Periodontal HealthNCT05005923
Effect of Periodontal Therapy on Biomarkers in Periodontitis
A study testing Non-surgically performed scaling and root planing 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 serum and salivary MMP-8, MAF, MIP-1α, M-CSF, and IL34 levels in periodontitis stage III grade B (P-III-B) and C (P-III-C) patients. 20 periodontally healthy, 20 P-III-B and 25 P-III-C participants were enrolled. Read more about this study
- Who is it for?
- Ages 23 to 51 yearsHealthy volunteers can take part
- Conditions the study is for
- Periodontal Health, Periodontitis
- What is being tested?
- Non-surgically performed scaling and root planing
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 65 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 23 Jan 2019to 24 Jul 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 23 to 51 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, periodontitis stage III grade B and C diagnoses
Who cannot join
- having any diagnosed medical disorders such as diabetes mellitus, cardiovascular diseases, rheumatoid arthritis, immunological and mucocutaneous diseases
- usage of antibiotics, non-steroidal anti-inflammatory drugs and immunosuppressive agents within the past 6 months
- having any non-inflammatory destructive periodontal disease
- nonsurgical/surgical periodontal therapy received in the past year
- pregnant/ lactating/ postmenopausal females.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Marmara University, Faculty of Dentistry, Department of Periodontology
Istanbul
About this study
Official title: Effect of Non-Surgical Periodontal Therapy on Salivary and Serum Biomarkers in Stage III Grade B and C Periodontitis
The present study aimed to assess the effect of non-surgical periodontal treatment on serum and salivary MMP-8, MAF, MIP-1α, M-CSF, and IL34 levels in periodontitis stage III grade B (P-III-B) and C (P-III-C) patients. 20 periodontally healthy, 20 P-III-B and 25 P-III-C participants were enrolled. At baseline, serum and saliva samples were collected and the whole mouth clinical periodontal parameters were recorded. Periodontitis patients received non-surgical periodontal treatment. Clinical parameters were re-measured and samples were re-collected at 1 and 3 months after treatment. Serum and salivary MMP-8, MAF, MIP-1α, M-CSF, and IL34 levels were analyzed by ELISA. Data were analyzed using appropriate statistical tests.
Read the detailed description
Periodontal disease is an inflammatory process that can result in tooth loss and also is considered a modifying factor for systemic health. Matrix metalloproteinase (MMP)-8 is the major collagenase of periodontal tissue breakdown. Macrophage-activating factor (MAF) can activate macrophages. M-CSF is known to modulate disease and inflammation and to play an important role in bone destruction. IL-34 shares vital functions of M-CSF, and manages myeloid cell survival, differentiation, and proliferation.
This study is the first controlled clinical study that examines the levels of MIP-1α, MAF, MMP-8, M-CSF, IL-34 in saliva and serum in two different periodontitis, and evaluates the situation before and after the treatment. The first hypothesis of this study; in periodontitis group, salivary and serum MIP-1α, MAF, MMP-8, M-CSF, IL-34 levels will be high, in contrast to the periodontal healthy group. The second hypothesis of this study is that after periodontal treatment, saliva and serum MIP-1α, MAF, MMP-8, M-CSF, IL-34 levels will decrease. Based on these hypotheses, the aim of the study is; to compare the levels of MIP-1a, MAF, MMP-8, M-CSF, IL-34 in saliva and serum of healthy controls, P-III-B, and P-III-C subjects and to evaluate the effect of periodontal treatment.
A total of 65 systemically healthy patients; 20 periodontally healthy, 20 P-III-B, 25 P-III-C were included in this study. The whole mouth clinical periodontal examination included measurement of probing depth (PPD), clinical attachment level (CAL), presence of bleeding on probing (BOP), gingival index (GI), and plaque index (PI) at 6 sites per tooth, except the third molars. The presence and type of the alveolar bone loss were assessed on the digital panoramic radiograph in each participant, which was supplemented with periapical radiographs if necessary.
Periodontal status of each patient was evaluated by a single calibrated periodontists 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=20) 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. Healthy group also exhibited no history of periodontitis. The periodontitis stage III patients had a minimum three teeth apart from the first molars and incisors showing CAL ≥5 mm and PD ≥6 mm and showed no>4 teeth loss because of periodontitis. Radiographic bone loss extending 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=20). If higher than 1.0, the patients were assigned to grade C (n=25)
Treatment
The recruited periodontitis patients received conventional quadrant 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 SRP. No periodontal intervention was carried out in the periodontally healthy controls.
Saliva and Serum Sampling A total of 5 mL of unstimulated whole saliva was collected by passive drool method between 9:00 and 10:00 am. The participants were advised to avoid food consumption for three hours before sample collection. The participants were seated upright and saliva was collected over a period of 5 minutes with instructions to pool saliva in the floor of the mouth and passively drool it into a sterile glass beaker. Then saliva samples are immediately transferred to a 2 mL polypropylene tube and stored at -80°C. 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 and storage at -80°C.
Biomarker Immunoassays 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. Serum and salivary samples of MMP-8 , M-CSF*, MIP-1α*, MAF , IL-34 in 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, 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, Mann-Whitney U test for normally and non-normally disturbed data. The Spearman's rank correlation test was used to detect the correlations of biochemical parameters with clinical parameters and each others in diseased group before and after treatment. All tests were performed at significance level of P <0.05.
- Conditions
- Periodontal Health, Periodontitis
- Being tested
- Non-surgically performed scaling and root planing
- 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-surgically performed scaling and root planingProcedure or surgery
Treatment of patients with periodontitis was performed using manual and ultrasonic instruments.
| Study group | Role | What they receive |
|---|---|---|
| Periodontal healthy | No intervention | Not described |
| Periodontitis Stage III Grade B | Active comparator | The patients were subjected to quadrant-wise full-mouth subgingival scaling and root planning 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-surgically performed scaling and root planing |
| Periodontitis Stage III Grade C | Active comparator | The patients were subjected to quadrant-wise full-mouth subgingival scaling and root planning 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-surgically performed scaling and root planing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Salivary MMP-8 (ng/ml) level
change in salivary MMP-8 levels from baseline to 1 month and 3 months after treatment
Measured: baseline to 1 month and 3 months after treatment
Salivary MAF (ng/ml) level
change in salivary MAF levels from baseline to 1 month and 3 months after treatment
Measured: baseline to 1 month and 3 months after treatment
Salivary MIP-1α (pg/ml) level
change in salivary MIP-1α levels from baseline to 1 month and 3 months after treatment
Measured: baseline to 1 month and 3 months after treatment
Salivary M-CSF (pg/ml) level
change in salivary M-CSF levels from baseline to 1 month and 3 months after treatment
Measured: baseline to 1 month and 3 months after treatment
Salivary IL-34 (pg/ml) level
change in salivary M-CSF levels from baseline to 1 month and 3 months after treatment
Measured: baseline to 1 month and 3 months after treatment
Secondary outcomes (5)
Serum MMP-8 (ng/ml) level
change in serum MMP-8 levels from baseline to 1 month and 3 months after treatment
Measured: baseline to 1 month and 3 months after treatment
Serum MAF /ng/ml) level
change in serum MAF levels from baseline to 1 month and 3 months after treatment
Measured: baseline to 1 month and 3 months after treatment
Serum MIP-1α (pg/ml) level
change in serum MIP-1α levels from baseline to 1 month and 3 months after treatment
Measured: baseline to 1 month and 3 months after treatment
Serum M-CSF (pg/ml) level
change in serum M-CSF levels from baseline to 1 month and 3 months after treatment
Measured: baseline to 1 month and 3 months after treatment
Serum IL-34 (pg/ml) level
change in serum IL-34 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 posted16 Aug 2021
- Study start23 Jan 2019
- Primary completion24 Jul 2020
- Study completion24 Jul 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
- 65 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
- NCT05005923
- Sponsor's protocol ID
- SAG-A-230119-0014
- Status last verified
- Aug 2021
- First submitted
- 29 Jul 2021
- Last updated
- 16 Aug 2021
- 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 16 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Non-Surgical Periodontal Therapy on Salivary and Serum Biomarkers in Stage III Grade B and C Periodontitis
- ClinicalTrials.gov ID
- NCT05005923
- Acronym / sponsor ID
- SAG-A-230119-0014
- Conditions
- Periodontal Health, Periodontitis
- Keywords
- periodontitis, periodontal treatment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 65 participants (actual)
- Lead sponsor
- Marmara UniversityUniversity, hospital or other
- Study start
- 23 Jan 2019 (actual)
- Primary completion
- 24 Jul 2020 (actual)
- Study completion
- 24 Jul 2020 (actual)
- First posted
- 16 Aug 2021 (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 serum and salivary MMP-8, MAF, MIP-1α, M-CSF, and IL34 levels in periodontitis stage III grade B (P-III-B) and C (P-III-C) patients. 20 periodontally healthy, 20 P-III-B and 25 P-III-C participants were enrolled. At baseline, serum and saliva samples were collected and the whole mouth clinical periodontal parameters were recorded. Periodontitis patients received non-surgical periodontal treatment. Clinical parameters were re-measured and samples were re-collected at 1 and 3 months after treatment. Serum and salivary MMP-8, MAF, MIP-1α, M-CSF, and IL34 levels were analyzed by ELISA. Data were analyzed using appropriate statistical tests.
Detailed description
Periodontal disease is an inflammatory process that can result in tooth loss and also is considered a modifying factor for systemic health. Matrix metalloproteinase (MMP)-8 is the major collagenase of periodontal tissue breakdown. Macrophage-activating factor (MAF) can activate macrophages. M-CSF is known to modulate disease and inflammation and to play an important role in bone destruction. IL-34 shares vital functions of M-CSF, and manages myeloid cell survival, differentiation, and proliferation.
This study is the first controlled clinical study that examines the levels of MIP-1α, MAF, MMP-8, M-CSF, IL-34 in saliva and serum in two different periodontitis, and evaluates the situation before and after the treatment. The first hypothesis of this study; in periodontitis group, salivary and serum MIP-1α, MAF, MMP-8, M-CSF, IL-34 levels will be high, in contrast to the periodontal healthy group. The second hypothesis of this study is that after periodontal treatment, saliva and serum MIP-1α, MAF, MMP-8, M-CSF, IL-34 levels will decrease. Based on these hypotheses, the aim of the study is; to compare the levels of MIP-1a, MAF, MMP-8, M-CSF, IL-34 in saliva and serum of healthy controls, P-III-B, and P-III-C subjects and to evaluate the effect of periodontal treatment.
A total of 65 systemically healthy patients; 20 periodontally healthy, 20 P-III-B, 25 P-III-C were included in this study. The whole mouth clinical periodontal examination included measurement of probing depth (PPD), clinical attachment level (CAL), presence of bleeding on probing (BOP), gingival index (GI), and plaque index (PI) at 6 sites per tooth, except the third molars. The presence and type of the alveolar bone loss were assessed on the digital panoramic radiograph in each participant, which was supplemented with periapical radiographs if necessary.
Periodontal status of each patient was evaluated by a single calibrated periodontists 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=20) 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. Healthy group also exhibited no history of periodontitis. The periodontitis stage III patients had a minimum three teeth apart from the first molars and incisors showing CAL ≥5 mm and PD ≥6 mm and showed no>4 teeth loss because of periodontitis. Radiographic bone loss extending 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=20). If higher than 1.0, the patients were assigned to grade C (n=25)
Treatment
The recruited periodontitis patients received conventional quadrant 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 SRP. No periodontal intervention was carried out in the periodontally healthy controls.
Saliva and Serum Sampling A total of 5 mL of unstimulated whole saliva was collected by passive drool method between 9:00 and 10:00 am. The participants were advised to avoid food consumption for three hours before sample collection. The participants were seated upright and saliva was collected over a period of 5 minutes with instructions to pool saliva in the floor of the mouth and passively drool it into a sterile glass beaker. Then saliva samples are immediately transferred to a 2 mL polypropylene tube and stored at -80°C. 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 and storage at -80°C.
Biomarker Immunoassays 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. Serum and salivary samples of MMP-8 , M-CSF*, MIP-1α*, MAF , IL-34 in 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, 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, Mann-Whitney U test for normally and non-normally disturbed data. The Spearman's rank correlation test was used to detect the correlations of biochemical parameters with clinical parameters and each others in diseased group before and after treatment. All tests were performed at 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 |
|---|---|---|
| Periodontal healthy | No intervention | – |
| Periodontitis Stage III Grade B | Active comparator | Procedure: Non-surgically performed scaling and root planingThe patients were subjected to quadrant-wise full-mouth subgingival scaling and root planning under local anesthesia. The entire non-surgical periodontal treatment of periodontitis groups was completed in a total of 4 sessions in two weeks. |
| Periodontitis Stage III Grade C | Active comparator | Procedure: Non-surgically performed scaling and root planingThe patients were subjected to quadrant-wise full-mouth subgingival scaling and root planning 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
- 23 to 51 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, periodontitis stage III grade B and C diagnoses
Key exclusion criteria (5 listed)
- having any diagnosed medical disorders such as diabetes mellitus, cardiovascular diseases, rheumatoid arthritis, immunological and mucocutaneous diseases
- usage of antibiotics, non-steroidal anti-inflammatory drugs and immunosuppressive agents within the past 6 months
- having any non-inflammatory destructive periodontal disease
- nonsurgical/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-surgically performed scaling and root planingTreatment of patients with periodontitis was performed using manual and ultrasonic instruments. | Procedure or surgery | Periodontitis Stage III Grade B, Periodontitis Stage III Grade C |
Primary outcome
Salivary MMP-8 (ng/ml) level
Time frame: baseline to 1 month and 3 months after treatment
change in salivary MMP-8 levels from baseline to 1 month and 3 months after treatment
Salivary MAF (ng/ml) level
Time frame: baseline to 1 month and 3 months after treatment
change in salivary MAF levels from baseline to 1 month and 3 months after treatment
Salivary MIP-1α (pg/ml) level
Time frame: baseline to 1 month and 3 months after treatment
change in salivary MIP-1α levels from baseline to 1 month and 3 months after treatment
Salivary M-CSF (pg/ml) level
Time frame: baseline to 1 month and 3 months after treatment
change in salivary M-CSF levels from baseline to 1 month and 3 months after treatment
Salivary IL-34 (pg/ml) level
Time frame: baseline to 1 month and 3 months after treatment
change in salivary M-CSF levels from baseline to 1 month and 3 months after treatment
5 secondary outcomes
Serum MMP-8 (ng/ml) level
Time frame: baseline to 1 month and 3 months after treatment
Serum MAF /ng/ml) level
Time frame: baseline to 1 month and 3 months after treatment
Serum MIP-1α (pg/ml) level
Time frame: baseline to 1 month and 3 months after treatment
Serum M-CSF (pg/ml) level
Time frame: baseline to 1 month and 3 months after treatment
Serum IL-34 (pg/ml) level
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 16 Aug 2021.
- 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-surgically performed scaling and root planing 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 16 Aug 2021. 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?
Salivary MMP-8 (ng/ml) level (time frame: baseline to 1 month and 3 months after treatment). The study lists 5 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 16 Aug 2021.