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NCT Number: NCT07077122

Evaluation of the Systemic Burden of Non-surgical Periodontal Therapy: A Randomized Clinical Trial on Five Different Treatment Protocols

Periodontitis is a chronic inflammatory disease of the periodontal tissues leading to the destruction of the tooth supporting structures. Despite the fact that periodontal bacteria are etiological agents, host susceptibility related to the inflammatory response to plaque bacteria is the main determinant of the development of periodontitis. Non-surgical periodontal therapy (NSPT) represents the base of any therapeutic approach. Its main component is the removal of bacterial deposits, i.e. soft biofilm or mineralized calculus, from the tooth surface via mechanical debridement.

It is well established that patients suffering from periodontitis present with a low-grade systemic inflammatory state when compared to healthy subjects. Increased concentrations of inflammatory biomarkers in systemic circulation, such as, C-reactive protein (CRP) and interleukin (IL)-6, have already been reported. A significant amount of evidence derived from epidemiological as well as experimental studies has implicated periodontitis as a putative risk factor for a number of systemic diseases, such as, cardiovascular diseases, diabetes and respiratory diseases having systemic low-grade inflammation as their underlying pathogenic mechanism. Furthermore, several intervention studies provide evidence that periodontal treatment may improve systemic inflammatory markers and potentially reduce the risk for cardio-metabolic diseases.

However, periodontal therapy may pose a transient, short-term health hazard immediately after instrumentation of the root surface presumably due to the spill of bacteria and their products in the systemic circulation and the subsequent acute inflammatory response. Positive bacteremia in NSPT ranges from 13% to 80.9% after mechanical debridement depending primarily on the periodontal status of the patient, but also on the study design and the microbiological methodology.

Finally, an important aspect concerning NSPT is method and duration of delivery. NSPT may be carried out with either hand instruments, power driven instruments, such as, ultrasonic and sonic or a "blended approach" using both. Besides these instruments, the adjunctive use of lasers or/and air powder technology has been proposed. Regarding duration, treatment may be staged over several visits with a quadrant approach, or with a full-mouth debridement approach, also referred to as an intensive treatment approach, which delivers complete debridement within 24 hours.

The aim of this clinical trial is to assess the immediate systemic burden of five different treatment protocols for the NSPT on:

1. bacteremia 2. serum inflammatory responses. Additionally, saliva CRP levels will be assessed and compared to serum. Moreover, the effectiveness of the treatment protocols on clinical periodontal parameters will be assessed.

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Key information

Conditions

Periodontitis Bacteremia Bacterial Infections Bacterial Infections and Mycoses Infections Inflammation Mouth Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Periodontal Diseases Sepsis Stomatognathic Diseases Systemic Inflammatory Response Syndrome

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Periodontology, Dental School of Athens

Athens, Greece

Location status: Recruiting

Location contact

Prof. Madianos P., DDS, PhD

CONTACT

[email protected]

00302107461181

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Periodontitis stage III or IV
  • Non-smokers or light smokers (<10 cigarettes/day)
  • No NSAIDs in regular basis or antibiotics 3 months before
  • No previous periodontal treatment 12 months before
  • No presence of other acute or chronic infections
  • No systemic disease or medication known to affect the serum level of inflammatory markers (cyclooxygenase inhibitors, platelet aggregation inhibitors, lipid lowering agents, â-adrenoreceptor antagonists, angiotensin converting enzyme inhibitors, antidiabetic agents, estrogen-based medications, medication for autoimmune disease, magnesium or vitamin E supplements)
  • No pregnancy or lactation
  • Written informed consent.

Treatment and study plan

Scaling and Root Planing

Procedure

Mechanical debridement of tooth surfaces using hand and ultrasonic instruments

Antibiotic Prophylaxis

Drug

2g Amoxicillin given 1 hour prior to instrumentation

810nm Diode Laser

Device

Laser applied at base of gingival pockets prior to mechanical debridement.

Air Polishing

Procedure

air flow-based mechanical debridement with erythritol powder

Primary outcomes

  1. Change in serum high-sensitivity C-reactive protein (hs-CRP) levels

    Time frame: Baseline-7 days after the last periodontal session

    For hs-CRP, blood would be collected:

    • Before each periodontal session
    • 24 hours after each periodontal session
    • 7 days after each periodontal session

Secondary outcomes

  1. Changes in serum Interleukin 6 (IL-6)

    Time frame: Baseline-7 days after the last periodontal session

    For IL-6, blood would be collected:

    • Before each periodontal session
    • 24 hours after each periodontal session
    • 7 days after each periodontal session

  2. Presence and load of bacteremia

    Time frame: Baseline-15 minutes after the last periodontal session

    culture, PCR, 16S rRNA sequencing

  3. Changes in mean Clinical Attachment Level (CAL)

    Time frame: Baseline-8 weeks after the last periodontal session

    CAL would be assessed before treatment initiation and would then be recorded at 8 weeks after the last periodontal session.

    All clinical measurements would be taken using a manual probe. CAL would be recorded at six sites per tooth. Third molars would be excluded from the measurements.

  4. Salivary CRP correlation with serum CRP

    Time frame: Baseline-7 days after the last periodontal session

    saliva CRP levels will be assessed and compared to serum

  5. Changes in serum Tumor Necrosis Factor a (TNF-a) levels

    Time frame: Baseline-7 days after the last periodontal session

    For changes in TNF-a levels, blood would be collected:

    • Before each periodontal session
    • 24 hours after each periodontal session
    • 7 days after each periodontal session

  6. Changes in Serum amyloid A (SAA) levels

    Time frame: Baseline-7 days after the last periodontal session

    For changes in SAA levels, blood would be collected:

    • Before each periodontal session
    • 24 hours after each periodontal session
    • 7 days after each periodontal session

  7. Changes in Serum cystatin c levels

    Time frame: Baseline-7 days after the last periodontal session

    For changes in serum cystatin c levels, blood would be collected:

    • Before each periodontal session
    • 24 hours after each periodontal session
    • 7 days after each periodontal session

  8. Changes in Matrix metalloproteinase-8 (MMP-8) levels

    Time frame: Baseline-7 days after the last periodontal session

    For changes in MMP-8 levels, blood would be collected:

    • Before each periodontal session
    • 24 hours after each periodontal session
    • 7 days after each periodontal session

  9. Changes in serum D-dimers levels

    Time frame: Baseline-7 days after the last periodontal session

    For changes in serum D-dimers levels, blood would be collected:

    • Before each periodontal session
    • 24 hours after each periodontal session
    • 7 days after each periodontal session

  10. Changes in serum Lipopolysaccharide (LPS) levels

    Time frame: Baseline-7 days after the last periodontal session

    For changes in serum LPS levels, blood would be collected:

    • Before each periodontal session
    • 24 hours after each periodontal session
    • 7 days after each periodontal session

  11. Changes in mean Pocket Depth (PD)

    Time frame: Baseline-8 weeks after the last periodontal session

    PD would be assessed before treatment initiation and would then be recorded at 8 weeks after the last periodontal session.

    All clinical measurements would be taken using a manual probe. PD would be recorded at six sites per tooth. Third molars would be excluded from the measurements.

  12. Changes in mean Gingival Recession (GR)

    Time frame: Baseline-8 weeks after the last periodontal session

    GR would be assessed before treatment initiation and would then be recorded at 8 weeks after the last periodontal session.

    All clinical measurements would be taken using a manual probe. GR would be recorded at six sites per tooth. Third molars would be excluded from the measurements.

  13. Changes in Full-Mouth Plaque Score (FMPS)

    Time frame: Baseline-8 weeks after the last periodontal session

    FMPS would be assessed before treatment initiation and would then be recorded at 8 weeks after the last periodontal session.

    All clinical measurements would be taken using a manual probe. FMPS would be recorded at six sites per tooth. Third molars would be excluded from the measurements.

  14. Changes in Full-Mouth Bleeding Score (FMBS)

    Time frame: Baseline-8 weeks after the last periodontal session

    FMBS would be assessed before treatment initiation and would then be recorded at 8 weeks after the last periodontal session. All clinical measurements would be taken using a manual probe. FMBS would be recorded at six sites per tooth. Third molars would be excluded from the measurements.

  15. Changes in simplified gingival index (s-GI)

    Time frame: Baseline-8 weeks after the last periodontal session

    s-GI would be assessed before treatment initiation and would then be recorded at 8 weeks after the last periodontal session. All clinical measurements would be taken using a manual probe. s-GI would be recorded at four sites per tooth. Third molars would be excluded from the measurements.

Study contacts

Contact information is provided by the study sponsor or research team.

Zampa Evangelia

CONTACT

[email protected]

00306987027896

Sponsors and collaborators

Lead sponsor

National and Kapodistrian University of Athens

Other

Registry information

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Jul 22, 2025
Registry last updated
Sep 4, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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