NCT06761521

Brief 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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 25, 2024

Completed
3 months until next milestone

First Posted

Study publicly available on registry

January 7, 2025

Completed
4 days until next milestone

Study Start

First participant enrolled

January 11, 2025

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 11, 2025

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 20, 2025

Completed
Last Updated

March 6, 2025

Status Verified

March 1, 2025

Enrollment Period

8 months

First QC Date

September 25, 2024

Last Update Submit

March 5, 2025

Conditions

Peri-Implant HealthPeri-Implantitis and Peri-implant Mucositis

Keywords

Ammp-8Peri-implant diseasesmucositispreventionmaintenance

Outcome Measures

Primary Outcomes (3)

  • Tratitional measurement

    the depth of the implant's gum pocket

    5 years

  • Traditional measure

    Bleedin on probing

    through study completion, an average of 5 year

  • Biomarker test

    aMMP-8 tests, taking peri-implant sulcus fluid

    through study completion, an average of 5 year

Study Arms (1)

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.

Diagnostic Test: Peri-Implantitis and Peri-implant mucositis

Interventions

Peri-Implantitis and Peri-implant mucositisDIAGNOSTIC_TEST

peri-implant mucositis, peri-implantitis

patients who had participated in a previous study

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • the participation previously study implant patient

You may not qualify if:

  • has not received antibiotic treatment within 6 months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Oral and Maxillofacial Diseases, Head and Neck Center

Helsinki, Uusimaa, FI-00014, Finland

Location

Related Publications (4)

  • 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.

    PMID: 32764436BACKGROUND

  • 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.

    PMID: 30557088BACKGROUND

  • 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.

    PMID: 20937384BACKGROUND

  • 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.

    PMID: 29926952BACKGROUND

MeSH Terms

Conditions

Peri-ImplantitisMucositis

Condition Hierarchy (Ancestors)

Periodontal DiseasesMouth DiseasesStomatognathic DiseasesGastroenteritisGastrointestinal DiseasesDigestive System Diseases

Study Officials

  • Timo Sorsa, Professor

    University of Helsinki

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SCREENING
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Doctor, Dental hygienist

Study Record Dates

First Submitted

September 25, 2024

First Posted

January 7, 2025

Study Start

January 11, 2025

Primary Completion

September 11, 2025

Study Completion

November 20, 2025

Last Updated

March 6, 2025

Record last verified: 2025-03

Data Sharing

IPD Sharing
Will not share

Locations

FI(1)