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

NCT07077122 | Recruiting

• 2 other identifiers: 688/11.02.2025Ethics committee
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

Brief Summary

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. 1.bacteremia
2. 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.

Conditions

Periodontitis

Keywords

periodontitis; inflammatory markers; non-surgical periodontal therapy; bacteremia

Outcome Measures

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

  Baseline-7 days after the last periodontal session

Secondary Outcomes (15)

• Changes in serum Interleukin 6 (IL-6)

  Baseline-7 days after the last periodontal session

• Presence and load of bacteremia

  Baseline-15 minutes after the last periodontal session

• Changes in mean Clinical Attachment Level (CAL)

  Baseline-8 weeks after the last periodontal session

• Salivary CRP correlation with serum CRP

  Baseline-7 days after the last periodontal session

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

  Baseline-7 days after the last periodontal session

Study Arms (5)

Full-Mouth SRP

EXPERIMENTAL

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

Procedure: Scaling and Root Planing

SRP + Antibiotics

EXPERIMENTAL

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

Procedure: Scaling and Root Planing; Drug: antibiotic prophylaxis

SRP + Laser

EXPERIMENTAL

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.

Procedure: Scaling and Root Planing; Device: 810nm Diode Laser

SRP + Air Polishing

EXPERIMENTAL

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

Procedure: Scaling and Root Planing; Procedure: Air Polishing

Quadrant SRP (Control)

ACTIVE COMPARATOR

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.

Procedure: Scaling and Root Planing

Interventions

Scaling and Root Planing PROCEDURE

Mechanical debridement of tooth surfaces using hand and ultrasonic instruments

Full-Mouth SRP; Quadrant SRP (Control); SRP + Air Polishing; SRP + Antibiotics; SRP + Laser

antibiotic prophylaxis DRUG

2g Amoxicillin given 1 hour prior to instrumentation

SRP + Antibiotics

810nm Diode Laser DEVICE

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

SRP + Laser

Air Polishing PROCEDURE

air flow-based mechanical debridement with erythritol powder

SRP + Air Polishing

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

Sponsors & Collaborators

• National and Kapodistrian University of Athens: lead

Study Sites (1)

Department of Periodontology, Dental School of Athens

Athens, Greece

RECRUITING

Related Publications (3)

• Sanz M, Marco Del Castillo A, Jepsen S, Gonzalez-Juanatey JR, D'Aiuto F, Bouchard P, Chapple I, Dietrich T, Gotsman I, Graziani F, Herrera D, Loos B, Madianos P, Michel JB, Perel P, Pieske B, Shapira L, Shechter M, Tonetti M, Vlachopoulos C, Wimmer G. Periodontitis and cardiovascular diseases: Consensus report. J Clin Periodontol. 2020 Mar;47(3):268-288. doi: 10.1111/jcpe.13189. Epub 2020 Feb 3.

  PMID: 32011025 BACKGROUND

• Sanz M, Herrera D, Kebschull M, Chapple I, Jepsen S, Beglundh T, Sculean A, Tonetti MS; EFP Workshop Participants and Methodological Consultants. Treatment of stage I-III periodontitis-The EFP S3 level clinical practice guideline. J Clin Periodontol. 2020 Jul;47 Suppl 22(Suppl 22):4-60. doi: 10.1111/jcpe.13290.

  PMID: 32383274 BACKGROUND

• Kinane DF, Riggio MP, Walker KF, MacKenzie D, Shearer B. Bacteraemia following periodontal procedures. J Clin Periodontol. 2005 Jul;32(7):708-13. doi: 10.1111/j.1600-051X.2005.00741.x.

  PMID: 15966875 BACKGROUND

MeSH Terms

Conditions

Periodontitis; Bacteremia

Interventions

Tooth Exfoliation; Root Planing; Antibiotic Prophylaxis; Lasers, Semiconductor

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Dental Physiological Phenomena; Digestive System and Oral Physiological Phenomena; Dental Scaling; Dental Prophylaxis; Periodontics; Dentistry; Subgingival Curettage; Preventive Dentistry; Chemoprevention; Drug Therapy; Therapeutics; Premedication; Lasers; Optical Devices; Equipment and Supplies; Radiation Equipment and Supplies

Study Officials

• Madianos Phoebus

  Professor

  STUDY CHAIR

Central Study Contacts

Zampa Evangelia

CONTACT

00306987027896; elina_zampa@windowslive.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator - DDS, MSc

Study Record Dates

• First Submitted: June 30, 2025
• First Posted: July 22, 2025
• Study Start: August 25, 2025
• Primary Completion (Estimated): July 15, 2027
• Study Completion (Estimated): December 15, 2027
• Last Updated: September 4, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will share
• Time Frame: After publication of the main study results.
• Access Criteria: Data will be available upon reasonable request to qualified researchers for academic purposes.

Locations

GR (1)