Periodontitis (Stage 3)NCT06687005
Comparative Analysis of Gremlin-1, Syndecan-4 and IL-1 Beta Levels in Gingival Crevicular Fluid Among İndividuals With Periodontal Health and Stage III Periodontitis, Considering Both Smokers and Non-Smokers, Before and After Non-Surgical Periodontal Therapy
An observational study of Periodontitis (Stage 3) and Gremlin-1, run by Tugba Aydin at 1 site in Turkey (Türkiye).
Trial summary
eriodontitis is a complex disease characterized by the inflammation and destruction of the tissues supporting the teeth, and smoking can adversely affect the pathophysiological changes in this process. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Periodontitis (Stage 3), Gremlin-1, Syndecan 4
- What is being tested?
- non-surgical periodontal therapy
- Type of treatment
- Surgery or procedure
- How many people
- 45 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Apr 2024to 15 Dec 2024
- How long will I take part?
- 3 Months
- 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 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: This study will include a total of 45 volunteer individuals, consisting of 15 smokers and 15 non-smokers diagnosed with stage 3 periodontitis, aged 18-60, who seek treatment for periodontal complaints such as pain, sensitivity, and gum recession at the Department of Periodontology, Faculty of Dentistry, Atatürk University, as well as 15 healthy individuals. The sampling procedure will be carried out at the Department of Periodontology, Faculty of Dentistry, Atatürk University, with the approval of the ethical committee report from the Scientific Research Ethics Committee of Erzurum Medical Faculty.
Who may be able to join
- The volunteers must not have any systemic diseases.
- The volunteers must be between 18 and 60 years of age.
- Control group: Periodontally healthy patients with no signs of periodontal disease and no history of smoking.
- Study Group I: Non-smoking patients with stage III periodontitis, evaluated based on clinical findings such as PD ≥ 5 mm and CAL ≥ 4 mm (with ≥ 30% of affected teeth), without radiographic evidence of bone loss and a history of smoking.
- Study Group II: Smoking patients with untreated stage III periodontitis, evaluated based on clinical findings such as PD ≥ 5 mm and CAL ≥ 4 mm (with ≥ 30% of affected teeth), with radiographic evidence of bone loss and a history of smoking for at least 10 cigarettes per day over the past 3 years.
Who cannot join
- The individual's unwillingness to participate in the study
- Being outside the specified age range
- Pregnant or breastfeeding patients
- Having a systemic disease
- Smoking in the past 10 years
- Having received periodontal treatment within the last 6 months
Trial locations and contacts
1 site in 1 country.
About this study
eriodontitis is a complex disease characterized by the inflammation and destruction of the tissues supporting the teeth, and smoking can adversely affect the pathophysiological changes in this process. In an unhealthy periodontium, the host's inflammatory response products can be detected in the content of DOS, and the presence of these components is crucial in obtaining information about the pathogenesis of periodontal disease. Biochemical markers found in DOS are significantly helpful in determining the active stages and regions of the disease and in evaluating the host response to periodontal treatment. IL-1β has been determined to play a leading role in the pathogenic mechanism of periodontal tissue destruction, and the degree of inflammation in the tissues can be measured by IL-1β activity in DOS. Syndecan-4, a member of the transmembrane heparan sulfate proteoglycan family, regulates cellular activities such as tissue homeostasis, inflammation, fibrosis, and tumor metastasis. Gremlin-1 is a protein that inhibits BMP (Bone Morphogenetic Protein) signaling, influencing cell growth and tissue development. Gremlin-1 plays an important role in tissue repair and regeneration, modulating inflammatory processes and regulating cellular homeostasis. While recent studies have explained the role of Syndecan-4 and Gremlin-1 in inflammation, their effects on periodontal tissues are still quite limited in the literature. Our study aims to investigate the effects of smoking on these biomarkers by comparing the periodontal status before and after treatment of healthy, smoking, and non-smoking individuals with stage 3 periodontitis, with the goal of developing early diagnostic tools in the future.
Read the detailed description
Periodontal diseases are inflammatory conditions that affect a significant portion of the global population. The cleaning of supragingival and subgingival dental calculus and flap surgery when necessary are treatment options. If left untreated, they lead to the loss of teeth and the supporting tissues. Numerous bacterial species colonize the oral cavity and can alter the delicate balance between the host and bacteria in the development of periodontal disease. While it begins with subgingival microbial plaque, the origin of periodontitis is based on the tissue destruction mediators produced by the host response to pathogenic infections. Periodontitis is classified into stages and grades according to the severity and progression of the disease. In stage III periodontitis, significant interdental clinical attachment loss (CAL) is observed, and in the absence of treatment, tooth loss may occur. This stage is characterized by bone destruction extending to the middle of the tooth root, bone intrabony pockets, and periodontal lesions. Class II or III furcation involvement may also be observed. To diagnose a patient with stage III periodontitis, the interdental CAL must be greater than 5 mm, the tooth loss due to periodontitis should be fewer than four teeth, and the probing pocket depth (PPD) should be ≥6 mm, with at least 3 mm vertical bone loss. The goal of periodontal treatment is to maintain and restore the health of the tissues surrounding and supporting the teeth. Due to the accumulation of cement, plaque, and calculus within the periodontal pocket, the surface becomes contaminated by bacteria and enzymes. Nonsurgical periodontal therapy is a frequently used method for the treatment of periodontitis. The main aim is to remove microbial biofilm from the diseased root surface without surgical intervention and without removing the surrounding soft tissue. In this way, the diseased root surface is biologically compatible, supporting the reattachment of periodontal tissues to the tooth. The analysis of Gingival Crevicular Fluid (GCF) is a sensitive diagnostic approach in studying the host's activity in periodontal diseases. In an unhealthy periodontium, the host's inflammatory response products can be detected in the content of GCF, and the presence of these components is crucial for obtaining information about the pathogenesis of periodontal disease. Biochemical evaluation of GCF is important not only for the early detection of periodontal disease but also for showing associations with connective tissue destruction products and bone metabolism. The biochemical markers in GCF are significantly helpful in determining the active stages and regions of the disease and in evaluating the host response to periodontal treatment. IL-1β plays a pioneering role in the pathogenic mechanism of periodontal tissue destruction. The severity of periodontal disease can be determined by the activity of this cytokine. According to studies, clinical parameters such as Gingival Index (GI) and Probing Pocket Depth (PPD) are correlated with IL-1β activity in GCF. The intensity of inflammation in periodontal tissues can be measured by IL-1β activity in GCF. Smoking has been shown in studies to have negative effects on oral health, as it does on general health. In individuals who smoke, periodontal diseases tend to be more common and severe. Smoking has been shown to increase inflammation in periodontal tissues, negatively affect tissue healing, and suppress the immune system. In this context, the effects of smoking on the treatment outcomes of patients with periodontitis should be studied in detail. Syndecan-4, a member of the transmembrane heparan sulfate proteoglycan family, binds to extracellular effector molecules and regulates cellular processes such as tissue homeostasis, inflammation, fibrosis, and tumor metastasis. Due to its ability to regulate cell adhesion, modulate signal transduction, and influence cell migration, Syndecan-4 plays a critical role in cell behavior and tissue organization. Gremlin-1, one of the antagonists of bone morphogenetic proteins (BMPs), contains a cysteine knot and is a member of the cysteine knot superfamily. Gremlin-1 is a protein that inhibits BMP signaling and is a factor influencing cell growth and tissue development. Gremlin-1 plays an important role in tissue repair and regeneration, modulating inflammation processes and regulating cellular homeostasis. The changes in Syndecan-4 levels and their impact on periodontal health under smoking and periodontitis conditions should be studied to better understand the role of this molecule in periodontal disease. Understanding how Gremlin-1 levels change in patients with periodontitis and smokers can contribute to a better understanding of periodontal health and the development of more effective treatment strategies. In the planned study, the changes in the levels of Gremlin-1, Syndecan-4, and IL-1β in periodontitis, a significant disease of oral and dental health, will be investigated to provide new information to the literature.
- Conditions
- Periodontitis (Stage 3), Gremlin-1, Syndecan 4, Interleukin 1-beta
- Being tested
- non-surgical periodontal therapy
- Medical subject headings
- 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.
non-surgical periodontal therapyProcedure or surgery
non-surgical periodontal therapy
| Study group | Role | What they receive |
|---|---|---|
| Smokers with stage 3 periodontitis | Not described Receives: Procedure: non-surgical periodontal therapy | |
| Non-smokers with stage 3 periodontitis | Not described Receives: Procedure: non-surgical periodontal therapy | |
| Healthy Participant | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
assesment of Gremlin-1 pre-treatment
Measurement of Gremlin-1 levels using an ELISA kit from gingival crevicular fluid samples taken from patients before periodontitis treatment.
Measured: From enrollment to the end of treatment at 3 months
assesment of syndecan-4 pre treatment
Measurement of Syndecan-4- levels using an ELISA kit from gingival crevicular fluid samples taken from patients before periodontitis treatment.
Measured: From enrollment to the end of treatment at 3 months
Assesment of IL-1 Beta pre-treatment
Measurement of IL-1 Beta levels using an ELISA kit from gingival crevicular fluid samples taken from patients before periodontitis treatment.
Measured: From enrollment to the end of treatment at 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2024
- Study start1 Apr 2024
- Primary completion15 Dec 2024 (estimated)
- Study completion15 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Periodontitis (Stage 3)Studies 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
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 45 participants (actual)
- Target duration
- 3 Months
Sponsor and investigators
- Lead sponsor
- Tugba Aydin
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Tugba Aydin, Ataturk University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06687005
- Sponsor's protocol ID
- 2024/01-16
- Status last verified
- Nov 2024
- First submitted
- 12 Nov 2024
- Last updated
- 13 Nov 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Analysis of Gremlin-1, Syndecan-4 and IL-1 Beta Levels in Gingival Crevicular Fluid Among İndividuals With Periodontal Health and Stage III Periodontitis, Considering Both Smokers and Non-Smokers, Before and After Non-Surgical Periodontal Therapy
- ClinicalTrials.gov ID
- NCT06687005
- Acronym / sponsor ID
- 2024/01-16
- Conditions
- Periodontitis (Stage 3), Gremlin-1, Syndecan 4, Interleukin 1-beta
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Tugba AydinUniversity, hospital or other
- Study start
- 1 Apr 2024 (actual)
- Primary completion
- 15 Dec 2024 (estimated)
- Study completion
- 15 Dec 2024 (estimated)
- First posted
- 13 Nov 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.
eriodontitis is a complex disease characterized by the inflammation and destruction of the tissues supporting the teeth, and smoking can adversely affect the pathophysiological changes in this process. In an unhealthy periodontium, the host's inflammatory response products can be detected in the content of DOS, and the presence of these components is crucial in obtaining information about the pathogenesis of periodontal disease. Biochemical markers found in DOS are significantly helpful in determining the active stages and regions of the disease and in evaluating the host response to periodontal treatment. IL-1β has been determined to play a leading role in the pathogenic mechanism of periodontal tissue destruction, and the degree of inflammation in the tissues can be measured by IL-1β activity in DOS. Syndecan-4, a member of the transmembrane heparan sulfate proteoglycan family, regulates cellular activities such as tissue homeostasis, inflammation, fibrosis, and tumor metastasis. Gremlin-1 is a protein that inhibits BMP (Bone Morphogenetic Protein) signaling, influencing cell growth and tissue development. Gremlin-1 plays an important role in tissue repair and regeneration, modulating inflammatory processes and regulating cellular homeostasis. While recent studies have explained the role of Syndecan-4 and Gremlin-1 in inflammation, their effects on periodontal tissues are still quite limited in the literature. Our study aims to investigate the effects of smoking on these biomarkers by comparing the periodontal status before and after treatment of healthy, smoking, and non-smoking individuals with stage 3 periodontitis, with the goal of developing early diagnostic tools in the future.
Detailed description
Periodontal diseases are inflammatory conditions that affect a significant portion of the global population. The cleaning of supragingival and subgingival dental calculus and flap surgery when necessary are treatment options. If left untreated, they lead to the loss of teeth and the supporting tissues. Numerous bacterial species colonize the oral cavity and can alter the delicate balance between the host and bacteria in the development of periodontal disease. While it begins with subgingival microbial plaque, the origin of periodontitis is based on the tissue destruction mediators produced by the host response to pathogenic infections. Periodontitis is classified into stages and grades according to the severity and progression of the disease. In stage III periodontitis, significant interdental clinical attachment loss (CAL) is observed, and in the absence of treatment, tooth loss may occur. This stage is characterized by bone destruction extending to the middle of the tooth root, bone intrabony pockets, and periodontal lesions. Class II or III furcation involvement may also be observed. To diagnose a patient with stage III periodontitis, the interdental CAL must be greater than 5 mm, the tooth loss due to periodontitis should be fewer than four teeth, and the probing pocket depth (PPD) should be ≥6 mm, with at least 3 mm vertical bone loss. The goal of periodontal treatment is to maintain and restore the health of the tissues surrounding and supporting the teeth. Due to the accumulation of cement, plaque, and calculus within the periodontal pocket, the surface becomes contaminated by bacteria and enzymes. Nonsurgical periodontal therapy is a frequently used method for the treatment of periodontitis. The main aim is to remove microbial biofilm from the diseased root surface without surgical intervention and without removing the surrounding soft tissue. In this way, the diseased root surface is biologically compatible, supporting the reattachment of periodontal tissues to the tooth. The analysis of Gingival Crevicular Fluid (GCF) is a sensitive diagnostic approach in studying the host's activity in periodontal diseases. In an unhealthy periodontium, the host's inflammatory response products can be detected in the content of GCF, and the presence of these components is crucial for obtaining information about the pathogenesis of periodontal disease. Biochemical evaluation of GCF is important not only for the early detection of periodontal disease but also for showing associations with connective tissue destruction products and bone metabolism. The biochemical markers in GCF are significantly helpful in determining the active stages and regions of the disease and in evaluating the host response to periodontal treatment. IL-1β plays a pioneering role in the pathogenic mechanism of periodontal tissue destruction. The severity of periodontal disease can be determined by the activity of this cytokine. According to studies, clinical parameters such as Gingival Index (GI) and Probing Pocket Depth (PPD) are correlated with IL-1β activity in GCF. The intensity of inflammation in periodontal tissues can be measured by IL-1β activity in GCF. Smoking has been shown in studies to have negative effects on oral health, as it does on general health. In individuals who smoke, periodontal diseases tend to be more common and severe. Smoking has been shown to increase inflammation in periodontal tissues, negatively affect tissue healing, and suppress the immune system. In this context, the effects of smoking on the treatment outcomes of patients with periodontitis should be studied in detail. Syndecan-4, a member of the transmembrane heparan sulfate proteoglycan family, binds to extracellular effector molecules and regulates cellular processes such as tissue homeostasis, inflammation, fibrosis, and tumor metastasis. Due to its ability to regulate cell adhesion, modulate signal transduction, and influence cell migration, Syndecan-4 plays a critical role in cell behavior and tissue organization. Gremlin-1, one of the antagonists of bone morphogenetic proteins (BMPs), contains a cysteine knot and is a member of the cysteine knot superfamily. Gremlin-1 is a protein that inhibits BMP signaling and is a factor influencing cell growth and tissue development. Gremlin-1 plays an important role in tissue repair and regeneration, modulating inflammation processes and regulating cellular homeostasis. The changes in Syndecan-4 levels and their impact on periodontal health under smoking and periodontitis conditions should be studied to better understand the role of this molecule in periodontal disease. Understanding how Gremlin-1 levels change in patients with periodontitis and smokers can contribute to a better understanding of periodontal health and the development of more effective treatment strategies. In the planned study, the changes in the levels of Gremlin-1, Syndecan-4, and IL-1β in periodontitis, a significant disease of oral and dental health, will be investigated to provide new information to the literature.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Target follow-up
- 3 Months
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Smokers with stage 3 periodontitis | – | Procedure: non-surgical periodontal therapy |
| Non-smokers with stage 3 periodontitis | – | Procedure: non-surgical periodontal therapy |
| Healthy Participant | – | – |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- This study will include a total of 45 volunteer individuals, consisting of 15 smokers and 15 non-smokers diagnosed with stage 3 periodontitis, aged 18-60, who seek treatment for periodontal complaints such as pain, sensitivity, and gum recession at the Department of Periodontology, Faculty of Dentistry, Atatürk University, as well as 15 healthy individuals. The sampling procedure will be carried out at the Department of Periodontology, Faculty of Dentistry, Atatürk University, with the approval of the ethical committee report from the Scientific Research Ethics Committee of Erzurum Medical Faculty.
Key inclusion criteria (5 listed)
- The volunteers must not have any systemic diseases.
- The volunteers must be between 18 and 60 years of age.
- Control group: Periodontally healthy patients with no signs of periodontal disease and no history of smoking.
- Study Group I: Non-smoking patients with stage III periodontitis, evaluated based on clinical findings such as PD ≥ 5 mm and CAL ≥ 4 mm (with ≥ 30% of affected teeth), without radiographic evidence of bone loss and a history of smoking.
- Study Group II: Smoking patients with untreated stage III periodontitis, evaluated based on clinical findings such as PD ≥ 5 mm and CAL ≥ 4 mm (with ≥ 30% of affected teeth), with radiographic evidence of bone loss and a history of smoking for at least 10 cigarettes per day over the past 3 years.
Key exclusion criteria (6 listed)
- The individual's unwillingness to participate in the study
- Being outside the specified age range
- Pregnant or breastfeeding patients
- Having a systemic disease
- Smoking in the past 10 years
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 |
|---|---|---|
| non-surgical periodontal therapynon-surgical periodontal therapy | Procedure or surgery | Non-smokers with stage 3 periodontitis, Smokers with stage 3 periodontitis |
Primary outcome
assesment of Gremlin-1 pre-treatment
Time frame: From enrollment to the end of treatment at 3 months
Measurement of Gremlin-1 levels using an ELISA kit from gingival crevicular fluid samples taken from patients before periodontitis treatment.
assesment of syndecan-4 pre treatment
Time frame: From enrollment to the end of treatment at 3 months
Measurement of Syndecan-4- levels using an ELISA kit from gingival crevicular fluid samples taken from patients before periodontitis treatment.
Assesment of IL-1 Beta pre-treatment
Time frame: From enrollment to the end of treatment at 3 months
Measurement of IL-1 Beta levels using an ELISA kit from gingival crevicular fluid samples taken from patients before periodontitis treatment.
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 13 Nov 2024.
- Individual participant dataSharing planned: Yes
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Periodontitis (Stage 3) and Gremlin-1, run by Tugba Aydin 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 5 inclusion and 6 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: under way, not looking for participants, as of the sponsor's last update on 13 Nov 2024. 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?
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?
assesment of Gremlin-1 pre-treatment (time frame: From enrollment to the end of treatment at 3 months). The study lists 3 primary outcomes in all. 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 13 Nov 2024.