About this trial
The aim of this study is to compare the mechanisms of tissue destruction between natural teeth with periodontitis and implants with peri-implantitis within the same individual, and to evaluate the effects of routine Phase I periodontal therapy (scaling and root planing, and oral hygiene instruction). In this study, the tissue biomarker levels of Gremlin-1, CTHRC1, and Tenascin-C will be investigated. Gingival crevicular fluid (GCF) and peri-implant sulcular fluid (PISF) samples will be collected from subjects concurrently diagnosed with both periodontitis and peri-implantitis.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Aged between 18 and 65 years and providing written informed consent.
Systemically healthy (absence of diabetes, osteoporosis, immunological diseases, etc.).
Having a dental implant with prosthetic loading that has been in function for at least 1 year.
No history of periodontal treatment within the last 6 months.
Disqualifiers
Current use of smoking and tobacco products (or having quit within the last 5 years).
History of any periodontal or peri-implant surgical/non-surgical treatment within the last 6 months.
Use of antibiotics, anti-inflammatory drugs (NSAIDs), or immunosuppressive drugs within the last 3 months.
Pregnancy, lactation (breastfeeding), or use of oral contraceptives.
Trial population
The study population consists of systemically healthy male and female adults, aged 18 to 65 years, who apply to the Adıyaman University Faculty of Dentistry, Department of Periodontology. The test group includes patients concurrently diagnosed with both Generalized Stage III-IV Periodontitis and Peri-implantitis. The control group consists of individuals with completely healthy periodontal and peri-implant tissues.
Trial design
Cohort
Prospective
Treatments tested in this trial
Routine Phase I Non-Surgical Periodontal Therapy
Procedure/SurgeryRoutine non-surgical periodontal and peri-implant treatment consisting of scaling and root planing (SRP) and oral hygiene instructions.
Treatment groups
Trial outcomes
Primary outcomes
Change in GCF and PISF Biomarker Levels (Gremlin-1, CTHRC1, Tenascin-C).
The concentrations of Gremlin-1, CTHRC1, and Tenascin-C proteins in gingival crevicular fluid (GCF) and peri-implant sulcular fluid (PISF) will be quantified using highly sensitive Enzyme-Linked Immunosorbent Assay (ELISA) kits. The values will be measured in picograms per milliliter (pg/mL) to evaluate the immunological response to Phase I therapy.
Secondary outcomes
Change in Probing Pocket Depth (PPD)
Probing Pocket Depth (PPD) will be measured in millimeters (mm). Higher measurement values indicate deeper periodontal pockets and a worse clinical condition. A reduction in PPD from baseline to post-treatment indicates a better clinical outcome.
Change in Clinical Attachment Level (CAL)
Clinical Attachment Level (CAL) will be recorded in millimeters (mm). Higher measurement values indicate greater clinical attachment loss and a worse condition. A reduction in CAL values indicates clinical improvement and a better outcome.
Change in Plaque Index (PI).
Plaque accumulation will be evaluated using the Plaque Index (scale: 0-3). Higher scores indicate greater plaque accumulation and a worse clinical condition. A decrease in scores over time indicates a better clinical outcome.
Change in Gingival Index (GI)
Gingival inflammation will be evaluated using the Gingival Index (scale: 0-3). Higher scores indicate more severe gingival inflammation and a worse condition. A decrease in scores over time indicates a better clinical outcome.
Sponsors and contacts
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