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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

75 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-08-25

Study Completion Date

2027-12-15

Brief Summary

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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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Detailed Description

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Conditions

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Periodontitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Full-Mouth SRP

oral hygiene instructions and full mouth scaling and root planing in 24 hours. Clinical re-evaluation in 8 weeks.

Group Type EXPERIMENTAL

Scaling and Root Planing

Intervention Type PROCEDURE

Mechanical debridement of tooth surfaces using hand and ultrasonic instruments

SRP + Antibiotics

oral hygiene instructions and full mouth scaling and root planing in 24 hours along with antibiotic prophylaxis. Clinical re-evaluation in 8 weeks.

Group Type EXPERIMENTAL

Scaling and Root Planing

Intervention Type PROCEDURE

Mechanical debridement of tooth surfaces using hand and ultrasonic instruments

antibiotic prophylaxis

Intervention Type DRUG

2g Amoxicillin given 1 hour prior to instrumentation

SRP + Laser

oral hygiene instructions and 810nm diode laser at the base of the gingival sulcus/pocket following by full mouth scaling and root planing in 24 hours. Clinical re-evaluation in 8 weeks.

Group Type EXPERIMENTAL

Scaling and Root Planing

Intervention Type PROCEDURE

Mechanical debridement of tooth surfaces using hand and ultrasonic instruments

810nm Diode Laser

Intervention Type DEVICE

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

SRP + Air Polishing

oral hygiene instructions and air polishing following by full mouth scaling and root planing in 24 hours. Clinical re-evaluation in 8 weeks.

Group Type EXPERIMENTAL

Scaling and Root Planing

Intervention Type PROCEDURE

Mechanical debridement of tooth surfaces using hand and ultrasonic instruments

Air Polishing

Intervention Type PROCEDURE

air flow-based mechanical debridement with erythritol powder

Quadrant SRP (Control)

Oral hygiene instructions, scaling and root planing per quadrant with an interval of 7 days per session. Clinical re-evaluation in 8 weeks after last session.

Group Type ACTIVE_COMPARATOR

Scaling and Root Planing

Intervention Type PROCEDURE

Mechanical debridement of tooth surfaces using hand and ultrasonic instruments

Interventions

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Scaling and Root Planing

Mechanical debridement of tooth surfaces using hand and ultrasonic instruments

Intervention Type PROCEDURE

antibiotic prophylaxis

2g Amoxicillin given 1 hour prior to instrumentation

Intervention Type DRUG

810nm Diode Laser

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

Intervention Type DEVICE

Air Polishing

air flow-based mechanical debridement with erythritol powder

Intervention Type PROCEDURE

Eligibility Criteria

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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.

Eligible Sex

ALL

Accepts Healthy Volunteers

No