Periodontal DiseasesNCT04407026
Oral and Systemic Levels of TFF-1 and TTF-3 in Periodontal Diseases
An observational study of Periodontal Diseases, run by Aydin Adnan Menderes University at 1 site in Turkey (Türkiye).
Trial summary
Trefoil factor family (TFF) consists of a group of small peptides that have key roles in host immune response and repair of tissue damage. Interleukin (IL)-1β is a regulatory proinflammatory cytokine in periodontal inflammation. Read more about this study
- Who is it for?
- Ages 25 to 49 years
- Conditions the study is for
- Periodontal Diseases
- What is being tested?
- biofluids
- How many people
- 100 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jul 2017to 1 Apr 2018
- 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 25 to 49 years
- All sexes
- Adult
Study population: Healthy controls included volunteers with clinically healthy periodontium who had BOP < 10% and PD ≤ 3 mm, no sites with attachment loss or radiographic sign of alveolar bone destruction. Gingivitis patients showed PD ≤ 3 mm with BOP > 50% in the entire mouth as well as no clinical attachment loss or alveolar bone loss. Periodontitis patients (Stage 3) had PD ≥ 6 mm, interdental CAL ≥ 5 mm affecting 30% of the teeth or more and showed radiographic bone loss. They showed also no more than 4 teeth loss due to periodontitis.
Who may be able to join
- Systemically healthy individuals
- No history of smoking
- Individuals between the ages of 25-50 years
- Having at least 20 natural teeth
Who cannot join
- Any systemic disorders (i.e. diabetes mellitus, cardiovascular diseases, rheumatoid arthritis, immunological disorders, collagen-metabolic diseases, cancer)
- A history of smoking
- Pregnancy or lactation
- A history of surgical/non-surgical periodontal therapy in the past 1 year
- Drug therapy (e.g. anti-inflammatory, antibiotic treatment or any other pharmacological treatment) in the previous 6 months
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Two Novel Peptides Associated With Stage 3 Periodontitis: TFF-1 and TFF-3
Trefoil factor family (TFF) consists of a group of small peptides that have key roles in host immune response and repair of tissue damage. Interleukin (IL)-1β is a regulatory proinflammatory cytokine in periodontal inflammation. This study aimed to investigate the levels of TFF-1, TFF-3 and IL-1β in gingival crevicular fluid (GCF), saliva and serum of patients with gingivitis, stage 3 periodontitis and healthy individuals.
Read the detailed description
A total of one hundred participants were enrolled for the study. All individuals were assessed clinically and radiographically. Full-mouth clinical periodontal examinations were performed by the measurements of probing depth (PD), clinical attachment level (CAL), gingival index (GI), plaque index (PI) and bleeding on probing (BOP). All these measurements were recorded at six sites around each tooth with a manual periodontal probe. The participants were categorized into three groups: healthy controls (n=25), patients with gingivitis (n=25) and patients with periodontitis (n=50). Gingival crevicular fluid, saliva and serum samples were collected from each participant one day after the clinical periodontal measurements. TFF-1, TFF-3 and IL-1β levels of these biofluids were determined using the enzyme-linked immunosorbent assay.
- Conditions
- Periodontal Diseases
- Being tested
- biofluids
- Medical subject headings
- Periodontal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
biofluidsBiological
Gingival crevicular fluid, saliva and serum samples were obtained.
| Study group | Role | What they receive |
|---|---|---|
| Healthy | Healthy control group (n=25) consisted of the volunteers having clinically healthy gingiva, PD≤3 mm, BOP<10% and no sign of clinical attachment loss and radiographic alveolar bone destruction. Receives: Biological: biofluids | |
| Gingivitis | Gingivitis group (n=25) had PD≤3 mm with BOP>50% in the entire mouth, and no clinical attachment loss or alveolar bone loss. Receives: Biological: biofluids | |
| Stage 3 periodontitis | Stage 3 periodontitis group included the patients exhibiting PD ≥6 mm and interdental CAL ≥5 mm at %30 or more teeth. They had no more than four teeth loss. Receives: Biological: biofluids |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gingival crevicular fluid, saliva and serum TFF-1 and TFF-3 levels
Gingival crevicular fluid, saliva and serum TFF-1 and TFF-3 levels of gingivitis and periodontitis patients as well as healthy individuals were analyzed to identify the potential role of these peptides in periodontal diseases.
Measured: one day after the clinical periodontal measurements
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2020
- Study start1 Jul 2017
- Primary completion1 Mar 2018
- Study completion1 Apr 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Periodontal DiseasesStudies of the same condition, open and under way.
- More trials run by Aydin Adnan Menderes UniversityThe sponsor's other registered studies.
- 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
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aydin Adnan Menderes University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zeynep Pinar KELES YUCEL, Giresun University
- Investigators
- Zeynep Pinar Keles Yucel, Principal investigator, Giresun University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04407026
- Sponsor's protocol ID
- 2017/009
- Status last verified
- May 2020
- First submitted
- 25 May 2020
- Last updated
- 29 May 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Two Novel Peptides Associated With Stage 3 Periodontitis: TFF-1 and TFF-3
- ClinicalTrials.gov ID
- NCT04407026
- Acronym / sponsor ID
- 2017/009
- Conditions
- Periodontal Diseases
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Aydin Adnan Menderes UniversityUniversity, hospital or other
- Study start
- 1 Jul 2017 (actual)
- Primary completion
- 1 Mar 2018 (actual)
- Study completion
- 1 Apr 2018 (actual)
- First posted
- 29 May 2020 (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.
Trefoil factor family (TFF) consists of a group of small peptides that have key roles in host immune response and repair of tissue damage. Interleukin (IL)-1β is a regulatory proinflammatory cytokine in periodontal inflammation. This study aimed to investigate the levels of TFF-1, TFF-3 and IL-1β in gingival crevicular fluid (GCF), saliva and serum of patients with gingivitis, stage 3 periodontitis and healthy individuals.
Detailed description
A total of one hundred participants were enrolled for the study. All individuals were assessed clinically and radiographically. Full-mouth clinical periodontal examinations were performed by the measurements of probing depth (PD), clinical attachment level (CAL), gingival index (GI), plaque index (PI) and bleeding on probing (BOP). All these measurements were recorded at six sites around each tooth with a manual periodontal probe. The participants were categorized into three groups: healthy controls (n=25), patients with gingivitis (n=25) and patients with periodontitis (n=50). Gingival crevicular fluid, saliva and serum samples were collected from each participant one day after the clinical periodontal measurements. TFF-1, TFF-3 and IL-1β levels of these biofluids were determined using the enzyme-linked immunosorbent assay.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Healthy | – | Biological: biofluidsHealthy control group (n=25) consisted of the volunteers having clinically healthy gingiva, PD≤3 mm, BOP<10% and no sign of clinical attachment loss and radiographic alveolar bone destruction. |
| Gingivitis | – | Biological: biofluidsGingivitis group (n=25) had PD≤3 mm with BOP>50% in the entire mouth, and no clinical attachment loss or alveolar bone loss. |
| Stage 3 periodontitis | – | Biological: biofluidsStage 3 periodontitis group included the patients exhibiting PD ≥6 mm and interdental CAL ≥5 mm at %30 or more teeth. They had no more than four teeth loss. |
Who may qualify
- Ages
- 25 to 49 years
- Sex
- All
- Age groups
- Adult
- Study population
- Healthy controls included volunteers with clinically healthy periodontium who had BOP < 10% and PD ≤ 3 mm, no sites with attachment loss or radiographic sign of alveolar bone destruction. Gingivitis patients showed PD ≤ 3 mm with BOP > 50% in the entire mouth as well as no clinical attachment loss or alveolar bone loss. Periodontitis patients (Stage 3) had PD ≥ 6 mm, interdental CAL ≥ 5 mm affecting 30% of the teeth or more and showed radiographic bone loss. They showed also no more than 4 teeth loss due to periodontitis.
Key inclusion criteria (4 listed)
- Systemically healthy individuals
- No history of smoking
- Individuals between the ages of 25-50 years
- Having at least 20 natural teeth
Key exclusion criteria (5 listed)
- Any systemic disorders (i.e. diabetes mellitus, cardiovascular diseases, rheumatoid arthritis, immunological disorders, collagen-metabolic diseases, cancer)
- A history of smoking
- Pregnancy or lactation
- A history of surgical/non-surgical periodontal therapy in the past 1 year
- Drug therapy (e.g. anti-inflammatory, antibiotic treatment or any other pharmacological treatment) in the previous 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 |
|---|---|---|
| biofluidsGingival crevicular fluid, saliva and serum samples were obtained. | Biological | Gingivitis, Healthy, Stage 3 periodontitis |
Primary outcome
Gingival crevicular fluid, saliva and serum TFF-1 and TFF-3 levels
Time frame: one day after the clinical periodontal measurements
Gingival crevicular fluid, saliva and serum TFF-1 and TFF-3 levels of gingivitis and periodontitis patients as well as healthy individuals were analyzed to identify the potential role of these peptides in periodontal diseases.
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 29 May 2020.
- Individual participant dataSharing planned: No
Related trials for Periodontal Diseases
Not yet recruitingObservational study
Periodontal Status and Biomarkers in MASLD
Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD)
Recruiting
Thermosensitive Hyaluronic Gel With Octenidine as an Adjunctive to Subgingival Instrumentation
Periodontal Disease
Active, not recruitingObservational study
A Retrospective Comparative Evaluation of Omega-3 and Resveratrol Supplementation in Patients With Periodontitis
Periodontitis
Recruiting
Effects of Different Activation Techniques on Antimicrobial Photodynamic Therapy in Apical Periodontitis
Apical Periodontitis, Endodontic Retreatment
Recruiting
Ozone Gel Versus Chlorohexidine Gel as an Adjunct to Non-Surgical Treatment of Stage II Periodontitis Grade B Among Smokers Patients
Ozone Gel, Chlorohexidine Gel
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.
Zeynep Pinar Keles Yucel principal investigator
Giresun 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 Diseases, run by Aydin Adnan Menderes 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 4 inclusion and 5 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 29 May 2020. 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?
Gingival crevicular fluid, saliva and serum TFF-1 and TFF-3 levels (time frame: one day after the clinical periodontal measurements). 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 29 May 2020.