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NCT Number: NCT07103421

Impact of Non Surgical Periodontal Therapy on Cystatin C Levels

Study the effect of non-surgical periodontal therapy on cystatin C levels in gingival crevicular fluid and serum in both healthy patients and patients with renal impairment. The number of participants is 30 individuals, divided into three groups receiving conservative periodontal treatment (scaling and root planing):Systemically and periodontally healthy patients, Patients with periodontitis without systemic diseases, and Patients with periodontitis and chronic kidney disease. The study also aims to determine the relationship between the severity of periodontal disease and kidney function by measuring cystatin C levels, which is an important biomarker for both conditions. Additionally, it seeks to assess whether non-surgical periodontal therapy can be included in the treatment protocols for kidney patients to improve their quality of life.

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Key information

Conditions

Periodontitis, Chronic Kidney Disease Chronic Disease Disease Attributes Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Male Urogenital Diseases Mouth Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Periodontal Diseases Periodontitis Renal Insufficiency Renal Insufficiency, Chronic Stomatognathic Diseases Urogenital Diseases Urologic Diseases

Age range

20 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Tishreen University - faculty of Dentistry

Latakia, Syria

About this study

Periodontal diseases, particularly gingivitis and periodontitis, are common inflammatory conditions affecting the tooth-supporting tissues. These diseases induce both local and systemic inflammatory responses, which may impact other organs, including the kidneys. Cystatin C (CSTC) is an inhibitor of cysteine proteases and is considered an important biomarker for kidney function, as its serum levels rise in cases of renal impairment. Periodontal diseases may contribute to elevated serum cystatin C levels due to systemic inflammation caused by bacterial infection and inflammatory mediators circulating in the bloodstream. On the other hand, non-surgical periodontal therapy (e.g., scaling and root planing) may reduce both local and systemic inflammation, potentially improving cystatin C levels and kidney function. This study aims to: Assess and compare cystatin C levels in serum and gingival crevicular fluid (GCF) among healthy individuals and patients with periodontitis، Examine the effect of non-surgical periodontal therapy on serum and GCF cystatin C levels in patients with renal impairment compared to healthy controls، and Analyze the relationship between periodontitis severity and kidney function by correlating cystatin C levels with other renal markers (e.g., glomerular filtration rate).

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Patients with Stage II (Grade A or B) periodontitis (according to AAP 2017 classification).
  • Age range: 20 to 70 years.
  • No pathological tooth mobility.
  • No furcation involvement caused by periodontal disease.
  • No systemic diseases affecting periodontal or renal health.
  • No systemic antibiotic use within the previous 3 months.
  • No periodontal treatment within the previous 6 months

For Chronic Kidney Disease (CKD) Patients:

  • Confirmed CKD diagnosis for at least 3 years (by a consultant nephrologist).
  • Receiving conservative management (pre-dialysis).

Exclusion criteria

  • Stage III or IV periodontitis.
  • Grade C periodontal disease.
  • Bone loss in more than 10 sites.
  • Pathological tooth mobility (Grade II or III).
  • Furcation involvement due to periodontal disease.
  • Tooth loss due to periodontal disease.
  • Heavy smoking (>10 cigarettes/day).
  • Pregnancy or lactation.
  • Patients undergoing dialysis.

Treatment and study plan

Non-Surgical Periodontal Therapy

Diagnostic Test

Non-surgical periodontal therapy involves the removal of bacterial plaque and calculus from tooth surfaces and root surfaces beneath the gum line using manual or ultrasonic instruments. This treatment is performed for patients with periodontitis to improve gum health and reduce inflammation. Serum cystatin C levels will be compared before and after treatment between healthy patients and those with renal impairment.

Primary outcomes

  1. Change in Cystatin C levels after periodontal therapy

    Time frame: Baseline (before treatment) and 4 weeks after completion of periodontal therapy

    Comparison of serum Cystatin C concentration (mg/L) between baseline and 4 weeks post non-surgical periodontal treatment (scaling and root planing) in periodontitis patients with and without chronic kidney disease.

Other outcomes

  1. Improvement in periodontal clinical parameters after Non-Surgical therapy.

    Time frame: Baseline measurement (pre-treatment) and 4 weeks post-treatment completion

    Measurement of changes in clinical periodontal parameters (clinical attachment level CAL) at 4 sites per tooth, 4 weeks after non-surgical periodontal therapy (scaling and root planing) in systemically healthy periodontitis patients.

  2. Change in oral health-related quality of life indicators

    Time frame: Baseline measurement (pre-treatment) and 4 weeks follow-up

    Measurement of changes in OHI-s (Oral Hygiene Index simplified) to assess oral health-related quality of life before and after periodontal therapy across all study groups.

  3. Effect of Periodontal Therapy on Renal Markers

    Time frame: Baseline measurement (pre-treatment) and 4 weeks post-treatment completion

    Evaluation of changes in serum cystatin C levels in chronic kidney disease patients (stages 1-3) 4 weeks after non-surgical periodontal therapy.

Sponsors and collaborators

Lead sponsor

Latakia University

Other

Registry information

Official study title

Effect of Non-Surgical Periodontal Therapy on Cystatin C Levels in Healthy and Renal Impaired Patients

Important dates

Study start
2023
Primary completion
2024
Study completion
2025
First posted
Aug 5, 2025
Registry last updated
Aug 5, 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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