Assessment of Pro-Resolution Mediator Levels in Periodontitis Stage III and IV Before and After Periodontal Therapy

Overview

This study aims to assess Pro-Resolution Mediator levels during non-surgical periodontal therapy in individuals with Stage III and IV periodontitis, comparing them to healthy subjects. Periodontitis, a chronic inflammatory condition affecting tooth-supporting tissues, can lead to tooth loss and systemic complications. Understanding the role of pro-resolving lipid mediators in inflammation resolution may offer insights into therapeutic benefits associated with these mediators.

Detailed description

Periodontitis is a chronic inflammatory disease that affects the tooth-supporting tissues, it produces a slow destruction of the periodontium that may eventually result in tooth loss. Periodontitis is caused by a dysbiosis of the immune system where there is an imbalance between the processes that activate and terminate the inflammatory process.(Van Dyke, 2020) Pro-resolving lipid mediators (PMs) play a key role in actively resolving inflammation, modulating immune responses, and promoting tissue healing. However, the understanding of PMs in periodontitis and their role in the enduring nature of the disease has not been sufficiently studied in a clinical setting. It has been suggested that PM levels vary between periodontitis patients and healthy individual with periodontal therapy potentially restoring the balance between pro- and anti-inflammatory mediators. (Van Dyke, 2017) The study aims to provide insights into inflammation resolution mechanisms in periodontitis and the therapeutic potential of PMs.

This study aims to Assess Pro-Resolution Mediator Levels During Periodontal Therapy in Patients with Periodontitis Stage III and IV compared to healthy patients.

Hypothesis Null Hypothesis: pro-resolution mediators' level before and after non-surgical treatment in stage III and IV periodontitis compared to healthy patients, there will be no difference in level before and after non-surgical treatment between stage III and IV periodontitis compared to healthy patients.

Trial design:

The current study design is a before and after trial with a single (interventional) population measured before and after treatment compared to a negative control of healthy patients.

Interventions

• Procedure Professional mechanical plaque control
  thisThe first step in therapy is aimed at guiding behavior change by motivating the patient to undertake successful removal of supragingival dental biofilm and risk factor control and may include the following interventions: * Interventions to improve the effectiveness of oral hygiene \[motivation, instructions (oral hygiene instructions, OHI) * Professional mechanical plaque removal (PMPR), which includes the professional interventions aimed at removing supragingival plaque and calculus, as we

Primary outcome measures

• Change in level of GCF lipoxin A4 [Time frame: preoperative, one day, one month and 3 months postoperative]

Secondary outcome measures (6)

• Change in level of GCF Protectin [Time frame: preoperative, one day, one month and 3 months postoperative]
• Probing pocket depth (PPD) [Time frame: preoperative, and 3 months postoperative]
• Bleeding On Probing (BOP) [Time frame: preoperative, and 3 months postoperative]
• Plaque index (PI) [Time frame: preoperative, and 3 months postoperative]
• Clinical Attachment Level (CAL) [Time frame: preoperative, and 3 months postoperative]
• Number of pockets closed [Time frame: preoperative, and 3 months postoperative]

Eligibility criteria

Inclusion criteria

Inclusion criteria

• Adult patients above 18 years old.
• Interdental CAL at site of greatest loss ≥5 mm or extending to middle third of the root.
• Interdental CAL at site of greatest loss ≥8 mm or extending to apical third of the root.
• Probing depth ≥6 mm.
• Vertical bone loss ≥3 mm.
• Tooth loss due to periodontitis of ≤4 teeth. (Periodontitis Stage III)
• Tooth loss due to periodontitis of ≥5 teeth. (Periodontitis Stage IV)
• Furcation involvement Class II or III Moderate ridge defect.

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Exclusion criteria

• 1\. Pregnancy or lactation. 2. Smoking more than 20 cigarettes. 3. Immuno-inflammatory conditions of the skin and oral mucosa 4. systemic conditions affecting bone turnover and periodontal health status (e.g. endocrine and connective tissue diseases, bisphosphonate antiresorptive therapy, gastrointestinal diseases related to nutrition and mineral metabolism) 5. Periodontal or orthodontic treatment at least 6 months before the start of the study 6. Use of anti-inflammatory and antimicrobial agents within 3 months before sampling

Inclusion criteria for healthy group:

• Systemically healthy patients.
• Patients with an age range between 16 to 80 years.
• Patients have a minimum of 20 teeth.
• Less than 10% bleeding sites with probing depths ≤3 mm.
• absence of erythema, oedema.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Single group

Masking

Triple blind

Primary purpose

Diagnostic

Study locations

Egypt · 2 centers

• Faculty of Dentistry-Cairo University — Manial
• faculty of dentistry Cairo university — Cairo

Identifiers

NCT: NCT06789458 · 20042024PER7_2_2

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗