Impact of Non Surgical Periodontal Therapy on Cystatin C Levels

NCT07103421 | Completed DMC

• 1 other identifier: Tishreen U _ periodontic
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Periodontitis, Chronic Kidney Disease

Keywords

Non-Surgical Periodontal Therapy, Cystatin C, periodontis, Renal biomarkers

Outcome Measures

Primary Outcomes (1)

• Change in Cystatin C levels after 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.

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

Other Outcomes (3)

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

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

• Change in oral health-related quality of life indicators

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

• Effect of Periodontal Therapy on Renal Markers

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

Study Arms (3)

Healthy controls

NO INTERVENTION

10 systemically and periodontally healthy patients who will not receive any periodontal treatment. Cystatin C levels will be measured at baseline.

Periodontitis patients

EXPERIMENTAL

10 patients with periodontitis but no systemic diseases who will receive Non-Surgical Periodontal Therapy (scaling and root plannong). Cystatin C levels will be measured before and after treatment.

Diagnostic Test: Non-Surgical Periodontal Therapy

Periodontitis with CKD

EXPERIMENTAL

10 patients with periodontitis and 1-3 chronic kidney disease who will receive non-surgical periodontal therapy. Cystatin C levels and renal function will be monitored.

Diagnostic Test: Non-Surgical Periodontal Therapy

Interventions

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.

Periodontitis patients; Periodontitis with CKD

Eligibility Criteria

• Age: 20 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• \- 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.

Sponsors & Collaborators

• Tishreen University: lead

Study Sites (1)

Tishreen University - faculty of Dentistry

Latakia, Syria

Location

MeSH Terms

Conditions

Periodontitis; Renal Insufficiency, Chronic

Condition Hierarchy (Ancestors)

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

Study Officials

• Hashm Daoud, Prof

  Tishreen University, faculty of Dentistry

  STUDY CHAIR

• Nebras Naddaf, Phd's student

  Tishreen University, faculty of Dentistry

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Three parallel groups: healthy controls, periodontis patients without systemic disease, and periodontis patients with chronic kidney disease.

Study Record Dates

• First Submitted: July 24, 2025
• First Posted: August 5, 2025
• Study Start: May 12, 2023
• Primary Completion: June 10, 2024
• Study Completion: July 1, 2025
• Last Updated: August 5, 2025

Record last verified: 2025-08

Locations

SY (1)