Periodontal InflammationNCT06727929
The Effect of Non-surgical Periodontal Treatment on Dickkoff-1 and Secreted Frizzled Related Protein-5 Levels
An observational study of Periodontal Inflammation and Alveolar Bone Loss, run by Cumhuriyet University at 1 site in Turkey (Türkiye).
Trial summary
Periodontitis is a condition that is defined by microbial-associated, host-induced inflammation, which ultimately results in the loss of periodontal attachment.Periodontal clinical parameters are the most reliable indicators of periodontal disease; however, they provide information about past tissue destruction and… Read more about this study
- Who is it for?
- Ages 20 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Periodontal Inflammation, Alveolar Bone Loss, Periodontal Diseases
- What is being tested?
- Collection of gingival crevicular fluid, ELISA
- How many people
- 99 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Mar 2024to 1 Jan 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
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 20 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: A total of 99 patients (44 males and 55 females) between 20-50 years of age were included and were divided into three groups as follows: periodontally healthy, patients with gingivitis, and patients with stage 3 grade B periodontitis. Participants were selected from the patients who presented for periodontal treatment between March 2024 and August 2024 at Department of Periodontology, Faculty of Dentistry, Sivas Cumhuriyet University, Sivas, Turkey.
Who may be able to join
- Being between 20-50 years old
- Meeting the criteria for the working groups
Who cannot join
- having any systemic or metabolic diseases or insturition of effected bone metabolism,
- having bruksizm habits,
- pregnant or lactating,
- received periodontal/peri-implant treatment within the last 6 months,
- the history of antibiotics or antiinflamatuars use regularly within the last 6 months,
- having < 20 teeth (except for 3rd molars),
- smokers or consumed alcohol.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Non-surgical Periodontal Treatment on Gingival Crevicular Fluid Dickkoff-1(Dkk-1) and Secreted Frizzled Related Protein 5 (sFRP5) Levels
Periodontitis is a condition that is defined by microbial-associated, host-induced inflammation, which ultimately results in the loss of periodontal attachment.Periodontal clinical parameters are the most reliable indicators of periodontal disease; however, they provide information about past tissue destruction and are insufficient for predicting future periodontal disease activity. Therefore, evaluation of Dickkopf-1 (Dkk-1) and secreted Frizzled related protein 5 (sFRP5), which are Wnt signaling pathway antagonists, in periodontal inflammation may be a focus of interest. A total of 99 individuals, 44 male and 55 female, participated in our study and were divided into three groups as periodontally healthy, gingivitis and periodontitis. Non-surgical periodontal treatment was applied to the disease groups. Dkk-1 and sFRP5 were evaluated in gingival crevicular fluid (GCF) at the baseline and after periodontal treatment.
Read the detailed description
The participants were divided into three groups in accordance with their periodontal status according to the 2017 World Workshop on the classification of periodontal diseases : Periodontally healthy (group H, n = 33, probing depth (PD) ≤3 mm, fullmouth bleeding scores; bleeding on probing (BOP) % <10, no clinical attachment levels (CAL) and radiologic bone loss), gingivitis (group G, n = 33 PD ≤3 mm, % BOP >30, no CAL(due to periodontal disease) and radiologic bone loss), Stage 3 Grade B periodontitis (group P, n = 33, These individuals had a minimum of two non-adjacent teeth with sites with PD ≥6 mm, CAL ≥5 mm, BOP ≥30%, tooth loss due to periodontitis ≤4 teeth, the alveolar bone loss at radiographs extending to middle or apical third of the root, the presence of consistent amounts of plaque biofilm/calculus deposits commensurate with the severity of periodontal tissue breakdown, the proportion of percentage bone loss to age values were between 0.25 and 1). Panoromic and periapical radiographic examination was also performed for the diagnosis of periodontitis.
Periodontal status of each individual included in the study was determined by measuring plaque index (PI), gingival index (GI), PD, clinical attachment level (CAL) and bleeding of probing (BOP). PD and CAL were measured on six sites (mesio-buccal/ facial, mid-buccal/facial, disto-buccal/facial, mesio-lingual/palatinal, mid-lingual/palatinal, disto-lingual/palatinal) of the teeth in baseline and after periodontal treatment. Bleeding was observed up to 10 sec after the examination of probing depth and BOP score was calculated as the number of BOP-positive sites was divided the number of total sites, after multiplied with 100. Panoramic and periapical radiographs were used to determine the alveolar bone loss. All clinical measurements were recorded using a standard Williams periodontal probe.
Within 2 weeks from the screening visit, phase 1 periodontal treatment/scaling and root planing under local anesthesia using manual instruments and ultrasonic devices in a single appointment were performed and oral hygiene instructions were given to all participants with periodontitis by a single calibrated periodontist. In gingivitis and periodontally healthy groups, phase 1 periodontal treatment and oral hygiene education were given to each one. All periodontal clinical measurements recorded and gingival crevicular fluid (GCF) samples collection were at baseline and the 6-8 th week after the periodontal treatment in patients with G and P group and at one time point (baseline) in H group.
- Being tested
- Collection of gingival crevicular fluid, ELISA
- Keywords
- Dickkopf-1, secreted Frizzled Related Protein 5, Gingival crevicular fluid
- Medical subject headings
- Alveolar Bone Loss, Periodontal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Collection of gingival crevicular fluid, ELISADiagnostic test
GCF samples were collected at baseline and at the 6-8 -week follow-up appointment after non-surgical periodontal treatment . After removing the supragingival plaque from the interproximal surfaces with sterile curettes, these sample surfaces were isolated with cotton rolls and slightly air-dried to avoid contamination. Standardized paper strips were inserted 1 to 2 mm into the gingival sulcus and held for 30 seconds to collect GCF. Strips contaminated with blood or saliva were discarded and not evaluated. The paper strips were transferred to a precalibrated Periotron 8000 device to measure the fluid volume. Paper strips were placed in sterile Eppendorf tubes and stored at -80C, until laboratory analysis. The level of GCF Dkk-1 and sFRP5 levels was measured by ELISA using commercial kits.
| Study group | Role | What they receive |
|---|---|---|
| Periodontally Healthy | PD ≤3 mm, fullmouth bleeding scores (BOP) % <10, no CAL and radiologic bone loss Receives: Diagnostic Test: Collection of gingival crevicular fluid, ELISA | |
| Gingivitis | PD ≤3 mm, % BOP >30, no CAL(due to periodontal disease) and radiologic bone loss Receives: Diagnostic Test: Collection of gingival crevicular fluid, ELISA | |
| Periodontitis | These individuals had a minimum of two non-adjacent teeth with sites with PD ≥6 mm, CAL ≥5 mm, BOP ≥30%, tooth loss due to periodontitis ≤4 teeth, the alveolar bone loss at radiographs extending to middle or apical third of the root, the presence of consistent amounts of plaque biofilm/calculus deposits commensurate with the severity of periodontal tissue breakdown, the proportion of percentage bone loss to age values were between 0.25 and 1 Receives: Diagnostic Test: Collection of gingival crevicular fluid, ELISA |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dkk-1 and sFRP5 levels at baseline and after periodontal treatment
Dkk-1 and sFRP5 levels assessed by ELISA in GCF at baseline and after non-surgical periodontal treatment were the primary outcome measures.Dkk-1 and sFRP5 will be measured by ELISA technique according to the manufacturer's instructions. The sensitivity value for Dkk-1 and sFRP5 is 0.056 ng/mL and 0.059 ng/mL, respectively. Optical densities will be taken at 450 nm wavelength, and standard concentrations and corresponding optical density values and sample optical density values will be recorded. The standard curve will be drawn according to the optical densities and concentrations of standards, and the concentrations of all samples will be calculated by the linear regression equation of the obtained standard curve.Dkk-1 and sFRP5 total amount will be given in ng unit.
Measured: 6-8 weeks
Secondary outcomes (6)
Gingival Crevicular Fluid (GCF)Volume at baseline and after periodontal treatment
GCF volume will be obtained by converting the number measured on the periotron device (=periotron unit) into microliters. This value will be stated among the groups (H, G and P) and in the G and P groups after non-surgical periodontal treatment.
Measured: 6-8 weeks
Gingival index (GI) at baseline and after periodontal treatment
The plaque index (GI) (Löe \& Silness, 1963) of each individual included in the study was measured at six sites of the teeth (mesio-buccal/facial, mid-buccal/facial, disto-buccal/facial, mesio-lingual/palatinal, mid-lingual/palatinal, disto-lingual/palatinal) with a periodontal probe at baseline and after periodontal treatment (6-8 weeks) in G and P groups and recorded with a score between 0-3.
Measured: 6-8 weeks
Bleeding on probing (BOP) percentage at baseline and after periodontal treatment
Whether there is bleeding on probing will be determined by dividing the number of positive areas by the total number of areas and multiplying by 100. It will be stated as a percentage between the groups and within the groups after non-surgical periodontal treatment (G and P).
Measured: 6-8 weeks
Probing depth (PD)at baseline and after periodontal treatment
Pocket depth was recorded with the help of a periodontal probe at six sites of the teeth (mesio-buccal/facial, mid-buccal/facial, disto-buccal/facial, mesio-lingual/palatinal, mid-lingual/palatinal, disto-lingual/palatinal) at the beginning and after periodontal treatment, as the distance from the gingival margin to the periodontal pocket base in mm.
Measured: 6-8 weeks
Plaque index (PI) at baseline and after periodontal treatment
The plaque index (PI) (Silness \& Löe, 1964) of each individual included in the study was measured at six sites of the teeth (mesio-buccal/facial, mid-buccal/facial, disto-buccal/facial, mesio-lingual/palatinal, mid-lingual/palatinal, disto-lingual/palatinal) with a periodontal probe at baseline and after periodontal treatment (6-8 weeks) in G and P groups and recorded with a score between 0-3.
Measured: 6-8 weeks
Clinical attachment levels (CAL) at baseline and after periodontal treatment
Clinical attachment levels were recorded at baseline and after periodontal treatment in six regions of the teeth (mesio-buccal/facial, mid-buccal/facial, disto-buccal/facial, mesio-lingual/palatinal, mid-lingual/palatinal, disto-lingual/palatinal) using a periodontal probe, from the cementoenamel junction to the base of the periodontal pocket in mm.
Measured: 6-8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2024
- Study start1 Mar 2024
- Primary completion1 Nov 2024
- Study completion1 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Periodontal InflammationStudies 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
- 99 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cumhuriyet University
- Sponsor type
- University, hospital or other
- Collaborators
- Kırıkkale University
- Responsible party
- Principal investigator, Sukran Acipinar, Cumhuriyet University
- Investigators
- Şükran Acıpınar, Principal investigator, Cumhuriyet University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06727929
- Sponsor's protocol ID
- SCU
- Status last verified
- Mar 2026
- First submitted
- 4 Dec 2024
- Last updated
- 19 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: It will be updated and shared upon completion of the study.
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Non-surgical Periodontal Treatment on Gingival Crevicular Fluid Dickkoff-1(Dkk-1) and Secreted Frizzled Related Protein 5 (sFRP5) Levels
- ClinicalTrials.gov ID
- NCT06727929
- Acronym / sponsor ID
- SCU
- Keywords
- Dickkopf-1, secreted Frizzled Related Protein 5, Gingival crevicular fluid
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 99 participants (actual)
- Lead sponsor
- Cumhuriyet UniversityUniversity, hospital or other
- Collaborators
- Kırıkkale University
- Study start
- 1 Mar 2024 (actual)
- Primary completion
- 1 Nov 2024 (actual)
- Study completion
- 1 Jan 2025 (actual)
- First posted
- 11 Dec 2024 (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.
Periodontitis is a condition that is defined by microbial-associated, host-induced inflammation, which ultimately results in the loss of periodontal attachment.Periodontal clinical parameters are the most reliable indicators of periodontal disease; however, they provide information about past tissue destruction and are insufficient for predicting future periodontal disease activity. Therefore, evaluation of Dickkopf-1 (Dkk-1) and secreted Frizzled related protein 5 (sFRP5), which are Wnt signaling pathway antagonists, in periodontal inflammation may be a focus of interest. A total of 99 individuals, 44 male and 55 female, participated in our study and were divided into three groups as periodontally healthy, gingivitis and periodontitis. Non-surgical periodontal treatment was applied to the disease groups. Dkk-1 and sFRP5 were evaluated in gingival crevicular fluid (GCF) at the baseline and after periodontal treatment.
Detailed description
The participants were divided into three groups in accordance with their periodontal status according to the 2017 World Workshop on the classification of periodontal diseases : Periodontally healthy (group H, n = 33, probing depth (PD) ≤3 mm, fullmouth bleeding scores; bleeding on probing (BOP) % <10, no clinical attachment levels (CAL) and radiologic bone loss), gingivitis (group G, n = 33 PD ≤3 mm, % BOP >30, no CAL(due to periodontal disease) and radiologic bone loss), Stage 3 Grade B periodontitis (group P, n = 33, These individuals had a minimum of two non-adjacent teeth with sites with PD ≥6 mm, CAL ≥5 mm, BOP ≥30%, tooth loss due to periodontitis ≤4 teeth, the alveolar bone loss at radiographs extending to middle or apical third of the root, the presence of consistent amounts of plaque biofilm/calculus deposits commensurate with the severity of periodontal tissue breakdown, the proportion of percentage bone loss to age values were between 0.25 and 1). Panoromic and periapical radiographic examination was also performed for the diagnosis of periodontitis.
Periodontal status of each individual included in the study was determined by measuring plaque index (PI), gingival index (GI), PD, clinical attachment level (CAL) and bleeding of probing (BOP). PD and CAL were measured on six sites (mesio-buccal/ facial, mid-buccal/facial, disto-buccal/facial, mesio-lingual/palatinal, mid-lingual/palatinal, disto-lingual/palatinal) of the teeth in baseline and after periodontal treatment. Bleeding was observed up to 10 sec after the examination of probing depth and BOP score was calculated as the number of BOP-positive sites was divided the number of total sites, after multiplied with 100. Panoramic and periapical radiographs were used to determine the alveolar bone loss. All clinical measurements were recorded using a standard Williams periodontal probe.
Within 2 weeks from the screening visit, phase 1 periodontal treatment/scaling and root planing under local anesthesia using manual instruments and ultrasonic devices in a single appointment were performed and oral hygiene instructions were given to all participants with periodontitis by a single calibrated periodontist. In gingivitis and periodontally healthy groups, phase 1 periodontal treatment and oral hygiene education were given to each one. All periodontal clinical measurements recorded and gingival crevicular fluid (GCF) samples collection were at baseline and the 6-8 th week after the periodontal treatment in patients with G and P group and at one time point (baseline) in H group.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Periodontally Healthy | – | Diagnostic Test: Collection of gingival crevicular fluid, ELISAPD ≤3 mm, fullmouth bleeding scores (BOP) % <10, no CAL and radiologic bone loss |
| Gingivitis | – | Diagnostic Test: Collection of gingival crevicular fluid, ELISAPD ≤3 mm, % BOP >30, no CAL(due to periodontal disease) and radiologic bone loss |
| Periodontitis | – | Diagnostic Test: Collection of gingival crevicular fluid, ELISAThese individuals had a minimum of two non-adjacent teeth with sites with PD ≥6 mm, CAL ≥5 mm, BOP ≥30%, tooth loss due to periodontitis ≤4 teeth, the alveolar bone loss at radiographs extending to middle or apical third of the root, the presence of consistent amounts of plaque biofilm/calculus deposits commensurate with the severity of periodontal tissue breakdown, the proportion of percentage bone loss to age values were between 0.25 and 1 |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- A total of 99 patients (44 males and 55 females) between 20-50 years of age were included and were divided into three groups as follows: periodontally healthy, patients with gingivitis, and patients with stage 3 grade B periodontitis. Participants were selected from the patients who presented for periodontal treatment between March 2024 and August 2024 at Department of Periodontology, Faculty of Dentistry, Sivas Cumhuriyet University, Sivas, Turkey.
Key inclusion criteria (2 listed)
- Being between 20-50 years old
- Meeting the criteria for the working groups
Key exclusion criteria (7 listed)
- having any systemic or metabolic diseases or insturition of effected bone metabolism,
- having bruksizm habits,
- pregnant or lactating,
- received periodontal/peri-implant treatment within the last 6 months,
- the history of antibiotics or antiinflamatuars use regularly within the last 6 months,
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 |
|---|---|---|
| Collection of gingival crevicular fluid, ELISAGCF samples were collected at baseline and at the 6-8 -week follow-up appointment after non-surgical periodontal treatment . After removing the supragingival plaque from the interproximal surfaces with sterile curettes, these sample surfaces were isolated with cotton rolls and slightly air-dried to avoid contamination. Standardized paper strips were inserted 1 to 2 mm into the gingival sulcus and held for 30 seconds to collect GCF. Strips contaminated with blood or saliva were discarded and not evaluated. The paper strips were transferred to a precalibrated Periotron 8000 device to measure the fluid volume. Paper strips were placed in sterile Eppendorf tubes and stored at -80C, until laboratory analysis. The level of GCF Dkk-1 and sFRP5 levels was measured by ELISA using commercial kits. | Diagnostic test | Gingivitis, Periodontally Healthy, Periodontitis |
Primary outcome
Dkk-1 and sFRP5 levels at baseline and after periodontal treatment
Time frame: 6-8 weeks
Dkk-1 and sFRP5 levels assessed by ELISA in GCF at baseline and after non-surgical periodontal treatment were the primary outcome measures.Dkk-1 and sFRP5 will be measured by ELISA technique according to the manufacturer's instructions. The sensitivity value for Dkk-1 and sFRP5 is 0.056 ng/mL and 0.059 ng/mL, respectively. Optical densities will be taken at 450 nm wavelength, and standard concentrations and corresponding optical density values and sample optical density values will be recorded. The standard curve will be drawn according to the optical densities and concentrations of standards, and the concentrations of all samples will be calculated by the linear regression equation of the obtained standard curve.Dkk-1 and sFRP5 total amount will be given in ng unit.
6 secondary outcomes
Gingival Crevicular Fluid (GCF)Volume at baseline and after periodontal treatment
Time frame: 6-8 weeks
Gingival index (GI) at baseline and after periodontal treatment
Time frame: 6-8 weeks
Bleeding on probing (BOP) percentage at baseline and after periodontal treatment
Time frame: 6-8 weeks
Probing depth (PD)at baseline and after periodontal treatment
Time frame: 6-8 weeks
Plaque index (PI) at baseline and after periodontal treatment
Time frame: 6-8 weeks
Clinical attachment levels (CAL) at baseline and after periodontal treatment
Time frame: 6-8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2026.
- Individual participant dataSharing planned: No. It will be updated and shared upon completion of the study.
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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. This study is not recruiting at the moment.
Şükran Acıpınar principal investigator
Cumhuriyet University
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 Periodontal Inflammation and Alveolar Bone Loss, run by Cumhuriyet 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 2 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: finished, as of the sponsor's last update on 19 Mar 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dkk-1 and sFRP5 levels at baseline and after periodontal treatment (time frame: 6-8 weeks). 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 19 Mar 2026.