GCF Levels of Chemokines in Periodontitis

Periodontal Diseases Clinical Trial

Official title:

CCL19/MIP3beta and CCL20/MIP3alpha Levels in the Gingival Crevicular Fluid of the Patients With Stage III Grade B and C Periodontitis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06291454
• Other study ID #: 741100
• Status: Completed
• Start date: January 1, 2023
• Est. completion date: December 1, 2023

Study information

• Verified date: March 2024
• Source: T.C. ORDU ÜNIVERSITESI
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

This study aimed to determine CCL19/MIP3beta(β) and CCL20/MIP3alpha(α) in the gingival crevicular fluid (GCF) of the patients with different periodontitis phenotypes.

A total of 72 individuals, 24 with Stage III Grade B periodontitis (Group 1), 24 with Stage III Grade C periodontitis (Group 2), and 24 periodontally healthy (control group) (Group 3), were included in the study. GCF and clinical periodontal parameters were obtained at baseline. MIP3β and MIP3α levels in GCF were determined by ELISA.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 72
• Est. completion date: December 1, 2023
• Est. primary completion date: December 1, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 22 Years to 55 Years

Eligibility

Inclusion Criteria:

• Have at least 20 natural teeth, excluding third molars.

• Periodontitis patients had at least two non-adjacent sites per quadrant with probing depth (PD) = 5 mm and clinical attachment level (CAL) = 5 mm with gingival inflammation, and alveolar bone loss affecting >30% of the teeth, as detected on clinical and radiographical examinations.

• Periodontally healthy control group had no sign of gingival inflammation, no PD > 3mm and no evidence of attachment or bone loss

Exclusion Criteria:

• History of systemic disease.

• Regular use of any drugs which can effect the immune system or inflammatory response in the 6 months preceding the start of the study.

• Periodontal treatment during last 6 months that could affect periodontal status.

• Smoking.

• History of radiotherapy or chemotherapy.

• Current pregnancy, lactation or menopause.

Related Conditions & MeSH terms

• Periodontal Diseases
• Periodontitis

Intervention

Diagnostic Test:
• Routine periodontal examination
In all of the patients, the following indexes were used routinely for the periodontal examination: Sillness-Löe's plaque index (PI) (Silness & Löe, 1964), Löe-Sillness's gingival index (GI)(Löe & Silness, 1963), probing depth (PD) to measure the extent and severity of periodontal disease, clinical attachment level (CAL), and bleeding on probing (BOP)(Ainamo & Bay, 1975) to determine activity. In addition, routine radiographic evaluations were performed to determine bone levels.GCF samples were collected using standardized filter papers.

Locations

Country	Name	City	State
Turkey	Ordu University, Faculty of Dentistry	Ordu

Sponsors (1)

Lead Sponsor	Collaborator
T.C. ORDU ÜNIVERSITESI

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	CCL19/MIP3beta(ß) levels	CCL19/MIP3beta(ß) levels in the gingival crevicular fluid (GCF) of the all groups	Baseline
Primary	CCL20/MIP3alpha(a) levels	CCL20/MIP3alpha(a) levels in the gingival crevicular fluid (GCF)	Baseline
Secondary	CCL19/MIP3beta(ß) levels and clinical parameters	Correlation between CCL19/MIP3beta(ß) levels in the gingival crevicular fluid (GCF) of the all groups and all clinical parameters	Baseline
Secondary	CCL20/MIP3alpha(a) levels and clinical parameters	Correlation between CCL20/MIP3alpha(a) levels in the gingival crevicular fluid (GCF) of the all groups and all clinical parameters	Baseline