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

NCT07797127 | Not Yet Recruiting

• 1 other identifier: 2026/2-13
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Periimplantitis; Periodontitis

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline (T0) and 1 month post-treatment (T1).

Secondary Outcomes (5)

• Change in Probing Pocket Depth (PPD)

  Baseline (T0) and 1 month post-treatment (T1).

• Change in Clinical Attachment Level (CAL)

  Baseline (T0) and 1 month post-treatment (T1).

• Change in Plaque Index (PI).

  Baseline (T0) and 1 month post-treatment (T1).

• Change in Gingival Index (GI)

  Baseline (T0) and 1 month post-treatment (T1).

• Change in Bleeding on Probing (BOP).

  Baseline (T0) and 1 month post-treatment (T1).

Study Arms (2)

Periodontitis and Peri-implantitis Group

Patients concurrently diagnosed with both periodontitis and peri-implantitis. Gingival crevicular fluid (GCF) and peri-implant sulcular fluid (PISF) samples will be collected at baseline (T0) and one month post-treatment (T1).

Procedure: Routine Phase I Non-Surgical Periodontal Therapy

Periodontally Healthy Control Group

Volunteers with clinically healthy periodontal and peri-implant tissues. Gingival crevicular fluid (GCF) and peri-implant sulcular fluid (PISF) samples will be collected at a single time point to serve as a healthy baseline reference.

Interventions

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.

Periodontitis and Peri-implantitis Group

Eligibility Criteria

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

Study 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Adiyaman University: lead

Study Sites (1)

Adıyaman University Faculty of Dentistry, Department of Periodontology

Adıyaman, Adıyaman Province, 02040, Turkey (Türkiye)

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Gingival crevicular fluid (GCF) and peri-implant sulcular fluid (PISF) samples will be collected using paper strips and retained for protein biomarker analysis via the ELISA method.

MeSH Terms

Conditions

Peri-Implantitis; Periodontitis; Polyposis Syndrome, Hereditary Mixed, 1

Condition Hierarchy (Ancestors)

Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

Central Study Contacts

Yusuf Onur Erdem, DDS

CONTACT

+90543811002; yerdem@adiyaman.edu.tr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Assistant, Department of Periodontology

Study Record Dates

• First Submitted: August 16, 2026
• First Posted: September 1, 2026
• Study Start: September 1, 2026
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): November 1, 2027
• Last Updated: September 1, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)