2 (MMP-8) as a point-of-care biomarker in periodontitis and cardiovascular diseases. Therapeutic response to non-antimicrobial properties of tetracyclines. Pharmacol Res. 2011 Feb;63(2):108-13. doi: 10.1016/j.phrs.2010.10.005. Epub 2010 Oct 16.
PubMed 20937384Tonetti MS, Greenwell H, Kornman KS. Staging and grading of periodontitis: Framework and proposal of a new classification and case definition. J Periodontol. 2018 Jun;89 Suppl 1:S159-S172. doi: 10.1002/JPER.18-0006.
PubMed 29926952
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Monitoring of Implant Diseases: Diagnosis and Monitoring With aMMP-8 Test Technology: A 5-year Follow-up Study
- ClinicalTrials.gov ID
- NCT06761521
- Acronym / sponsor ID
- IMP_TRE / 20092024
- Keywords
- Ammp-8, Peri-implant diseases, mucositis, prevention, maintenance
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Hanna LahteenmakiUniversity, hospital or other
- Collaborators
- University of Helsinki
- Study start
- 11 Jan 2025 (actual)
- Primary completion
- 11 Sep 2025 (estimated)
- Study completion
- 20 Nov 2025 (estimated)
- First posted
- 7 Jan 2025 (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.
68 patients underwent the aMMP-8 chair-side test as well as clinical traditional measurement methods. Those who had one or more implants in their mouth were selected as patients. The condition of the attachment tissues of these implants is monitored at a control visit after five years.
Detailed description
Patients who arrive for maintenance follow-up are included in the study. The trational measurement technique is used to follow the health of peri-implant tissues.
Study design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| patients who had participated in a previous study | Other | Diagnostic Test: Peri-Implantitis and Peri-implant mucositisBleeding on probing, Peri-implant pocket depth, x-ray findings and aMMP-8 tests will be taking. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- the participation previously study implant patient
Key exclusion criteria (1 listed)
- has not received antibiotic treatment within 6 months
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 |
|---|---|---|
| Peri-Implantitis and Peri-implant mucositisperi-implant mucositis, peri-implantitis | Diagnostic test | patients who had participated in a previous study |
Primary outcome
Tratitional measurement
Time frame: 5 years
the depth of the implant's gum pocket
Traditional measure
Time frame: through study completion, an average of 5 year
Bleedin on probing
Biomarker test
Time frame: through study completion, an average of 5 year
aMMP-8 tests, taking peri-implant sulcus fluid
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2025.
- Results publication: PubMed 32764436Lahteenmaki H, Umeizudike KA, Heikkinen AM, Raisanen IT, Rathnayake N, Johannsen G, Tervahartiala T, Nwhator SO, Sorsa T. aMMP-8 Point-of-Care/Chairside Oral Fluid Technology as a Rapid, Non-Invasive Tool for Periodontitis and Peri-Implantitis Screening in a Medical Care Setting. Diagnostics (Basel). 2020 Aug 5;10(8):562. doi: 10.3390/diagnostics10080562.
- Results publication: PubMed 30557088Natto ZS, Almeganni N, Alnakeeb E, Bukhari Z, Jan R, Iacono VJ. Peri-Implantitis and Peri-Implant Mucositis Case Definitions in Dental Research: A Systematic Assessment. J Oral Implantol. 2019 Apr;45(2):127-131. doi: 10.1563/aaid-joi-D-18-00097. Epub 2018 Dec 17.
- Results publication: PubMed 20937384Sorsa T, Tervahartiala T, Leppilahti J, Hernandez M, Gamonal J, Tuomainen AM, Lauhio A, Pussinen PJ, Mantyla P. Collagenase-2 (MMP-8) as a point-of-care biomarker in periodontitis and cardiovascular diseases. Therapeutic response to non-antimicrobial properties of tetracyclines. Pharmacol Res. 2011 Feb;63(2):108-13. doi: 10.1016/j.phrs.2010.10.005. Epub 2010 Oct 16.
- Results publication: PubMed 29926952Tonetti MS, Greenwell H, Kornman KS. Staging and grading of periodontitis: Framework and proposal of a new classification and case definition. J Periodontol. 2018 Jun;89 Suppl 1:S159-S172. doi: 10.1002/JPER.18-0006.
- 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.
Timo Sorsa, Professor study director
University of Helsinki
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Peri-Implantitis and Peri-implant mucositis in people with Peri-Implant Health and Peri-Implantitis and Peri-implant Mucositis, run by Hanna Lahteenmaki 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 1 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: enrolling by invitation, as of the sponsor's last update on 6 Mar 2025. 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?
This study is still under way. Results are not available in the source record yet.
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?
Tratitional measurement (time frame: 5 years). The study lists 3 primary outcomes in all. 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 NCT06761521, which also lists 4 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 6 Mar 2025.