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

ConditionPeriodontitis
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
AgeNot listed
SponsorNational and Kapodistrian University of Athens

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

None

Trial design

Design model

Parallel

Treatments tested in this trial

  • Scaling and Root Planing

    Procedure/Surgery

    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/Surgery

    air flow-based mechanical debridement with erythritol powder

Treatment groups

75 Participants
are divided into 5 treatment groups
Group A: Full-Mouth SRPExperimental treatment 1 intervention
Group B: SRP + AntibioticsExperimental treatment 2 interventions
Group C: SRP + LaserExperimental treatment 2 interventions
Group D: SRP + Air PolishingExperimental treatment 2 interventions
Group E: Quadrant SRP (Control)Active comparator 1 intervention

Trial outcomes

Primary outcomes

1

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

For hs-CRP, blood would be collected: * Before each periodontal session * 24 hours after each periodontal session * 7 days after each periodontal session

Time frame
Baseline-7 days after the last periodontal session

Secondary outcomes

1

Changes in serum Interleukin 6 (IL-6)

For IL-6, blood would be collected: * Before each periodontal session * 24 hours after each periodontal session * 7 days after each periodontal session

Time frame
Baseline-7 days after the last periodontal session
2

Presence and load of bacteremia

culture, PCR, 16S rRNA sequencing

Time frame
Baseline-15 minutes after the last periodontal session
3

Changes in mean Clinical Attachment Level (CAL)

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.

Time frame
Baseline-8 weeks after the last periodontal session
4

Salivary CRP correlation with serum CRP

saliva CRP levels will be assessed and compared to serum

Time frame
Baseline-7 days after the last periodontal session

Other outcomes

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