Periodontitis, Chronic Kidney DiseaseNCT07103421
Impact of Non Surgical Periodontal Therapy on Cystatin C Levels
A study testing Non-Surgical Periodontal Therapy in people with Periodontitis, Chronic Kidney Disease, run by Latakia University at 1 site in Syria.
Trial 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… Read more about this study
- Who is it for?
- Ages 20 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Periodontitis, Chronic Kidney Disease
- What is being tested?
- Non-Surgical Periodontal Therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteSyria
- Study dates
- 12 May 2023to 1 Jul 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
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- 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).
Who cannot join
- 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.
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- Heavy smoking (>10 cigarettes/day).
- Pregnancy or lactation.
- Patients undergoing dialysis.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Non-Surgical Periodontal Therapy on Cystatin C Levels in Healthy and Renal Impaired Patients
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.
Read the 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
- Being tested
- Non-Surgical Periodontal Therapy
- Keywords
- Non-Surgical Periodontal Therapy, Cystatin C, periodontis, Renal biomarkers
- Medical subject headings
- Periodontitis, Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non-Surgical Periodontal TherapyDiagnostic 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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Diagnostic Test: Non-Surgical Periodontal Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline (before treatment) and 4 weeks after completion of periodontal therapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2025
- Study start12 May 2023
- Primary completion10 Jun 2024
- Study completion1 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Periodontitis, Chronic Kidney DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Three parallel groups: healthy controls, periodontis patients without systemic disease, and periodontis patients with chronic kidney disease.
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Latakia University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hashm Daoud, Prof, Study chair, Tishreen University, faculty of DentistryNebras Naddaf, Phd's student, Principal investigator, Tishreen University, faculty of Dentistry
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07103421
- Sponsor's protocol ID
- Tishreen U _ periodontic
- Status last verified
- Aug 2025
- First submitted
- 24 Jul 2025
- Last updated
- 5 Aug 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Non-Surgical Periodontal Therapy on Cystatin C Levels in Healthy and Renal Impaired Patients
- ClinicalTrials.gov ID
- NCT07103421
- Acronym / sponsor ID
- Tishreen U _ periodontic
- Conditions
- Periodontitis, Chronic Kidney Disease
- Keywords
- Non-Surgical Periodontal Therapy, Cystatin C, periodontis, Renal biomarkers
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Latakia UniversityUniversity, hospital or other
- Study start
- 12 May 2023 (actual)
- Primary completion
- 10 Jun 2024 (actual)
- Study completion
- 1 Jul 2025 (actual)
- First posted
- 5 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Three parallel groups: healthy controls, periodontis patients without systemic disease, and periodontis patients with chronic kidney disease.
| Arm | Type | Receives |
|---|---|---|
| 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 | Diagnostic Test: Non-Surgical Periodontal Therapy10 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. |
| Periodontitis with CKD | Experimental | Diagnostic Test: Non-Surgical Periodontal Therapy10 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. |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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.
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Non-Surgical Periodontal TherapyNon-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. | Diagnostic test | Periodontitis patients, Periodontitis with CKD |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hashm Daoud, Prof study chair
Tishreen University, faculty of Dentistry
Nebras Naddaf, Phd's student principal investigator
Tishreen University, faculty of Dentistry
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Non-Surgical Periodontal Therapy in people with Periodontitis, Chronic Kidney Disease, run by Latakia University at 1 site in Syria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Syria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Cystatin C levels after periodontal therapy (time frame: Baseline (before treatment) and 4 weeks after completion of periodontal therapy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Aug 2025.