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Evaluation of the Effects of Routine Phase I Periodontal Therapy on Clinical Parameters and Levels of Gremlin-1, CTHRC1, and Tenascin-C in Gingival Crevicular Fluid and Peri-Implant Sulcular Fluid in Individuals With Periodontitis and Peri-Implantitis

Evaluation of the Effects of Routine Phase I Periodontal Therapy on Clinical Parameters and Levels of Gremlin-1, CTHRC1, and Tenascin-C in Gingival Crevicular Fluid and Peri-Implant Sulcular Fluid in Individuals With Periodontitis and Peri-Implantitis

Status
Not yet recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07797127
Enrollment
30
Registered
2026-09-01
Start date
2026-09-01
Completion date
2027-11-01
Last updated
2026-09-01

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

Conditions

Periimplantitis, Periodontitis

Keywords

Phase I Periodontal Therapy, Gingival Crevicular Fluid, Peri-Implant Sulcular Fluid, Biomarkers, Gremlin-1, CTHRC1, Tenascin-C

Brief summary

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.

Detailed description

The primary objective 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)-performed in accordance with standard protocols-on these pathological processes. Individuals concurrently diagnosed with both periodontitis and peri-implantitis will be included in the study. In our study, the tissue biomarker levels of Gremlin-1, which inhibits bone regeneration via BMP antagonist activity; CTHRC1, which induces osteogenic differentiation by activating the Wnt/β-catenin signaling pathway; and Tenascin-C, which reflects extracellular matrix degradation during the inflammatory process, will be investigated. Gingival crevicular fluid (GCF) and peri-implant sulcular fluid (PISF) samples will be collected from these subjects prior to treatment (T0) and at the one-month post-treatment follow-up visit (T1). The obtained biomarker levels will be quantitatively analyzed using the enzyme-linked immunosorbent assay (ELISA) method. Through the acquired data, it is aimed to elucidate the differences in bone remodeling (coupling) dynamics around implants compared to the bone metabolism around natural teeth, thereby providing a scientific rationale for the development of novel diagnostic approaches and targeted therapeutic strategies.

Interventions

PROCEDURERoutine Phase I Non-Surgical Periodontal Therapy

Routine non-surgical periodontal and peri-implant treatment consisting of scaling and root planing (SRP) and oral hygiene instructions.

Sponsors

Adiyaman University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes

Inclusion criteria

* 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. * No use of medications that could affect study outcomes (mouthwashes, antibiotics, non-steroidal anti-inflammatory drugs \[NSAIDs\], corticosteroids) in the 3 months prior to sampling. * For the Test Group: Concurrent presence of both Peri-implantitis (bleeding on probing/suppuration, PD \>= 5mm, radiographic bone loss \>= 2mm) and Periodontitis (Generalized Stage III-IV, presence of bleeding on probing and clinical attachment loss) in the same oral cavity. * For the Control Group: Completely healthy periodontal and peri-implant tissues (negative bleeding on probing, PD \<= 3mm, no bone loss), with a low plaque index score (\<20%) and good oral hygiene.

Exclusion criteria

* 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. * Presence of faulty restorations, overhanging fillings, or removable prosthesis clasps that increase plaque accumulation on the tooth or implant to be examined (to eliminate local factors). * Detection of mobility in the implant to be examined (this is considered implant failure/loss, not just peri-implantitis). * Presence of active orthodontic treatment (brackets/wires) in the regions where samples will be collected.

Design outcomes

Primary

MeasureTime frameDescription
Change in GCF and PISF Biomarker Levels (Gremlin-1, CTHRC1, Tenascin-C).Baseline (T0) and 1 month post-treatment (T1).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

MeasureTime frameDescription
Change in Probing Pocket Depth (PPD)Baseline (T0) and 1 month post-treatment (T1).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)Baseline (T0) and 1 month post-treatment (T1).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).Baseline (T0) and 1 month post-treatment (T1).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)Baseline (T0) and 1 month post-treatment (T1).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.
Change in Bleeding on Probing (BOP).Baseline (T0) and 1 month post-treatment (T1).The presence of bleeding upon probing will be recorded and expressed as a percentage of bleeding sites (%). Higher percentages indicate more widespread inflammation. A reduction in the BOP percentage indicates a better clinical outcome.

Countries

Turkey (Türkiye)

Contacts

CONTACTYusuf Onur Erdem, DDS
yerdem@adiyaman.edu.tr+90543811002

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Sep 2, 2026