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Evaluation of Fluid Biomarkers Around Implants Exhibiting Early Stage Periimplant Bone Loss

Evaluation of Biomarkers Involved In Bone Metabolism (Remodeling) In Periimplanter Crevicular Fluid of Implants With Early Marginal Bone Loss: A Retrospective Clinical Study

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07584759
Enrollment
59
Registered
2026-05-13
Start date
2025-03-06
Completion date
2025-09-06
Last updated
2026-05-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Marginal Bone Loss, Peri-implant Bone Loss, Peri-Implant Health, Peri-implant Marginal Bone Loss

Keywords

implant, marginal bone loss, peri-implant sulcular fluid, sclerostin, calprotectin, matrix metalloproteinases, n-terminal type I collagen telopeptide

Brief summary

This study aimed to compare biological mediators known to be important in peri-implant diseases in implants with and without early stage marginal bone loss. A total of 118 implants in 59 patients were designated as test and control groups. The radiographic and periodontal data of the included implants, along with peri-implant sulcus fluid samples, were evaluated.

Detailed description

This study included clinical and radiographic records of patients who received implant treatment in the maxilla and/or mandible between 11/2021 and 9/2024. Patients were divided into test and control groups based on the presence/absence of EMBL after prosthetic loading. Periodontal clinical measurements were recorded and peri-implant sulcus fluid (PISF) samples were collected. Sclerostin, calprotectin, type I collagen cross-linked N-telopeptide (NTx), matrix metalloproteinase (MMP)-8, and MMP-9 levels were analyzed using ELISA. Group comparisons were performed with the statistical analyses.

Interventions

OTHERCollecting of peri-implant sulcus fluid

To evaluate biomarkers associated with peri-implant bone loss, periopaper was placed in the peri-implant pocket and absorbed with sulcus fluid.

DIAGNOSTIC_TESTPeriapical radiography

Parallel cone technique was used during periapical imaging to accurately measure peri-implant bone loss.

Sponsors

Pamukkale University
Lead SponsorOTHER
Pamukkale University scientific research project department
CollaboratorUNKNOWN

Study design

Observational model
CASE_CONTROL
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Healthy volunteers
Yes

Inclusion criteria

* Presence of 1 mm or more of radiographic marginal bone loss within the first 3 months after implant placement * Availability of radiographic documentation * Availability of demographic data, surgical records, and data related to the implant used * Physical condition classified as Class I and II according to the American Society of Anesthesiologists (ASA) classification * Patients with no smoking history in the last 10 years * Fixed implant-supported restorations * Screw-retained implants

Exclusion criteria

* Patients receiving and/or maintaining implant treatment at centers other than the Department of Periodontology, Pamukkale University Faculty of Dentistry * Patients with incomplete or unreachable files or radiographic documentation * Patients with a known systemic disease/condition that alters their physical condition or bone metabolism * Severe bruxism cases * Pregnant and breastfeeding patients * Patients with incomplete implant-supported prosthesis * Areas grafted during or before implant surgery * Removable implant-supported restorations * Cement-retained implants * Patients undergoing peri-implantitis treatment

Design outcomes

Primary

MeasureTime frameDescription
Calprotectin levels in peri-implant crevicular fluid6-8 week after prosthetic treatmentAfter collecting peri-implant sulcus fluid using the paper strip method, calprotectin levels in the peri-implant sulcus region were determined using the ELISA method and recorded in ng/ml.
Sclerostin levels in peri-implant crevicular fluid6-8 week after prosthetic treatmentAfter collecting peri-implant sulcus fluid using the paper strip method, sclerostin levels in the peri-implant sulcus region were determined using the ELISA method and recorded in pg/ml.
NTx levels in peri-implant crevicular fluid6-8 week after prosthetic treatmentAfter collecting peri-implant sulcus fluid using the paper strip method, NTx levels in the peri-implant sulcus region were determined using the ELISA method and recorded in ng/ml.
MMP-8 levels in peri-implant crevicular fluid6-8 week after prosthetic treatmentAfter collecting peri-implant sulcus fluid using the paper strip method, MMP-8 levels in the peri-implant sulcus region were determined using the ELISA method and recorded in ng/ml.
MMP-9 levels in peri-implant crevicular fluid6-8 week after prosthetic treatmentAfter collecting peri-implant sulcus fluid using the paper strip method, MMP-9 levels in the peri-implant sulcus region were determined using the ELISA method and recorded in ng/ml.

Countries

Turkey (Türkiye)

Contacts

PRINCIPAL_INVESTIGATORRaziye Tugce Can Keles, R.A.

Pamukkale University Faculty of Dentistry, Department of Periodontology

STUDY_DIRECTORGizem Torumtay Cin, Assoc. Prof.

Pamukkale University Faculty of Dentistry, Department of Periodontology

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: May 14, 2026