Periodontal HealthNCT05395455
Gingival Crevicular Fluid, Salivary, and Serum Biomarkers Levels in Periodontal Treatment
A study testing Non-surgical periodontal treatment in people with Periodontal Health and Periodontitis, run by Marmara University at 1 site in Turkey (Türkiye).
Trial summary
The present study aimed to assess the effect of non-surgical periodontal treatment on gingival crevicular fluid (GCF), saliva, and serum IL-26, IL-6, and IL-10 levels in stage III grade B periodontitis (SIII-GB-P) and C periodontitis (SIII-GC-P) patients. Read more about this study
- Who is it for?
- Ages 30 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Periodontal Health, Periodontitis
- What is being tested?
- Non-surgical periodontal treatment
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 12 Nov 2018to 23 Jan 2020
- Phase
- Interventional
- 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 30 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- systemically healthy and non-smoker individuals
- having ≥20 teeth present (except third molars)
- individuals with periodontally healthy, stage III grade B and C periodontitis diagnoses
Who cannot join
- having any diagnosed medical disorders
- usage of antibiotics, non-steroidal anti-inflammatory drugs, and immunosuppressive agents within the past 6 months
- having any non-inflammatory destructive periodontal disease
- non-surgical/surgical periodontal therapy received in the past year
- pregnant/ lactating/ postmenopausal females
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Non-surgical Periodontal Treatment on Gingival Crevicular Fluid, Salivary and Serum Interleukin-26 Levels in Stage III Grade B and C Periodontitis
The present study aimed to assess the effect of non-surgical periodontal treatment on gingival crevicular fluid (GCF), saliva, and serum IL-26, IL-6, and IL-10 levels in stage III grade B periodontitis (SIII-GB-P) and C periodontitis (SIII-GC-P) patients. 25 periodontally healthy, 25 SIII-GB-P, and 25 SIII-GC-P participants were enrolled. At baseline, GCF, saliva, and serum samples were collected and the whole mouth clinical periodontal parameters were recorded. Periodontitis patients received non-surgical periodontal treatment (NSPT). Clinical parameters and samples were re-collected at 1 and 3 months after NSPT. GCF, saliva, and serum IL-26, IL-6, and IL-10 were analyzed by ELISA. Data were analyzed using appropriate statistical tests.
Read the detailed description
Periodontitis is an inflammatory process that can result in tooth loss by destroying teeth-supporting tissues. Interleukin (IL) 26, is one of the recent members of the IL-10 cytokine family. The elevated level of IL-26 expression is associated with inflammatory disorders.
IL-6, a pro-inflammatory cytokine and is one of the important molecules in the regulation of inflammatory immune responses in periodontitis. IL-10, an anti-inflammatory cytokine, affects monocytes and macrophages and their immune mediator release.
This study is the first controlled clinical study that examines the levels of IL-26 in GCF, saliva, and serum in two different periodontitis, and evaluates the situation before and after the treatment. The first hypothesis of this study GCF, salivary, and serum IL-26 and IL-6 levels will be high and GCF, salivary and serum IL-10 will be low in periodontitis groups, in contrast to the periodontal health the second hypothesis of this study is that after periodontal treatment, GCF, saliva, and serum IL-26 and IL-6 will decrease and GCF, saliva, and serum IL-10 will increase.
Based on these hypotheses, the aim of the study is; to compare the levels of IL-26, IL-6, and IL-10 in GCF, saliva, and serum of healthy controls, SIII-GB-P, and SIII-GC-P subjects and to evaluate the effect of periodontal treatment.
A total of 75 systemically healthy patients; 25 periodontally healthy, 25 SIII-GB-P, and 25 SIII-GC-P were included in this study. The clinical periodontal examination, including measurement of probing depth (PD), clinical attachment level (CAL), bleeding on probing (BOP), gingival index (GI), and plaque index (PI) was performed at 6 sites per tooth, except the third molars. The presence of alveolar bone loss was assessed on the digital panoramic radiograph in each participant, which was supplemented with periapical radiographs if necessary.
The periodontal status of each patient was evaluated by a single calibrated periodontist with a manual probe. The diagnosis of periodontitis or periodontally health was determined according to the 2017 World Workshop on Classification of Periodontal and Peri-Implant Diseases and Conditions. Periodontally healthy individuals (n=25) in the control group had no sites with PD >3 mm and CAL >2 mm and also no radiographic evidence of alveolar bone loss. BOP was <10% in the whole mouth and exhibited no history of periodontitis. The periodontitis stage III patients had a minimum of 3 teeth apart from the first molars and incisors showing CAL ≥5 mm and PD ≥6 mm and showed no>4 teeth loss caused by periodontitis. The radiographic bone loss extends from coronal to middle third or beyond. Radiographic bone loss was determined from the tooth showing the most severe bone loss as a percentage of root length. If the values of bone loss %/age were between 0.25 and 1.0, the patients were assigned to grade B (n=25). If higher than 1.0, the patients were assigned to grade C (n=25).
Treatment The periodontitis patients received conventional scaling and root planning (SRP) under local anesthesia in a total of 4 sessions in two weeks. SRP was performed by the same periodontist using ultrasonic inserts and manual periodontal curettes. Re-evaluations were performed at 1 and 3 months following the completion of the treatment.
GCF, Saliva and Serum Sampling Filter paper strips were used to collect GCF samples. In the healthy control group, GCF was collected from the interproximal sites of single-rooted and multiple rooted teeth from each quadrant. GCF was collected from the sites with PD ≥ 6 mm and radiographic bone loss in periodontitis groups. Selected sites were isolated with cotton rolls. The paper strip was removed after 30 sec after inserting the periodontal pocket. A total of 5 mL of unstimulated whole saliva was collected by the passive drool method in the morning. The saliva was collected over a period of 5 minutes with instructions to pool saliva on the floor of the mouth and passively drool it into a sterile glass beaker and samples are immediately transferred to a 2 mL polypropylene tube. A total of 5 mL of blood was collected from the antecubital fossa by venepuncture method. Serum was isolated from the blood by centrifuging at 5000 rpm for 10 minutes followed by its rapid transfer to a sterile polypropylene tube. All the samples were stored at -80°C.
Biomarker Immunoassays GCF, saliva, and serum samples were thawed on ice. The saliva samples were centrifuged at 5.000 rpm for 15 minutes at room temperature, and supernatants were immediately used for assays. GCF, serum, and salivary samples of IL-26, IL-10, and IL-6 were measured by ELISA using commercial kits.
Statistical Analysis All statistical analyses were carried out with the standard statistical software package. For the intra-group comparisons, if the data were not normally disturbed, the Friedman test and the Dunn test with the Bonferroni correction were used to analyze the change between baseline and 1 month and 3 months after treatment. For inter-group comparisons, the Mann-Whitney U test was performed. The Spearman's rank correlation test was used to detect the correlations of biochemical parameters with clinical parameters and each other in periodontitis group before and after treatment. All tests were performed at a significance level of p<0.05.
- Conditions
- Periodontal Health, Periodontitis
- Being tested
- Non-surgical periodontal treatment
- Keywords
- periodontitis, periodontal treatment
- Medical subject headings
- Periodontitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non-surgical periodontal treatmentProcedure or surgery
Treatment of patients with periodontitis was performed scaling and root planing by using manual and ultrasonic instruments.
| Study group | Role | What they receive |
|---|---|---|
| Periodontally Healthy | No intervention | Systemically and periodontally healthy |
| Stage III Grade B Periodontitis | Active comparator | The patients were subjected to quadrant-wise full-mouth subgingival scaling and root planing under local anesthesia. The entire non-surgical periodontal treatment of periodontitis groups was completed in a total of 4 sessions in two weeks. Receives: Procedure: Non-surgical periodontal treatment |
| Stage III Grade C Periodontitis | Active comparator | The patients were subjected to quadrant-wise full-mouth subgingival scaling and root planing under local anesthesia. The entire non-surgical periodontal treatment of periodontitis groups was completed in a total of 4 sessions in two weeks. Receives: Procedure: Non-surgical periodontal treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
GCF IL-26 level (ng/ml)
Change in GCF IL-26 levels from baseline to 1 month and 3 months after treatment
Measured: Baseline to 1 month and 3 months after treatment
GCF IL-6 level (ng/ml)
Change in GCF IL-6 levels from baseline to 1 month and 3 months after treatment
Measured: Baseline to 1 month and 3 months after treatment
GCF IL-10 level (ng/ml)
Change in GCF IL-10 levels from baseline to 1 month and 3 months after treatment
Measured: Baseline to 1 month and 3 months after treatment
Secondary outcomes (6)
Saliva IL-26 level (ng/ml)
Change in saliva IL-26 levels from baseline to 1 month and 3 months after treatment
Measured: Baseline to 1 month and 3 months after treatment
Saliva IL-6 level (ng/ml)
Change in saliva IL-6 levels from baseline to 1 month and 3 months after treatment
Measured: Baseline to 1 month and 3 months after treatment
Saliva IL-10 level (ng/ml)
Change in saliva IL-6 levels from baseline to 1 month and 3 months after treatment
Measured: Baseline to 1 month and 3 months after treatment
Serum IL-26 level (ng/ml)
Change in serum IL-26 levels from baseline to 1 month and 3 months after treatment
Measured: Baseline to 1 month and 3 months after treatment
Serum IL-6 level (ng/ml)
Change in serum IL-6 levels from baseline to 1 month and 3 months after treatment
Measured: Baseline to 1 month and 3 months after treatment
Serum IL-10 level (ng/ml)
Change in serum IL-10 levels from baseline to 1 month and 3 months after treatment
Measured: Baseline to 1 month and 3 months after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 May 2022
- Study start12 Nov 2018
- Primary completion23 Jan 2020
- Study completion23 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Periodontal HealthStudies of the same condition, open and under way.
- More trials run by Marmara 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- Marmara University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05395455
- Sponsor's protocol ID
- SAG-C-DRP-241018-0575
- Status last verified
- May 2022
- First submitted
- 24 May 2022
- Last updated
- 27 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 27 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Non-surgical Periodontal Treatment on Gingival Crevicular Fluid, Salivary and Serum Interleukin-26 Levels in Stage III Grade B and C Periodontitis
- ClinicalTrials.gov ID
- NCT05395455
- Acronym / sponsor ID
- SAG-C-DRP-241018-0575
- Conditions
- Periodontal Health, Periodontitis
- Keywords
- periodontitis, periodontal treatment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- Marmara UniversityUniversity, hospital or other
- Study start
- 12 Nov 2018 (actual)
- Primary completion
- 23 Jan 2020 (actual)
- Study completion
- 23 Jan 2020 (actual)
- First posted
- 27 May 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.
The present study aimed to assess the effect of non-surgical periodontal treatment on gingival crevicular fluid (GCF), saliva, and serum IL-26, IL-6, and IL-10 levels in stage III grade B periodontitis (SIII-GB-P) and C periodontitis (SIII-GC-P) patients. 25 periodontally healthy, 25 SIII-GB-P, and 25 SIII-GC-P participants were enrolled. At baseline, GCF, saliva, and serum samples were collected and the whole mouth clinical periodontal parameters were recorded. Periodontitis patients received non-surgical periodontal treatment (NSPT). Clinical parameters and samples were re-collected at 1 and 3 months after NSPT. GCF, saliva, and serum IL-26, IL-6, and IL-10 were analyzed by ELISA. Data were analyzed using appropriate statistical tests.
Detailed description
Periodontitis is an inflammatory process that can result in tooth loss by destroying teeth-supporting tissues. Interleukin (IL) 26, is one of the recent members of the IL-10 cytokine family. The elevated level of IL-26 expression is associated with inflammatory disorders.
IL-6, a pro-inflammatory cytokine and is one of the important molecules in the regulation of inflammatory immune responses in periodontitis. IL-10, an anti-inflammatory cytokine, affects monocytes and macrophages and their immune mediator release.
This study is the first controlled clinical study that examines the levels of IL-26 in GCF, saliva, and serum in two different periodontitis, and evaluates the situation before and after the treatment. The first hypothesis of this study GCF, salivary, and serum IL-26 and IL-6 levels will be high and GCF, salivary and serum IL-10 will be low in periodontitis groups, in contrast to the periodontal health the second hypothesis of this study is that after periodontal treatment, GCF, saliva, and serum IL-26 and IL-6 will decrease and GCF, saliva, and serum IL-10 will increase.
Based on these hypotheses, the aim of the study is; to compare the levels of IL-26, IL-6, and IL-10 in GCF, saliva, and serum of healthy controls, SIII-GB-P, and SIII-GC-P subjects and to evaluate the effect of periodontal treatment.
A total of 75 systemically healthy patients; 25 periodontally healthy, 25 SIII-GB-P, and 25 SIII-GC-P were included in this study. The clinical periodontal examination, including measurement of probing depth (PD), clinical attachment level (CAL), bleeding on probing (BOP), gingival index (GI), and plaque index (PI) was performed at 6 sites per tooth, except the third molars. The presence of alveolar bone loss was assessed on the digital panoramic radiograph in each participant, which was supplemented with periapical radiographs if necessary.
The periodontal status of each patient was evaluated by a single calibrated periodontist with a manual probe. The diagnosis of periodontitis or periodontally health was determined according to the 2017 World Workshop on Classification of Periodontal and Peri-Implant Diseases and Conditions. Periodontally healthy individuals (n=25) in the control group had no sites with PD >3 mm and CAL >2 mm and also no radiographic evidence of alveolar bone loss. BOP was <10% in the whole mouth and exhibited no history of periodontitis. The periodontitis stage III patients had a minimum of 3 teeth apart from the first molars and incisors showing CAL ≥5 mm and PD ≥6 mm and showed no>4 teeth loss caused by periodontitis. The radiographic bone loss extends from coronal to middle third or beyond. Radiographic bone loss was determined from the tooth showing the most severe bone loss as a percentage of root length. If the values of bone loss %/age were between 0.25 and 1.0, the patients were assigned to grade B (n=25). If higher than 1.0, the patients were assigned to grade C (n=25).
Treatment The periodontitis patients received conventional scaling and root planning (SRP) under local anesthesia in a total of 4 sessions in two weeks. SRP was performed by the same periodontist using ultrasonic inserts and manual periodontal curettes. Re-evaluations were performed at 1 and 3 months following the completion of the treatment.
GCF, Saliva and Serum Sampling Filter paper strips were used to collect GCF samples. In the healthy control group, GCF was collected from the interproximal sites of single-rooted and multiple rooted teeth from each quadrant. GCF was collected from the sites with PD ≥ 6 mm and radiographic bone loss in periodontitis groups. Selected sites were isolated with cotton rolls. The paper strip was removed after 30 sec after inserting the periodontal pocket. A total of 5 mL of unstimulated whole saliva was collected by the passive drool method in the morning. The saliva was collected over a period of 5 minutes with instructions to pool saliva on the floor of the mouth and passively drool it into a sterile glass beaker and samples are immediately transferred to a 2 mL polypropylene tube. A total of 5 mL of blood was collected from the antecubital fossa by venepuncture method. Serum was isolated from the blood by centrifuging at 5000 rpm for 10 minutes followed by its rapid transfer to a sterile polypropylene tube. All the samples were stored at -80°C.
Biomarker Immunoassays GCF, saliva, and serum samples were thawed on ice. The saliva samples were centrifuged at 5.000 rpm for 15 minutes at room temperature, and supernatants were immediately used for assays. GCF, serum, and salivary samples of IL-26, IL-10, and IL-6 were measured by ELISA using commercial kits.
Statistical Analysis All statistical analyses were carried out with the standard statistical software package. For the intra-group comparisons, if the data were not normally disturbed, the Friedman test and the Dunn test with the Bonferroni correction were used to analyze the change between baseline and 1 month and 3 months after treatment. For inter-group comparisons, the Mann-Whitney U test was performed. The Spearman's rank correlation test was used to detect the correlations of biochemical parameters with clinical parameters and each other in periodontitis group before and after treatment. All tests were performed at a significance level of p<0.05.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Periodontally Healthy | No intervention | –Systemically and periodontally healthy |
| Stage III Grade B Periodontitis | Active comparator | Procedure: Non-surgical periodontal treatmentThe patients were subjected to quadrant-wise full-mouth subgingival scaling and root planing under local anesthesia. The entire non-surgical periodontal treatment of periodontitis groups was completed in a total of 4 sessions in two weeks. |
| Stage III Grade C Periodontitis | Active comparator | Procedure: Non-surgical periodontal treatmentThe patients were subjected to quadrant-wise full-mouth subgingival scaling and root planing under local anesthesia. The entire non-surgical periodontal treatment of periodontitis groups was completed in a total of 4 sessions in two weeks. |
Who may qualify
- Ages
- 30 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- systemically healthy and non-smoker individuals
- having ≥20 teeth present (except third molars)
- individuals with periodontally healthy, stage III grade B and C periodontitis diagnoses
Key exclusion criteria (5 listed)
- having any diagnosed medical disorders
- usage of antibiotics, non-steroidal anti-inflammatory drugs, and immunosuppressive agents within the past 6 months
- having any non-inflammatory destructive periodontal disease
- non-surgical/surgical periodontal therapy received in the past year
- pregnant/ lactating/ postmenopausal females
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 treatmentTreatment of patients with periodontitis was performed scaling and root planing by using manual and ultrasonic instruments. | Procedure or surgery | Stage III Grade B Periodontitis, Stage III Grade C Periodontitis |
Primary outcome
GCF IL-26 level (ng/ml)
Time frame: Baseline to 1 month and 3 months after treatment
Change in GCF IL-26 levels from baseline to 1 month and 3 months after treatment
GCF IL-6 level (ng/ml)
Time frame: Baseline to 1 month and 3 months after treatment
Change in GCF IL-6 levels from baseline to 1 month and 3 months after treatment
GCF IL-10 level (ng/ml)
Time frame: Baseline to 1 month and 3 months after treatment
Change in GCF IL-10 levels from baseline to 1 month and 3 months after treatment
6 secondary outcomes
Saliva IL-26 level (ng/ml)
Time frame: Baseline to 1 month and 3 months after treatment
Saliva IL-6 level (ng/ml)
Time frame: Baseline to 1 month and 3 months after treatment
Saliva IL-10 level (ng/ml)
Time frame: Baseline to 1 month and 3 months after treatment
Serum IL-26 level (ng/ml)
Time frame: Baseline to 1 month and 3 months after treatment
Serum IL-6 level (ng/ml)
Time frame: Baseline to 1 month and 3 months after treatment
Serum IL-10 level (ng/ml)
Time frame: Baseline to 1 month and 3 months after treatment
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 27 May 2022.
- Individual participant dataSharing planned: Undecided
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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?
A study testing Non-surgical periodontal treatment in people with Periodontal Health and Periodontitis, run by Marmara 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 3 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 27 May 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?
GCF IL-26 level (ng/ml) (time frame: Baseline to 1 month and 3 months after treatment). 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 27 May 2022.