Peri-implant MucositisNCT06408467
Monitoring of Non-Surgical Treatment of Peri-implantitis
A study testing aMMP-8 diagnostic test in people with Peri-implant Mucositis and Peri-Implantitis, run by Lahanna oy at 1 site in Finland.
Trial summary
This study aimed to investigate the response to non-surgical treatment of peri-implantitis diseases during the maintenance phase. The patients underwent non-surgical implant maintenance treatment, and the success of the treatment was measured again after 30 days using the same criteria and methods. Read more about this study
- Who is it for?
- Ages 25 years and olderHealthy volunteers can take part
- Conditions the study is for
- Peri-implant Mucositis, Peri-Implantitis
- What is being tested?
- aMMP-8 diagnostic test
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteFinland
- Study dates
- 1 Jan 2022to 15 Nov 2022
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- implant patients arriving for a maintenance visit at a dental clinic
- a diagnosis of peri-implant healthy, peri-implant mucositis, or peri-implantitis by a dentist
- a written informed consent.
Who cannot join
- Smoking
- age under 25
- antibiotic treatment within six months
- the maintenance treatment had been completed within 6 months.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Monitoring of Non-Surgical Treatment of Peri-implantitis, Traditional Measurement Methods and aMMP-8 Test Technology-Cross Sectional Study
This study aimed to investigate the response to non-surgical treatment of peri-implantitis diseases during the maintenance phase. The patients underwent non-surgical implant maintenance treatment, and the success of the treatment was measured again after 30 days using the same criteria and methods.
Read the detailed description
For 40 patients, the aMMP-8 test was performed on the buccal gingival pocket of the implant teeth, gingival bleeding (BOP), implant pocket depth (PPD), and a periapical x-ray to measure radiologic bone level (RBL) were taken.
- Conditions
- Peri-implant Mucositis, Peri-Implantitis
- Being tested
- aMMP-8 diagnostic test
- Keywords
- peri-implant treatment, aMMP-8, non-surgical treatment
- Medical subject headings
- Peri-Implantitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
aMMP-8 diagnostic testOther
40 patients
| Study group | Role | What they receive |
|---|---|---|
| The effect and monitoring of maintenance therapy for peri-implantitis | Experimental | Not described Receives: Other: aMMP-8 diagnostic test |
What is being measured
The primary outcome is the main question the study is designed to answer.
the result of the participants who were measured aMMP-8
Measure aMMP-8-level ng/ml
Measured: 1 month
the result of the participants who were measured BOP
measure bleeding on probing in PISF
Measured: 1 month
the result of the participants who were measured PPD
measure peri-implant pocket depth
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 May 2024
- Study start1 Jan 2022
- Primary completion1 Jul 2022
- Study completion15 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Peri-implant MucositisStudies 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
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lahanna oy
- Sponsor type
- University, hospital or other
- Collaborators
- University of Helsinki
- Responsible party
- Sponsor
- Investigators
- Timo Sorsa, Professor, Study director, University of Helsinki
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06408467
- Sponsor's protocol ID
- Lahanna
- Status last verified
- May 2024
- First submitted
- 2 May 2024
- Last updated
- 10 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: There is a plan to make IPD and related data dictionaries available after the research
Publications
Lindhe J, Meyle J; Group D of European Workshop on Periodontology. Peri-implant diseases: Consensus Report of the Sixth European Workshop on Periodontology. J Clin Periodontol. 2008 Sep;35(8 Suppl):282-5. doi: 10.1111/j.1600-051X.2008.01283.x.
PubMed 18724855Figuero E, Graziani F, Sanz I, Herrera D, Sanz M. Management of peri-implant mucositis and peri-implantitis. Periodontol 2000. 2014 Oct;66(1):255-73. doi: 10.1111/prd.12049.
PubMed 25123773Lahteenmaki 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 32764436Alassy H, Parachuru P, Wolff L. Peri-Implantitis Diagnosis and Prognosis Using Biomarkers in Peri-Implant Crevicular Fluid: A Narrative Review. Diagnostics (Basel). 2019 Dec 7;9(4):214. doi: 10.3390/diagnostics9040214.
PubMed 31817894Lahteenmaki H, Raisanen IT, Tervahartiala T, Parnanen P, Patila T, Sorsa T. Monitoring of Nonsurgical Treatment of Peri-Implantitis Traditional Measurement Methods and aMMP-8 Test Technology: A Pilot Study. Int J Dent. 2025 Nov 27;2025:6681032. doi: 10.1155/ijod/6681032. eCollection 2025.
PubMed 41358008
Study at a glance
From the registry record, last updated by the sponsor on 10 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Monitoring of Non-Surgical Treatment of Peri-implantitis, Traditional Measurement Methods and aMMP-8 Test Technology-Cross Sectional Study
- ClinicalTrials.gov ID
- NCT06408467
- Acronym / sponsor ID
- Lahanna
- Conditions
- Peri-implant Mucositis, Peri-Implantitis
- Keywords
- peri-implant treatment, aMMP-8, non-surgical treatment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Lahanna oyUniversity, hospital or other
- Collaborators
- University of Helsinki
- Study start
- 1 Jan 2022 (actual)
- Primary completion
- 1 Jul 2022 (actual)
- Study completion
- 15 Nov 2022 (actual)
- First posted
- 10 May 2024 (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.
This study aimed to investigate the response to non-surgical treatment of peri-implantitis diseases during the maintenance phase. The patients underwent non-surgical implant maintenance treatment, and the success of the treatment was measured again after 30 days using the same criteria and methods.
Detailed description
For 40 patients, the aMMP-8 test was performed on the buccal gingival pocket of the implant teeth, gingival bleeding (BOP), implant pocket depth (PPD), and a periapical x-ray to measure radiologic bone level (RBL) were taken.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| The effect and monitoring of maintenance therapy for peri-implantitis | Experimental | Other: aMMP-8 diagnostic test |
Who may qualify
- Ages
- 25 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- implant patients arriving for a maintenance visit at a dental clinic
- a diagnosis of peri-implant healthy, peri-implant mucositis, or peri-implantitis by a dentist
- a written informed consent.
Key exclusion criteria (4 listed)
- Smoking
- age under 25
- antibiotic treatment within six months
- the maintenance treatment had been completed 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 |
|---|---|---|
| aMMP-8 diagnostic test40 patients | Other | The effect and monitoring of maintenance therapy for peri-implantitis |
Primary outcome
the result of the participants who were measured aMMP-8
Time frame: 1 month
Measure aMMP-8-level ng/ml
the result of the participants who were measured BOP
Time frame: 1 month
measure bleeding on probing in PISF
the result of the participants who were measured PPD
Time frame: 1 month
measure peri-implant pocket depth
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 10 May 2024.
- Results publication: PubMed 18724855Lindhe J, Meyle J; Group D of European Workshop on Periodontology. Peri-implant diseases: Consensus Report of the Sixth European Workshop on Periodontology. J Clin Periodontol. 2008 Sep;35(8 Suppl):282-5. doi: 10.1111/j.1600-051X.2008.01283.x.
- Results publication: PubMed 25123773Figuero E, Graziani F, Sanz I, Herrera D, Sanz M. Management of peri-implant mucositis and peri-implantitis. Periodontol 2000. 2014 Oct;66(1):255-73. doi: 10.1111/prd.12049.
- 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 31817894Alassy H, Parachuru P, Wolff L. Peri-Implantitis Diagnosis and Prognosis Using Biomarkers in Peri-Implant Crevicular Fluid: A Narrative Review. Diagnostics (Basel). 2019 Dec 7;9(4):214. doi: 10.3390/diagnostics9040214.
- Derived from this study: PubMed 41358008Lahteenmaki H, Raisanen IT, Tervahartiala T, Parnanen P, Patila T, Sorsa T. Monitoring of Nonsurgical Treatment of Peri-Implantitis Traditional Measurement Methods and aMMP-8 Test Technology: A Pilot Study. Int J Dent. 2025 Nov 27;2025:6681032. doi: 10.1155/ijod/6681032. eCollection 2025.
- Individual participant dataSharing planned: Yes. There is a plan to make IPD and related data dictionaries available after the research
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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.
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 aMMP-8 diagnostic test in people with Peri-implant Mucositis and Peri-Implantitis, run by Lahanna oy 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 3 inclusion and 4 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 10 May 2024. 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?
the result of the participants who were measured aMMP-8 (time frame: 1 month). 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 NCT06408467, which also lists 5 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 10 May 2024.