Monitoring of Non-Surgical Treatment of Peri-implantitis

May 6, 2024 updated by: Lahanna oy

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

40

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

  • Finland
      • Helsinki, Finland, 00029
        • University of Helsinki

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria

  • Smoking
  • age under 25
  • antibiotic treatment within six months
  • the maintenance treatment had been completed 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: Prevention
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: The effect and monitoring of maintenance therapy for peri-implantitis
Other: aMMP-8 diagnostic test
40 patients

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
the result of the participants who were measured aMMP-8
Time Frame: 1 month
Measure aMMP-8-level ng/ml
1 month
the result of the participants who were measured BOP
Time Frame: 1 month
measure bleeding on probing in PISF
1 month
the result of the participants who were measured PPD
Time Frame: 1 month
measure peri-implant pocket depth
1 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Lahanna oy

Collaborators

University of Helsinki

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

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 1, 2022

Primary Completion (Actual)

July 1, 2022

Study Completion (Actual)

November 15, 2022

Study Registration Dates

First Submitted

May 2, 2024

First Submitted That Met QC Criteria

May 6, 2024

First Posted (Actual)

May 10, 2024

Study Record Updates

Last Update Posted (Actual)

May 10, 2024

Last Update Submitted That Met QC Criteria

May 6, 2024

Last Verified

May 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Lahanna

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

There is a plan to make IPD and related data dictionaries available after the research

IPD Sharing Time Frame

starting in June 2025 and end of January 2026

IPD Sharing Access Criteria

information can be shared with an email request to share IPD and other support information. Requests are reviewed with the research team.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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.

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