NCT06408467

Brief 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2022

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

January 1, 2022

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2022

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 15, 2022

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

May 2, 2024

Completed
8 days until next milestone

First Posted

Study publicly available on registry

May 10, 2024

Completed
Last Updated

May 10, 2024

Status Verified

May 1, 2024

Enrollment Period

6 months

First QC Date

May 2, 2024

Last Update Submit

May 6, 2024

Conditions

Keywords

peri-implant treatmentaMMP-8non-surgical treatment

Outcome Measures

Primary Outcomes (3)

  • the result of the participants who were measured aMMP-8

    Measure aMMP-8-level ng/ml

    1 month

  • the result of the participants who were measured BOP

    measure bleeding on probing in PISF

    1 month

  • the result of the participants who were measured PPD

    measure peri-implant pocket depth

    1 month

Study Arms (1)

The effect and monitoring of maintenance therapy for peri-implantitis

EXPERIMENTAL
Other: aMMP-8 diagnostic test

Interventions

40 patients

The effect and monitoring of maintenance therapy for peri-implantitis

Eligibility Criteria

Age25 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • Smoking
  • age under 25
  • antibiotic treatment within six months
  • the maintenance treatment had been completed within 6 months.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Helsinki

Helsinki, 00029, Finland

Location

Related Publications (5)

  • 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.

  • Figuero 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.

  • 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.

  • Alassy 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.

  • Lahteenmaki 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.

MeSH Terms

Conditions

Peri-Implantitis

Condition Hierarchy (Ancestors)

Periodontal DiseasesMouth DiseasesStomatognathic Diseases

Study Officials

  • Timo Sorsa, Professor

    University of Helsinki

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 2, 2024

First Posted

May 10, 2024

Study Start

January 1, 2022

Primary Completion

July 1, 2022

Study Completion

November 15, 2022

Last Updated

May 10, 2024

Record last verified: 2024-05

Data Sharing

IPD Sharing
Will share

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

Shared Documents
STUDY PROTOCOL, SAP, CSR
Time Frame
starting in June 2025 and end of January 2026
Access Criteria
information can be shared with an email request to share IPD and other support information. Requests are reviewed with the research team.

Locations