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NCT Number: NCT06789458

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

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.

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Key information

Conditions

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of Dentistry-Cairo University, Manial, Cairo Governorate, Egypt

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Professional mechanical plaque control

Procedure

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 well as possible plaque-retentive factors that impair oral hygiene practices.
  • Adjustment of faulty restoration and polishing
  • The mechanical plaque control instructions for each patient include brushing and interdental cleaning techniques.

Primary outcomes

  1. Change in level of GCF lipoxin A4

    Time frame: preoperative, one day, one month and 3 months postoperative

Secondary outcomes

  1. Change in level of GCF Protectin

    Time frame: preoperative, one day, one month and 3 months postoperative

  2. Probing pocket depth (PPD)

    Time frame: preoperative, and 3 months postoperative

  3. Bleeding On Probing (BOP)

    Time frame: preoperative, and 3 months postoperative

  4. Plaque index (PI)

    Time frame: preoperative, and 3 months postoperative

  5. Clinical Attachment Level (CAL)

    Time frame: preoperative, and 3 months postoperative

  6. Number of pockets closed

    Time frame: preoperative, and 3 months postoperative

Study contacts

Contact information is provided by the study sponsor or research team.

Husam Ghazi Alharbi, Master Degree

CONTACT

[email protected]

+201222284055 ext. +20

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Important dates

Study start
2022
Primary completion
2025
Study completion
2025
First posted
Jan 23, 2025
Registry last updated
Jan 23, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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