Impact of Non Surgical Periodontal Therapy on Cystatin C Levels

NCT ID: NCT07103421

Last Updated: 2025-08-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-05-12
• Study Completion Date: 2025-07-01

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.

Detailed Description

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).

Conditions

Periodontitis, Chronic Kidney Disease

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

Healthy controls

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Periodontitis patients

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.

Group Type: EXPERIMENTAL

Non-Surgical Periodontal Therapy

Intervention Type: 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 with CKD

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.

Group Type: EXPERIMENTAL

Non-Surgical Periodontal Therapy

Intervention Type: 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.

Interventions

Non-Surgical Periodontal Therapy

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.

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

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.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Tishreen University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Hashm Daoud, Prof

Role: STUDY_CHAIR

Tishreen University, faculty of Dentistry

Nebras Naddaf, Phd's student

Role: PRINCIPAL_INVESTIGATOR

Tishreen University, faculty of Dentistry

Locations

Tishreen University - faculty of Dentistry

Latakia, , Syria

Countries

Syria

Other Identifiers

Tishreen U _ periodontic

Identifier Type: -

Identifier Source: org_study_id