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Not yet recruitingNCT07797127Updated Sep 1, 2026

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

An observational study in Periimplantitis and Periodontitis, sponsored by Adiyaman University. Not yet recruiting at 1 site in Turkey (Türkiye). Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-09-01.

Sponsored by Adiyaman University · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
30
Ages
18 Years to 65 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Periimplantitis
  • Periodontitis

Keywords

  • Phase I Periodontal Therapy
  • Gingival Crevicular Fluid
  • Peri-Implant Sulcular Fluid
  • Biomarkers
  • Gremlin-1
  • CTHRC1
  • Tenascin-C
03

In context

Peri-Implantitis

322 studies on the registry are indexed under Peri-Implantitis; 88 are open to participants now.

This study's planned enrollment of 30 is below the median of 83 across 121 observational studies indexed under Peri-Implantitis.

Browse Peri-Implantitis studies →

Lead sponsor

Adiyaman University is the lead sponsor of 31 studies on the registry; 11 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Aged between 18 and 65 years and providing written .
  • 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], ) 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

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 drugs within the last 3 months.
  • Pregnancy, lactation (breastfeeding), or use of oral .
  • 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.
Terms in these criteria, in plain language(4)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

Immunosuppression

A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.

Read whether the line is about a condition or about medicines, and which medicines and doses it means.

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
30 participants (estimated)
Patient registry
No
Biospecimen retention
Samples without dna

Groups and cohorts

  • 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

  • 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.

06

What researchers measure

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.

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

Secondary outcomes

  1. 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.

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

  2. 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.

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

  3. 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.

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

  4. 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.

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

  5. Change in Bleeding on Probing (BOP).

    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.

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

07

Study locations

1 site
  • Adıyaman University Faculty of Dentistry, Department of Periodontology
    Adıyaman, Adıyaman Province 02040, Turkey (Türkiye)
08

References and documents

Individual participant data

Plan to share: No — ndividual participant data will not be publicly shared due to strict ethical restrictions, institutional policies, and patient confidentiality. However, the datasets generated and analyzed during the current study may be available from the corresponding author upon reasonable academic request, subject to approval by the local ethics committee.

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Sep 2026; primary completion for Mar 2027, 6 months later.

Of 33 non-industry observational studies under Peri-Implantitis, half reached primary completion within 17 months of starting (the median), counting those still running; a quarter within 8 and three quarters within 77. This study's planned 6 months is below that.

Counting every sponsor, half of 35 studies reached it within 17 months; a quarter within 8 and three quarters within 77.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 16, 2026
First posted
Sep 1, 2026
StartEst.
Sep 1, 2026
Primary completionEst.
Mar 1, 2027
CompletionEst.
Nov 1, 2027
Last update
Sep 1, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 1, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07797127
Lead sponsor
Adiyaman University
Responsible party
Yusuf Onur Erdem (Research Assistant, Department of Periodontology, Adiyaman University) — Principal investigator
First posted
Sep 1, 2026
Start date
Sep 1, 2026 (estimated)
Primary completion
Mar 1, 2027 (estimated)
Completion
Nov 1, 2027 (estimated)
Last update
Sep 1, 2026

Study contacts

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

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.

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