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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT06408467
Other study ID # Lahanna
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date January 1, 2022
Est. completion date November 15, 2022

Study information

Verified date May 2024
Source Lahanna oy
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 40
Est. completion date November 15, 2022
Est. primary completion date July 1, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 25 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Other:
aMMP-8 diagnostic test
40 patients

Locations

Country Name City State
Finland University of Helsinki Helsinki

Sponsors (2)

Lead Sponsor Collaborator
Lahanna oy University of Helsinki

Country where clinical trial is conducted

Finland, 

References & Publications (4)

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. — View Citation

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. — View Citation

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 i — View Citation

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary the result of the participants who were measured aMMP-8 Measure aMMP-8-level ng/ml 1 month
Primary the result of the participants who were measured BOP measure bleeding on probing in PISF 1 month
Primary the result of the participants who were measured PPD measure peri-implant pocket depth 1 month
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