Actively Recruiting
Assessment of Pro-Resolution Mediator Levels in Periodontitis Stage III and IV Before and After Periodontal Therapy
Led by Cairo University · Updated on 2025-01-23
22
Participants Needed
2
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the levels of pro-resolution mediators, which are substances that help resolve inflammation, in people with Stage III and IV periodontitis compared to healthy individuals. Periodontitis is a chronic inflammatory disease that slowly damages the tissues supporting teeth, possibly leading to tooth loss and other health problems. This study aims to improve understanding of how these mediators affect inflammation and healing during periodontal therapy. The study involves a non-surgical periodontal therapy called professional mechanical plaque control, which includes motivating patients to improve oral hygiene, removing plaque and calculus professionally, adjusting faulty dental restorations, and teaching brushing and interdental cleaning techniques. Participants include those with advanced periodontitis and a control group of healthy patients. The design compares levels of pro-resolution mediators before and after treatment in the periodontitis group and against the healthy controls. Participants will have their gums checked and fluid samples taken at multiple times: before treatment, one day, one month, and three months after therapy. Researchers will measure inflammatory markers like lipoxin A4 and other clinical signs such as probing depth, bleeding on probing, plaque levels, attachment loss, and the number of healed pockets. The study uses randomized assignment and triple masking to ensure unbiased results and will last from the start of treatment through three months post-treatment.
CONDITIONS
Brief Title
Assessment of Pro-Resolution Mediator Levels in Periodontitis Stage III and IV Before and After Periodontal Therapy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 to 80 years
- Diagnosed with Stage III or IV periodontitis characterized by significant attachment loss and probing depths of 6 mm or more
- Vertical bone loss of 3 mm or more
- Tooth loss due to periodontitis of 4 or fewer teeth for Stage III and 5 or more teeth for Stage IV
- Furcation involvement Class II or III or moderate ridge defect
- Systemically healthy patients for the healthy control group aged 16 to 80 years
- Healthy controls must have at least 20 teeth, less than 10% bleeding sites with probing depths of 3 mm or less, and no signs of gum inflammation such as erythema or swelling
You will not qualify if you...
- Pregnancy or breastfeeding
- Smoking more than 20 cigarettes per day
- Immuno-inflammatory conditions affecting skin or oral mucosa
- Systemic diseases affecting bone turnover or periodontal health such as endocrine, connective tissue diseases, or use of bisphosphonate therapy
- Gastrointestinal diseases related to nutrition and mineral metabolism
- Periodontal or orthodontic treatment within 6 months prior to study start
- Use of anti-inflammatory or antimicrobial drugs within 3 months before sampling
AI-Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 1 day
Participants undergo assessments to measure pro-resolution mediator levels and periodontal health before treatment.
1 visit (in-person)
Duration - Single session with follow-up monitoring up to 3 months
Participants with periodontitis receive professional mechanical plaque control including oral hygiene instructions, plaque removal, and adjustment of restorations.
1 treatment visit and follow-up visits at 1 day, 1 month, and 3 months post-treatment
Duration - Up to 3 months
Participants are monitored to assess changes in periodontal health and pro-resolution mediator levels after treatment.
Follow-up visits at 1 day, 1 month, and 3 months post-treatment
Trial Site Locations
Total: 2 locations
1
Faculty of Dentistry-Cairo University
Manial, Cairo Governorate, Egypt, 12311
Actively Recruiting
2
faculty of dentistry Cairo university
Cairo, Egypt
Actively Recruiting
Research Team
H
Husam Ghazi Alharbi, Master Degree
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
SINGLE_GROUP
Primary Purpose
DIAGNOSTIC
Number of Arms
2
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