PeriimplantitisNCT07797127
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 of Periimplantitis and Periodontitis, run by Adiyaman University at 1 site in Turkey (Türkiye).
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Periimplantitis, Periodontitis
- What is being tested?
- Routine Phase I Non-Surgical Periodontal Therapy
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- How many people
- 30 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Sep 2026to 1 Nov 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site
Adıyaman University Faculty of Dentistry, Department of Periodontology
Adıyaman, Adıyaman Province, 02040
Yusuf Onur Erdem, DDS, +905438411002, yerdem@adiyaman.edu.tr
About this study
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.
- Conditions
- Periimplantitis, Periodontitis
- Being tested
- Routine Phase I Non-Surgical Periodontal Therapy
- Keywords
- Phase I Periodontal Therapy, Gingival Crevicular Fluid, Peri-Implant Sulcular Fluid, Biomarkers, Gremlin-1, CTHRC1, Tenascin-C
- Medical subject headings
- Peri-Implantitis, Periodontitis, Polyposis Syndrome, Hereditary Mixed, 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Routine Phase I Non-Surgical Periodontal TherapyProcedure or surgery
Routine non-surgical periodontal and peri-implant treatment consisting of scaling and root planing (SRP) and oral hygiene instructions.
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline (T0) and 1 month post-treatment (T1).
Secondary outcomes (5)
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.
Measured: Baseline (T0) and 1 month post-treatment (T1).
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.
Measured: Baseline (T0) and 1 month post-treatment (T1).
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.
Measured: Baseline (T0) and 1 month post-treatment (T1).
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.
Measured: Baseline (T0) and 1 month post-treatment (T1).
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.
Measured: Baseline (T0) and 1 month post-treatment (T1).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2026
- Study start1 Sep 2026 (estimated)
- Primary completion1 Mar 2027 (estimated)
- Study completion1 Nov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PeriimplantitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Adiyaman University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yusuf Onur Erdem, Adiyaman University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07797127
- Sponsor's protocol ID
- 2026/2-13
- Status last verified
- Aug 2026
- First submitted
- 16 Aug 2026
- Last updated
- 1 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07797127
- Acronym / sponsor ID
- 2026/2-13
- Conditions
- Periimplantitis, Periodontitis
- Keywords
- Phase I Periodontal Therapy, Gingival Crevicular Fluid, Peri-Implant Sulcular Fluid, Biomarkers, Gremlin-1, CTHRC1, Tenascin-C
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Adiyaman UniversityUniversity, hospital or other
- Study start
- 1 Sep 2026 (estimated)
- Primary completion
- 1 Mar 2027 (estimated)
- Study completion
- 1 Nov 2027 (estimated)
- First posted
- 1 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Periodontitis and Peri-implantitis Group | – | Procedure: Routine Phase I Non-Surgical Periodontal TherapyPatients 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). |
| 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (7 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Routine Phase I Non-Surgical Periodontal TherapyRoutine non-surgical periodontal and peri-implant treatment consisting of scaling and root planing (SRP) and oral hygiene instructions. | Procedure or surgery | Periodontitis and Peri-implantitis Group |
Primary outcome
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.
5 secondary outcomes
Change in Probing Pocket Depth (PPD)
Time frame: Baseline (T0) and 1 month post-treatment (T1).
Change in Clinical Attachment Level (CAL)
Time frame: Baseline (T0) and 1 month post-treatment (T1).
Change in Plaque Index (PI).
Time frame: Baseline (T0) and 1 month post-treatment (T1).
Change in Gingival Index (GI)
Time frame: Baseline (T0) and 1 month post-treatment (T1).
Change in Bleeding on Probing (BOP).
Time frame: Baseline (T0) and 1 month post-treatment (T1).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Sep 2026.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Periimplantitis and Periodontitis, run by Adiyaman University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 1 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yusuf Onur Erdem, DDS (+90543811002, yerdem@adiyaman.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in GCF and PISF Biomarker Levels (Gremlin-1, CTHRC1, Tenascin-C). (time frame: Baseline (T0) and 1 month post-treatment (T1).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Sep 2026.