PeriodontitisNCT05449093
GCF Galectin-3 and Interleukin-1beta Levels in Periodontitis.
An observational study of Periodontitis and Periodontal Inflammation, run by Aydin Adnan Menderes University at 1 site in Turkey (Türkiye).
Trial summary
This study aims to evaluate gingival crevicular fluid Galectin-3 and Interleukin-1beta levels in different grades (B and C) of stage 3 periodontitis, concurrently, and also to investigate their discriminative efficiencies in periodontal diseases. Read more about this study
- Who is it for?
- Ages 25 to 52 yearsHealthy volunteers can take part
- Conditions the study is for
- Periodontitis, Periodontal Inflammation
- What is being tested?
- Periodontal clinical measurements and gingival crevicular fluid sampling
- How many people
- 80 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 21 Feb 2019to 2 Sep 2019
- 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 52 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: A total of 80 systemically healthy and non-smoker individuals (36 males and 44 females) aged 25-52 years were consecutively included.
Who may be able to join
- Non-smokers with no history of smoking (determined by self-reporting)
- Individuals who had at least 20 teeth (excluding third molars)
Who cannot join
- Patients with diagnosed medical illness such as diabetes mellitus, rheumatoid arthritis, cardiovascular diseases, immunological diseases.
- Patients who under any medication including immunosuppressants, steroids, non-steroidal anti-inflammatory drugs, antibiotics, antiepileptic drugs, calcium channel blockers, beta-blockers, anticoagulants, hormonal contraceptives and nutritional supplements within the past 6 months, topical antiseptic solutions in the last 3 months.
- Pregnant and lactating women
- Individuals who had orthodontic appliances or removable partial dentures
- Individuals who had undergone professional teeth cleaning within the past year
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Adnan Menderes University, Faculty of Dentistry, Department of Periodontology
Aydin, 09100
About this study
Official title: Gingival Crevicular Fluid Galectin-3 and Interleukin-1beta Levels in Stage 3 Periodontitis With Grade B and C.
This study aims to evaluate gingival crevicular fluid Galectin-3 and Interleukin-1beta levels in different grades (B and C) of stage 3 periodontitis, concurrently, and also to investigate their discriminative efficiencies in periodontal diseases. A total of 80 systemically healthy and non-smoker individuals, 20 stage 3 grade C periodontitis 20 stage 3 grade B periodontitis, 20 gingivitis and 20 periodontally healthy were enrolled. Clinical periodontal parameters were recorded and GCF Galectin-3 and interleukin-1 beta total amounts were measured by ELISA. Receiver operating characteristics curve was used for estimating the area under the curve.
Read the detailed description
A total of 80 systemically healthy and non-smoker individuals, 20 stage 3 grade C periodontitis 20 stage 3 grade B periodontitis, 20 gingivitis and 20 periodontally healthy were enrolled.
Periodontal clinical measurements including the probing depth, clinical attachment loss, the dichotomous recording (present/absent) of bleeding on probing, gingival index, and the plaque index at six sites (distobuccal, buccal, mesiobuccal, distopalatinal/lingual, palatinal/lingual, mesiopalatinal/lingual) on all teeth, except third molars, were performed by a graded periodontal probe.
According to the diagnostic criteria proposed by the 2017 International Workshop on the Classification of Periodontal and Peri-implant Diseases and Conditions18 participants were classified into four distinct groups based on their periodontal conditions: 1) 20 patients with generalized stage 3 grade C periodontitis; 2) 20 patients with generalized stage 3 grade B periodontitis; 3) 20 patients with gingivitis; and 4) 20 periodontally healthy individuals.
Gingival crevicular fluid was sampled from the buccal aspects of two non-adjacent interproximal sites in single-rooted teeth. Standardized absorbent paper strips were used for sampling. In periodontitis groups, samples were taken from two deepest pockets of single-rooted teeth. Samples were obtained from the sites with visible signs of inflammation in patients with gingivitis and without bleeding on probing in the healthy controls. The absorbed fluid volume was measured by a precalibrated electronic device.
Galectin-3 and interleukin-1 beta levels in gingival crevicular fluids samples were measured by the ELISA via commercial kits in line with the manufacturer's guidelines. Protein concentrations were calculated from the standard curve. Gingival crevicular fluid results for two analytes were expressed as total amounts at two samples per sampling time.
Normality of the data was checked by Shapiro Wilk's normality test. Comparisons of clinical parameters and gingival crevicular fluids biomaker levels among the study groups were performed using Kruskal-Wallis test and Dunn's test (with Bonferroni correction) was used to pairwise comparisons for non-normally distributed variables. Receiver operating characteristic (ROC) curves were constructed to assess the ability of two analytes for diagnosis of periodontitis. Statistical significance was considered at p< 0.05 for all the tests.
- Conditions
- Periodontitis, Periodontal Inflammation
- Being tested
- Periodontal clinical measurements and gingival crevicular fluid sampling
- Medical subject headings
- Periodontitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Periodontal clinical measurements and gingival crevicular fluid samplingOther
Periodontal clinical meaurements including the probing depth, clinical attachment loss, the dichotomous recording (present/absent) of bleeding on probing, gingival index, and the plaque index at six sites (distobuccal, buccal, mesiobuccal, distopalatinal/lingual, palatinal/lingual, mesiopalatinal/lingual) on all teeth, except third molars, were performed using manuel periodontal probe.
Standardized absorbent paper strips were used for gingival crevicular fluid sampling. A sterile paper strip was gently inserted into the gingival sulcus/periodontal pocket until mild resistance was felt and were kept in place for 30 seconds. The absorbed fluid volume was measured by a precalibrated electronic device.
| Study group | Role | What they receive |
|---|---|---|
| Stage 3 Grade C Periodontitis | Generalized stage 3 periodontitis patients had interproximal clinical attachment loss ≥ 5 mm at 30 % of the teeth or more. Care was taken to ensure that clinical attachment loss was caused by periodontal causes. These patients had also radiographic bone loss extending to the mid-third of the root or beyond and probing depth ≥ 6 mm at 30 % of the teeth or more as well as Class II-III furcation involvement. The grade of periodontitis was estimated with indirect evidence of progression through % of bone loss/age. Radiographic bone loss of each natural tooth was assessed by using the panoramic radiograph. The tooth showing the most extensive bone loss was determined and % of bone loss/age were calculated. If this value was higher than 1.0, the patients were assigned to grade C. Receives: Other: Periodontal clinical measurements and gingival crevicular fluid sampling | |
| Stage 3 Grade B Periodontitis | Generalized stage 3 periodontitis patients had interproximal clinical attachment loss ≥ 5 mm at 30 % of the teeth or more. Care was taken to ensure that CAL was caused by periodontal causes.These patients had also radiographic bone loss extending to the mid-third of the root or beyond and probing depth ≥ 6 mm at 30 % of the teeth or more as well as Class II-III furcation involvement. The grade of periodontitis was estimated with indirect evidence of progression through % of bone loss/age. Radiographic bone loss of each natural tooth was assessed by using the panoramic radiograph. The tooth showing the most extensive bone loss was determined and % of bone loss/age were calculated. When this value was between 0.25 and 1.0, patients were included in grade B. Receives: Other: Periodontal clinical measurements and gingival crevicular fluid sampling | |
| Gingivitis | Gingivitis patients showed probing depth ≤ 3 mm with bleeding on probing ≥ 30 % in the entire mouth as well as no interproximal clinical attachment loss or radiographic bone loss. Receives: Other: Periodontal clinical measurements and gingival crevicular fluid sampling | |
| Periodontal Health | Periodontally healthy individuals in the control group had an intact periodontium or a reduced periodontium (without detectable interproximal clinical attachment loss or radiographic bone loss) in a non-periodontitis patient. In this group, probing depth was ≤ 3 mm and bleeding on probing was < 10 % in the whole mouth. Receives: Other: Periodontal clinical measurements and gingival crevicular fluid sampling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gingival crevicular fluid Galectin-3 levels
ng
Measured: 24 hours after clinical periodontal measurements
Gingival crevicular fluid interleukin-1 beta levels
pg
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 posted8 Jul 2022
- Study start21 Feb 2019
- Primary completion23 Aug 2019
- Study completion2 Sep 2019
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
- 80 participants (actual)
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, Aydin Adnan Menderes UniversityGülnur Emingil, Study director, İzmir Ege UniversityHarika Atmaca İlhan, Principal investigator, Manisa Celal Bayar UniversityTimur Köse, Principal investigator, İzmir Ege University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05449093
- Sponsor's protocol ID
- bafacan0922
- Status last verified
- Jul 2022
- First submitted
- 4 Jul 2022
- Last updated
- 8 Jul 2022
- 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 8 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Gingival Crevicular Fluid Galectin-3 and Interleukin-1beta Levels in Stage 3 Periodontitis With Grade B and C.
- ClinicalTrials.gov ID
- NCT05449093
- Acronym / sponsor ID
- bafacan0922
- Conditions
- Periodontitis, Periodontal Inflammation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Aydin Adnan Menderes UniversityUniversity, hospital or other
- Study start
- 21 Feb 2019 (actual)
- Primary completion
- 23 Aug 2019 (actual)
- Study completion
- 2 Sep 2019 (actual)
- First posted
- 8 Jul 2022 (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.
This study aims to evaluate gingival crevicular fluid Galectin-3 and Interleukin-1beta levels in different grades (B and C) of stage 3 periodontitis, concurrently, and also to investigate their discriminative efficiencies in periodontal diseases. A total of 80 systemically healthy and non-smoker individuals, 20 stage 3 grade C periodontitis 20 stage 3 grade B periodontitis, 20 gingivitis and 20 periodontally healthy were enrolled. Clinical periodontal parameters were recorded and GCF Galectin-3 and interleukin-1 beta total amounts were measured by ELISA. Receiver operating characteristics curve was used for estimating the area under the curve.
Detailed description
A total of 80 systemically healthy and non-smoker individuals, 20 stage 3 grade C periodontitis 20 stage 3 grade B periodontitis, 20 gingivitis and 20 periodontally healthy were enrolled.
Periodontal clinical measurements including the probing depth, clinical attachment loss, the dichotomous recording (present/absent) of bleeding on probing, gingival index, and the plaque index at six sites (distobuccal, buccal, mesiobuccal, distopalatinal/lingual, palatinal/lingual, mesiopalatinal/lingual) on all teeth, except third molars, were performed by a graded periodontal probe.
According to the diagnostic criteria proposed by the 2017 International Workshop on the Classification of Periodontal and Peri-implant Diseases and Conditions18 participants were classified into four distinct groups based on their periodontal conditions: 1) 20 patients with generalized stage 3 grade C periodontitis; 2) 20 patients with generalized stage 3 grade B periodontitis; 3) 20 patients with gingivitis; and 4) 20 periodontally healthy individuals.
Gingival crevicular fluid was sampled from the buccal aspects of two non-adjacent interproximal sites in single-rooted teeth. Standardized absorbent paper strips were used for sampling. In periodontitis groups, samples were taken from two deepest pockets of single-rooted teeth. Samples were obtained from the sites with visible signs of inflammation in patients with gingivitis and without bleeding on probing in the healthy controls. The absorbed fluid volume was measured by a precalibrated electronic device.
Galectin-3 and interleukin-1 beta levels in gingival crevicular fluids samples were measured by the ELISA via commercial kits in line with the manufacturer's guidelines. Protein concentrations were calculated from the standard curve. Gingival crevicular fluid results for two analytes were expressed as total amounts at two samples per sampling time.
Normality of the data was checked by Shapiro Wilk's normality test. Comparisons of clinical parameters and gingival crevicular fluids biomaker levels among the study groups were performed using Kruskal-Wallis test and Dunn's test (with Bonferroni correction) was used to pairwise comparisons for non-normally distributed variables. Receiver operating characteristic (ROC) curves were constructed to assess the ability of two analytes for diagnosis of periodontitis. Statistical significance was considered at p< 0.05 for all the tests.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Stage 3 Grade C Periodontitis | – | Other: Periodontal clinical measurements and gingival crevicular fluid samplingGeneralized stage 3 periodontitis patients had interproximal clinical attachment loss ≥ 5 mm at 30 % of the teeth or more. Care was taken to ensure that clinical attachment loss was caused by periodontal causes. These patients had also radiographic bone loss extending to the mid-third of the root or beyond and probing depth ≥ 6 mm at 30 % of the teeth or more as well as Class II-III furcation involvement. The grade of periodontitis was estimated with indirect evidence of progression through % of bone loss/age. Radiographic bone loss of each natural tooth was assessed by using the panoramic radiograph. The tooth showing the most extensive bone loss was determined and % of bone loss/age were calculated. If this value was higher than 1.0, the patients were assigned to grade C. |
| Stage 3 Grade B Periodontitis | – | Other: Periodontal clinical measurements and gingival crevicular fluid samplingGeneralized stage 3 periodontitis patients had interproximal clinical attachment loss ≥ 5 mm at 30 % of the teeth or more. Care was taken to ensure that CAL was caused by periodontal causes.These patients had also radiographic bone loss extending to the mid-third of the root or beyond and probing depth ≥ 6 mm at 30 % of the teeth or more as well as Class II-III furcation involvement. The grade of periodontitis was estimated with indirect evidence of progression through % of bone loss/age. Radiographic bone loss of each natural tooth was assessed by using the panoramic radiograph. The tooth showing the most extensive bone loss was determined and % of bone loss/age were calculated. When this value was between 0.25 and 1.0, patients were included in grade B. |
| Gingivitis | – | Other: Periodontal clinical measurements and gingival crevicular fluid samplingGingivitis patients showed probing depth ≤ 3 mm with bleeding on probing ≥ 30 % in the entire mouth as well as no interproximal clinical attachment loss or radiographic bone loss. |
| Periodontal Health | – | Other: Periodontal clinical measurements and gingival crevicular fluid samplingPeriodontally healthy individuals in the control group had an intact periodontium or a reduced periodontium (without detectable interproximal clinical attachment loss or radiographic bone loss) in a non-periodontitis patient. In this group, probing depth was ≤ 3 mm and bleeding on probing was < 10 % in the whole mouth. |
Who may qualify
- Ages
- 25 to 52 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- A total of 80 systemically healthy and non-smoker individuals (36 males and 44 females) aged 25-52 years were consecutively included.
Key inclusion criteria (2 listed)
- Non-smokers with no history of smoking (determined by self-reporting)
- Individuals who had at least 20 teeth (excluding third molars)
Key exclusion criteria (5 listed)
- Patients with diagnosed medical illness such as diabetes mellitus, rheumatoid arthritis, cardiovascular diseases, immunological diseases.
- Patients who under any medication including immunosuppressants, steroids, non-steroidal anti-inflammatory drugs, antibiotics, antiepileptic drugs, calcium channel blockers, beta-blockers, anticoagulants, hormonal contraceptives and nutritional supplements within the past 6 months, topical antiseptic solutions in the last 3 months.
- Pregnant and lactating women
- Individuals who had orthodontic appliances or removable partial dentures
- Individuals who had undergone professional teeth cleaning within the past year
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 and gingival crevicular fluid samplingPeriodontal clinical meaurements including the probing depth, clinical attachment loss, the dichotomous recording (present/absent) of bleeding on probing, gingival index, and the plaque index at six sites (distobuccal, buccal, mesiobuccal, distopalatinal/lingual, palatinal/lingual, mesiopalatinal/lingual) on all teeth, except third molars, were performed using manuel periodontal probe. Standardized absorbent paper strips were used for gingival crevicular fluid sampling. A sterile paper strip was gently inserted into the gingival sulcus/periodontal pocket until mild resistance was felt and were kept in place for 30 seconds. The absorbed fluid volume was measured by a precalibrated electronic device. | Other | Gingivitis, Periodontal Health, Stage 3 Grade B Periodontitis, Stage 3 Grade C Periodontitis |
Primary outcome
Gingival crevicular fluid Galectin-3 levels
Time frame: 24 hours after clinical periodontal measurements
ng
Gingival crevicular fluid interleukin-1 beta levels
Time frame: 24 hours after clinical periodontal measurements
pg
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 8 Jul 2022.
- Individual participant dataSharing planned: No
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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.
Beral Afacan principal investigator
Aydin Adnan Menderes University
Gülnur Emingil study director
İzmir Ege University
Harika Atmaca İlhan principal investigator
Manisa Celal Bayar 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 Periodontal Inflammation, 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 8 Jul 2022. 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 Galectin-3 levels (time frame: 24 hours after clinical periodontal measurements). The study lists 2 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 8 Jul 2022.