Assessing inflammation resolution in advanced gum disease treatment

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

This study is testing how a new treatment for advanced gum disease can help reduce inflammation and promote healing by looking at certain substances in patients compared to healthy people.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 22 (estimated)
• Ages: 18 Years to 80 Years
• Sex: All
• Sponsor: Cairo University (Academic / other)
• Locations: 2 sites (Manial, Cairo Governorate and 1 other locations)
• Trial ID: NCT06789458 on ClinicalTrials.gov

What this trial studies

This study evaluates the levels of pro-resolution mediators in patients with Stage III and IV periodontitis undergoing non-surgical periodontal therapy, comparing these levels to those in healthy individuals. Periodontitis is a chronic inflammatory disease that can lead to tooth loss and systemic health issues. The research aims to understand how pro-resolving lipid mediators influence inflammation resolution and tissue healing in the context of periodontal disease. By analyzing these mediators before and after treatment, the study seeks to provide insights into their therapeutic potential.

Who should consider this trial

Good fit: Ideal candidates include adults over 18 with Stage III or IV periodontitis and specific clinical criteria related to tooth loss and probing depth.

Not a fit: Patients with conditions such as pregnancy, smoking more than 20 cigarettes, or systemic diseases affecting periodontal health may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could enhance understanding of inflammation resolution in periodontal disease, potentially leading to improved treatment strategies.

How similar studies have performed: While the role of pro-resolution mediators in periodontal disease has been suggested, this specific approach has not been extensively tested in clinical settings.

Eligibility criteria

Inclusion Criteria:

Inclusion criteria:

1. Adult patients above 18 years old.
2. Interdental CAL at site of greatest loss ≥5 mm or extending to middle third of the root.
3. Interdental CAL at site of greatest loss ≥8 mm or extending to apical third of the root.
4. Probing depth ≥6 mm.
5. Vertical bone loss ≥3 mm.
6. Tooth loss due to periodontitis of ≤4 teeth. (Periodontitis Stage III)
7. Tooth loss due to periodontitis of ≥5 teeth. (Periodontitis Stage IV)
8. 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:

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

Where this trial is running

Manial, Cairo Governorate and 1 other locations

• Faculty of Dentistry-Cairo University — Manial, Cairo Governorate, Egypt (Recruiting)
• faculty of dentistry Cairo university — Cairo, Egypt (Recruiting)

Study contacts

• Study coordinator: Husam Ghazi Alharbi, Master Degree

Conditions Peridontal Disease; lipoxin; proresolution mediators