- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06761521
Monitoring of Implant Diseases: Diagnosis and Monitoring with AMMP-8 Test Technology (IMP_TRE)
March 5, 2025 updated by: Hanna Lahteenmaki
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.
Study Overview
Status
Enrolling by invitation
Intervention / Treatment
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 Type
Interventional
Enrollment (Estimated)
50
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Uusimaa
-
Helsinki, Uusimaa, Finland, FI-00014
- Department of Oral and Maxillofacial Diseases, Head and Neck Center
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- the participation previously study implant patient
Exclusion Criteria:
- has not received antibiotic treatment within 6 months
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Screening
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Other: patients who had participated in a previous study
Bleeding on probing, Peri-implant pocket depth, x-ray findings and aMMP-8 tests will be taking.
|
peri-implant mucositis, peri-implantitis
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Tratitional measurement
Time Frame: 5 years
|
the depth of the implant's gum pocket
|
5 years
|
|
Traditional measure
Time Frame: through study completion, an average of 5 year
|
Bleedin on probing
|
through study completion, an average of 5 year
|
|
Biomarker test
Time Frame: through study completion, an average of 5 year
|
aMMP-8 tests, taking peri-implant sulcus fluid
|
through study completion, an average of 5 year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Study Director: Timo Sorsa, Professor, University of Helsinki
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Tonetti 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. Erratum In: J Periodontol. 2018 Dec;89(12):1475. doi: 10.1002/jper.10239.
- 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.
- Natto 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.
- Sorsa 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 11, 2025
Primary Completion (Estimated)
September 11, 2025
Study Completion (Estimated)
November 20, 2025
Study Registration Dates
First Submitted
September 25, 2024
First Submitted That Met QC Criteria
January 6, 2025
First Posted (Actual)
March 25, 2025
Study Record Updates
Last Update Posted (Actual)
March 25, 2025
Last Update Submitted That Met QC Criteria
March 5, 2025
Last Verified
March 1, 2025
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 20092024
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.