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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).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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

Other trials in Turkey (Türkiye)

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.

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 groups in NCT05005923
Study groupRoleWhat they receive
Periodontal healthyNo interventionNot described
Periodontitis Stage III Grade BActive comparatorThe 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 CActive comparatorThe 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.

  1. 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

  2. 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

  3. 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

  4. 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

  5. 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)
  1. 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

  2. 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

  3. 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

  4. 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

  5. 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.

  1. First posted16 Aug 2021
  2. Study start23 Jan 2019
  3. Primary completion24 Jul 2020
  4. Study completion24 Jul 2020

Resources

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)
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

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.

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