PeriodontitisNCT06110221
Activin-A and Interleukin-1β Levels in Periodontitis
An observational study of Periodontitis and Gingivitis, run by Aydin Adnan Menderes University at 1 site in Turkey (Türkiye).
Trial summary
Activin-A belongs to the transforming growth factor-beta superfamily and is a multifunctional cytokine that plays a role in inflammation, immune response, tissue repair and regeneration. Proinflammatory cytokine interleukin-1beta (IL-1β) can increase Activin-A expression in various cell types. Read more about this study
- Who is it for?
- Ages 27 to 48 yearsHealthy volunteers can take part
- Conditions the study is for
- Periodontitis, Gingivitis, Periodontal Health
- What is being tested?
- Periodontal clinical measurements, GCF and saliva sampling
- How many people
- 75 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 22 Mar 2019to 2 Feb 2020
- How long will I take part?
- 1 Day
- 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 27 to 48 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: This prospective case-control study consecutively enrolled 75 individuals (39 females and 36 males and; aged 27 to 48 years; mean age, 37.30 ± 5.10 years) from the Department of Periodontology, School of Dentistry, Aydın Adnan Menderes University, Aydın, Turkey, in the period from March 2019 to January 2020.
Who may be able to join
- the presence of no history of smoking (determined by self-reporting)
- at least 18 natural teeth excluding 3rd molars.
Who cannot join
- the presence of systemic conditions (diabetes mellitus, rheumatoid arthritis, cardiovascular system diseases, endocrine, immunologic, and mucocutaneous disorders) - use of antibiotics, antihypertensives immunosuppressive and anti-inflammatory drugs within the past 6 months and topical antiseptic solutions in the last 3 months
- having periodontal treatment in the previous year
- wearing removable partial dentures or orthodontic appliances
- restorative and endodontic therapy requirements
- pregnant or nursing women.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Oral Biofluid Levels of Activin-A and Interleukin-1 Beta Levels in Periodontal Health and Disease
Activin-A belongs to the transforming growth factor-beta superfamily and is a multifunctional cytokine that plays a role in inflammation, immune response, tissue repair and regeneration. Proinflammatory cytokine interleukin-1beta (IL-1β) can increase Activin-A expression in various cell types. This study aims to evaluate gingival crevicular fluid (GCF) and salivary Activin-A and IL-β levels in stage III periodontitis. Seventy-five systemically healthy and non-smoker volunteers consisting of 23 stage III periodontitis, 26 gingivitis and 26 periodontally healthy were enrolled. Full-mouth clinical periodontal indices were recorded, unstimulated whole saliva and GCF samples were obtained, Activin-A and IL-1β total amounts were determined by enzyme-linked immunosorbent assay. Statistical comparisons were performed using non-parametric tests.
Read the detailed description
Participants were divided into three groups according to the diagnostic criteria proposed by the Classification of Periodontal and Peri-implant Diseases and Conditions; I. Periodontitis group (n=23), II. Gingivitis group (n=26) III. Periodontally healthy group (n=26)
Clinical periodontal indices included probing depth (PD), clinical attachment loss (CAL), the dichotomous scoring of bleeding on probing (BOP +/-), gingival index (GI), and plaque index (PI). Clinical recordings were performed at six points (mesiobuccal, buccal, distobuccal, mesiopalatal/mesiolingual, palatal/lingual, and distopalatal/distolingual) of all teeth, except the 3rd molars, by a single investigator using a conventional periodontal probe.
Interproximal radiographic bone loss on the digital panoramic radiographs were evaluated, as the ratio of the distance between the bone crest and the cemento-enamel junction to the length of the root.
GCF and unstimulated whole saliva samples were obtained 1 day following the clinical periodontal measurements. Immediately after saliva collection, GCF was collected from the buccal aspects of non-contiguous interproximal sites in two single-rooted teeth via steril paper strips. Fluid samples were obtained from two deepest pockets in periodontitis group and the most inflamed sites with clinical signs of redness or edema in gingivitis group. In the periodontally healthy groups, samples were taken from the sites without visible inflammation. All samples were stored at -80 °C until further analysis.
Measurement of Activin-A and IL-1β levels in GCF and saliva samples were performed by the commercially available enzyme-linked immunosorbent assay (ELISA) kits. While GCF cytokine levels were expressed as both total amounts at two samples per 30 s and concentrations, salivary cytokine levels were presented as concentrations.
A statistical software package was used for all data analyses. If the clinical and biochemical data did not present normal distribution as checked by Shapiro Wilk's normality test, the analyses were performed by using nonparametric methods. The Kruskal-Wallis test with Dunn-Bonferroni post hoc method was applied to compare the study groups regarding clinical indices and oral biofluid levels of Activin-A and IL-1β. The presence and degree of linear association of cytokine levels in GCF and saliva with clinical indices were analyzed by Spearman rank correlation coefficient. p<0.05 was considered as a threshold for statistical significance.
- Conditions
- Periodontitis, Gingivitis, Periodontal Health
- Being tested
- Periodontal clinical measurements, GCF and saliva sampling
- Medical subject headings
- Periodontitis, Gingivitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Periodontal clinical measurements, GCF and saliva samplingOther
Clinical periodontal indices included probing depth (PD), clinical attachment loss (CAL), the dichotomous scoring of bleeding on probing (BOP +/-), gingival index (GI), and plaque index (PI). Clinical recordings were performed at six points (mesiobuccal, buccal, distobuccal, mesiopalatal, palatal, and distopalatal) of all teeth, except the 3rd molars.
GCF and saliva samples were obtained 1 day following the clinical measurements. Unstimulated whole saliva was collected from all participants. GCF was sampled with paper strips from two deepest pockets in periodontitis group; the most inflamed sites with clinical signs of redness or edema in gingivitis group; and the sites without visible inflammation in periodontally healthy group. GCF and saliva samples were stored at -80 °C until further analysis.
| Study group | Role | What they receive |
|---|---|---|
| Periodontitis | This group consisted of patients with generalized stage III periodontitis, who had interproximal CAL≥5 mm and PD≥6 mm as well as radiographical bone loss extending to the mid-third of the root or beyond at 30% of the teeth or more. CAL was not caused by trauma-related gingival recession, dental caries extending into the cervical areas of the teeth, endodontic lesions draining through the marginal periodontium, and the distal bone loss in adjacent second molars due to extractions of third molars. They showed no more than four teeth loss due to periodontitis. Receives: Other: Periodontal clinical measurements, GCF and saliva sampling | |
| Gingivitis | This group demonstrated no detectable interproximal CAL or radiographical bone loss. PD was ≤3 mm and BOP (%) was ≥30% in the entire mouth. Receives: Other: Periodontal clinical measurements, GCF and saliva sampling | |
| Periodontal health | This healthy control group had an intact periodontium without detectable CAL and radiographical bone loss. PD was ≤3 mm and BOP (%) was <10% in the entire mouth. Receives: Other: Periodontal clinical measurements, GCF and saliva sampling |
What is being measured
The primary outcome is the main question the study is designed to answer.
GCF Activin-A levels
total amount (ng)
Measured: 24 hours after 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 posted31 Oct 2023
- Study start22 Mar 2019
- Primary completion27 Jan 2020
- Study completion2 Feb 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PeriodontitisStudies 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
- 75 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Aydin Adnan Menderes University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Beral Afacan, Aydin Adnan Menderes University
- Investigators
- Beral Afacan, Principal investigator, Department of Periodontology, School of Dentistry, Aydın Adnan Menderes University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06110221
- Sponsor's protocol ID
- Activin-A
- Status last verified
- Oct 2023
- First submitted
- 26 Oct 2023
- Last updated
- 31 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Oral Biofluid Levels of Activin-A and Interleukin-1 Beta Levels in Periodontal Health and Disease
- ClinicalTrials.gov ID
- NCT06110221
- Acronym / sponsor ID
- Activin-A
- Conditions
- Periodontitis, Gingivitis, Periodontal Health
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- Aydin Adnan Menderes UniversityUniversity, hospital or other
- Study start
- 22 Mar 2019 (actual)
- Primary completion
- 27 Jan 2020 (actual)
- Study completion
- 2 Feb 2020 (actual)
- First posted
- 31 Oct 2023 (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.
Activin-A belongs to the transforming growth factor-beta superfamily and is a multifunctional cytokine that plays a role in inflammation, immune response, tissue repair and regeneration. Proinflammatory cytokine interleukin-1beta (IL-1β) can increase Activin-A expression in various cell types. This study aims to evaluate gingival crevicular fluid (GCF) and salivary Activin-A and IL-β levels in stage III periodontitis. Seventy-five systemically healthy and non-smoker volunteers consisting of 23 stage III periodontitis, 26 gingivitis and 26 periodontally healthy were enrolled. Full-mouth clinical periodontal indices were recorded, unstimulated whole saliva and GCF samples were obtained, Activin-A and IL-1β total amounts were determined by enzyme-linked immunosorbent assay. Statistical comparisons were performed using non-parametric tests.
Detailed description
Participants were divided into three groups according to the diagnostic criteria proposed by the Classification of Periodontal and Peri-implant Diseases and Conditions; I. Periodontitis group (n=23), II. Gingivitis group (n=26) III. Periodontally healthy group (n=26)
Clinical periodontal indices included probing depth (PD), clinical attachment loss (CAL), the dichotomous scoring of bleeding on probing (BOP +/-), gingival index (GI), and plaque index (PI). Clinical recordings were performed at six points (mesiobuccal, buccal, distobuccal, mesiopalatal/mesiolingual, palatal/lingual, and distopalatal/distolingual) of all teeth, except the 3rd molars, by a single investigator using a conventional periodontal probe.
Interproximal radiographic bone loss on the digital panoramic radiographs were evaluated, as the ratio of the distance between the bone crest and the cemento-enamel junction to the length of the root.
GCF and unstimulated whole saliva samples were obtained 1 day following the clinical periodontal measurements. Immediately after saliva collection, GCF was collected from the buccal aspects of non-contiguous interproximal sites in two single-rooted teeth via steril paper strips. Fluid samples were obtained from two deepest pockets in periodontitis group and the most inflamed sites with clinical signs of redness or edema in gingivitis group. In the periodontally healthy groups, samples were taken from the sites without visible inflammation. All samples were stored at -80 °C until further analysis.
Measurement of Activin-A and IL-1β levels in GCF and saliva samples were performed by the commercially available enzyme-linked immunosorbent assay (ELISA) kits. While GCF cytokine levels were expressed as both total amounts at two samples per 30 s and concentrations, salivary cytokine levels were presented as concentrations.
A statistical software package was used for all data analyses. If the clinical and biochemical data did not present normal distribution as checked by Shapiro Wilk's normality test, the analyses were performed by using nonparametric methods. The Kruskal-Wallis test with Dunn-Bonferroni post hoc method was applied to compare the study groups regarding clinical indices and oral biofluid levels of Activin-A and IL-1β. The presence and degree of linear association of cytokine levels in GCF and saliva with clinical indices were analyzed by Spearman rank correlation coefficient. p<0.05 was considered as a threshold for statistical significance.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Day
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Periodontitis | – | Other: Periodontal clinical measurements, GCF and saliva samplingThis group consisted of patients with generalized stage III periodontitis, who had interproximal CAL≥5 mm and PD≥6 mm as well as radiographical bone loss extending to the mid-third of the root or beyond at 30% of the teeth or more. CAL was not caused by trauma-related gingival recession, dental caries extending into the cervical areas of the teeth, endodontic lesions draining through the marginal periodontium, and the distal bone loss in adjacent second molars due to extractions of third molars. They showed no more than four teeth loss due to periodontitis. |
| Gingivitis | – | Other: Periodontal clinical measurements, GCF and saliva samplingThis group demonstrated no detectable interproximal CAL or radiographical bone loss. PD was ≤3 mm and BOP (%) was ≥30% in the entire mouth. |
| Periodontal health | – | Other: Periodontal clinical measurements, GCF and saliva samplingThis healthy control group had an intact periodontium without detectable CAL and radiographical bone loss. PD was ≤3 mm and BOP (%) was <10% in the entire mouth. |
Who may qualify
- Ages
- 27 to 48 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- This prospective case-control study consecutively enrolled 75 individuals (39 females and 36 males and; aged 27 to 48 years; mean age, 37.30 ± 5.10 years) from the Department of Periodontology, School of Dentistry, Aydın Adnan Menderes University, Aydın, Turkey, in the period from March 2019 to January 2020.
Key inclusion criteria (2 listed)
- the presence of no history of smoking (determined by self-reporting)
- at least 18 natural teeth excluding 3rd molars.
Key exclusion criteria (5 listed)
- the presence of systemic conditions (diabetes mellitus, rheumatoid arthritis, cardiovascular system diseases, endocrine, immunologic, and mucocutaneous disorders) - use of antibiotics, antihypertensives immunosuppressive and anti-inflammatory drugs within the past 6 months and topical antiseptic solutions in the last 3 months
- having periodontal treatment in the previous year
- wearing removable partial dentures or orthodontic appliances
- restorative and endodontic therapy requirements
- pregnant or nursing women.
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 |
|---|---|---|
| Periodontal clinical measurements, GCF and saliva samplingClinical periodontal indices included probing depth (PD), clinical attachment loss (CAL), the dichotomous scoring of bleeding on probing (BOP +/-), gingival index (GI), and plaque index (PI). Clinical recordings were performed at six points (mesiobuccal, buccal, distobuccal, mesiopalatal, palatal, and distopalatal) of all teeth, except the 3rd molars. GCF and saliva samples were obtained 1 day following the clinical measurements. Unstimulated whole saliva was collected from all participants. GCF was sampled with paper strips from two deepest pockets in periodontitis group; the most inflamed sites with clinical signs of redness or edema in gingivitis group; and the sites without visible inflammation in periodontally healthy group. GCF and saliva samples were stored at -80 °C until further analysis. | Other | Gingivitis, Periodontal health, Periodontitis |
Primary outcome
GCF Activin-A levels
Time frame: 24 hours after clinical periodontal measurements
total amount (ng)
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 31 Oct 2023.
Related trials for Periodontitis
Recruiting
Effect of Cryotherapeutic and Nanotherapeutic Sodium Hypochlorite on Post-Operative Endodontic Pain.
Symptomatic Irreversible Pulpitis, Symptomatic Apical Periodontitis
Active, not recruitingObservational study
A Retrospective Comparative Evaluation of Omega-3 and Resveratrol Supplementation in Patients With Periodontitis
Periodontitis
Recruiting
Probiotics Versus Antibiotics as an Adjuvant to Non-surgical Periodontal Treatment Among Smokers With Stage II, Grade B Periodontitis
Probiotics, Antibiotics
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.
Beral Afacan principal investigator
Department of Periodontology, School of Dentistry, Aydın Adnan Menderes 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 Periodontitis and Gingivitis, 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 2 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 31 Oct 2023. 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?
GCF Activin-A levels (time frame: 24 hours after 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 31 Oct 2023.