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

NCT07584759 | Completed

• 2 other identifiers: E-60116787-020-6042712025DİŞF001
• Study Type: observational
• Target: 59
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

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

Outcome Measures

Primary Outcomes (5)

• Calprotectin levels in peri-implant crevicular fluid

  After 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.

  6-8 week after prosthetic treatment

• Sclerostin levels in peri-implant crevicular fluid

  After 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.

  6-8 week after prosthetic treatment

• NTx levels in peri-implant crevicular fluid

  After 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.

  6-8 week after prosthetic treatment

• MMP-8 levels in peri-implant crevicular fluid

  After 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.

  6-8 week after prosthetic treatment

• MMP-9 levels in peri-implant crevicular fluid

  After 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.

  6-8 week after prosthetic treatment

Other Outcomes (6)

• Radiographic detecting of Peri-implant marginal bone loss

  Baseline, 3 months

• Modified Bleeding İndex

  During the same session as the peri-implant fluid collection procedure

• Peri-implant pocket depth

  During the same session as the peri-implant fluid collection procedure

Study Arms (2)

Test

Presence of marginal bone loss of 1 mm or more within the first 3 months after implant placement

Other: Collecting of peri-implant sulcus fluid; Diagnostic Test: Periapical radiography

Control

Presence of less than 1 mm of marginal bone loss within the first 3 months after implant placement

Other: Collecting of peri-implant sulcus fluid; Diagnostic Test: Periapical radiography

Interventions

Collecting of peri-implant sulcus fluid OTHER

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

Control; Test

Periapical radiography DIAGNOSTIC_TEST

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

Control; Test

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients who received implant treatment at the Department of Periodontology, Pamukkale University Faculty of Dentistry.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Pamukkale University: lead
• Pamukkale University scientific research project department: collaborator

Study Sites (1)

Pamukkale University, Faculty of Dentistry, Periodontology

Denizli, 20160, Turkey (Türkiye)

Location

Biospecimen

Retention: SAMPLES WITH DNA

peri-implant crevicular fluid

MeSH Terms

Conditions

Sclerosteosis

Study Officials

• Raziye Tugce Can Keles, R.A.

  Pamukkale University Faculty of Dentistry, Department of Periodontology

  PRINCIPAL INVESTIGATOR

• Gizem Torumtay Cin, Assoc. Prof.

  Pamukkale University Faculty of Dentistry, Department of Periodontology

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Assistant

Study Record Dates

• First Submitted: May 3, 2026
• First Posted: May 13, 2026
• Study Start: March 6, 2025
• Primary Completion: September 6, 2025
• Study Completion: September 6, 2025
• Last Updated: May 13, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)