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NCT Number: NCT07797127

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

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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Adıyaman University Faculty of Dentistry, Department of Periodontology

Adıyaman, Adıyaman Province, 02040, Turkey (Türkiye)

Location contact

Yusuf Onur Erdem, DDS

CONTACT

[email protected]

+905438411002

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Routine Phase I Non-Surgical Periodontal Therapy

Procedure

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

Primary outcomes

  1. Change in GCF and PISF Biomarker Levels (Gremlin-1, CTHRC1, Tenascin-C).

    Time frame: 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 outcomes

  1. Change in Probing Pocket Depth (PPD)

    Time frame: 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.

  2. Change in Clinical Attachment Level (CAL)

    Time frame: 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.

  3. Change in Plaque Index (PI).

    Time frame: 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.

  4. Change in Gingival Index (GI)

    Time frame: 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.

  5. Change in Bleeding on Probing (BOP).

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Yusuf Onur Erdem, DDS

CONTACT

[email protected]

+90543811002

Sponsors and collaborators

Lead sponsor

Adiyaman University

Other

Registry information

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Sep 1, 2026
Registry last updated
Sep 1, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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