Salivary Biomarkers in Different Implant-Supported Prostheses

NCT07813845 | Completed

• 2 other identifiers: TBAEK-768TDH-2025-6927
• Study Type: observational
• Target: 107
• Locations: 1 country
• Sites: 1

Brief Summary

This observational cross-sectional study compared salivary biomarkers among adults with different types of implant-supported prosthetic rehabilitation and periodontally healthy adults with natural teeth. A total of 107 participants were included in four groups: periodontally healthy individuals with natural teeth, patients with implant-supported partial fixed prostheses and remaining natural teeth, patients with full-arch fixed implant-supported prostheses, and patients with implant-retained overdentures. The study measured three biomarkers in unstimulated whole saliva: secretory immunoglobulin A (sIgA), matrix metalloproteinase-8 (MMP-8), and matrix metalloproteinase-9 (MMP-9). These biomarkers are related to oral immune responses and tissue remodeling. The main aim was to determine whether salivary biomarker levels differed according to dentition status and type of implant-supported prosthesis. The study also examined relationships between these biomarkers and clinical parameters, including probing depth. No experimental treatment or intervention was assigned by the study protocol.

Conditions

Peri-Implant Diseases

Keywords

Salivary Biomarkers; Dental Implants; ımplant-Supported Prosthesis; Secretory Immunoglobulin A; MMP-8; MMP-9

Outcome Measures

Primary Outcomes (3)

• Salivary MMP-9 Concentration

  Concentration of matrix metalloproteinase-9 (MMP-9) in unstimulated whole saliva, measured using enzyme-linked immunosorbent assay (ELISA) and reported in ng/mL.

  At saliva collection, a single time point at least 24 hours after the clinical examination.

• Salivary MMP-8 Concentration

  Concentration of matrix metalloproteinase-8 (MMP-8) in unstimulated whole saliva, measured using enzyme-linked immunosorbent assay (ELISA) and reported in ng/mL.

  At saliva collection, a single time point at least 24 hours after the clinical examination.

• Salivary Secretory Immunoglobulin A Concentration

  Concentration of secretory immunoglobulin A (sIgA) in unstimulated whole saliva, measured using enzyme-linked immunosorbent assay (ELISA) and reported in µg/mL.

  At saliva collection, a single time point at least 24 hours after the clinical examination.

Secondary Outcomes (2)

• Association Between Salivary Biomarkers and Probing Depth

  Clinical probing depth measured at the study visit, with saliva collected at least 24 hours after the clinical examination.

• Discriminative Ability of Salivary Biomarkers Across Study Groups

  At saliva collection, a single time point at least 24 hours after the clinical examination.

Study Arms (4)

Periodontally Healthy Dentate Group

Periodontally healthy, fully dentate participants without dental implants. Periodontal health was defined according to the 2017 World Workshop classification, with probing depths of 3 mm or less at all sites and full-mouth bleeding on probing below 10%.

Partial Fixed Prosthesis Group

Participants with remaining natural teeth and an implant-supported partial fixed prosthesis that had been in function for at least 6 months.

Full-Arch Fixed Prosthesis Group

Participants rehabilitated with a full-arch fixed implant-supported prosthesis, with the definitive prosthesis in function for at least 6 months.

Implant-Retained Overdenture Group

Participants rehabilitated with an implant-retained overdenture, with the definitive prosthesis in function for at least 6 months.

Eligibility Criteria

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

Study Population

Adults attending the Department of Prosthodontics, Faculty of Dentistry, Akdeniz University were recruited and classified according to their existing dentition and prosthetic status. The study population included periodontally healthy fully dentate individuals without implants and patients rehabilitated with implant-supported partial fixed prostheses, full-arch fixed implant-supported prostheses, or implant-retained overdentures. Prosthetic rehabilitation was present before enrollment and was not assigned by the study protocol.

You may qualify if:

• Age 18 years or older.
• Ability and willingness to provide written informed consent.
• For the healthy dentate group: fully dentate individuals without dental implants who were systemically and periodontally healthy, with probing depths of 3 mm or less at all sites and full-mouth bleeding on probing below 10%.
• For the implant groups: presence of an implant-supported partial fixed prosthesis, full-arch fixed implant-supported prosthesis, or implant-retained overdenture with osseointegrated implants restored with a definitive prosthesis in function for at least 6 months.

You may not qualify if:

• Antibiotic use within the preceding 6 months.
• Periodontal therapy within the preceding 6 months.
• Systemic conditions known to affect periodontal or immune status, including diabetes mellitus, cardiovascular disease, rheumatoid arthritis, systemic lupus erythematosus, or inflammatory bowel disease.
• Systemic infectious diseases, including tuberculosis, hepatitis, or human immunodeficiency virus infection.
• Mucocutaneous diseases affecting the oral mucosa, including lichen planus, pemphigus vulgaris, or chronic ulcerative stomatitis.
• Ongoing systemic corticosteroid, immunosuppressant, or biologic therapy.
• Pregnancy or lactation.

Sponsors & Collaborators

• Akdeniz University: lead

Study Sites (1)

Akdeniz University Faculty of Dentistry

Antalya, Antalya, 07058, Turkey (Türkiye)

Location

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 26, 2026
• First Posted: September 10, 2026
• Study Start: August 1, 2025
• Primary Completion: February 1, 2026
• Study Completion: February 1, 2026
• Last Updated: September 10, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)