NCT06291454

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
72

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2023

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2023

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2023

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

February 22, 2024

Completed
11 days until next milestone

First Posted

Study publicly available on registry

March 4, 2024

Completed
Last Updated

March 8, 2024

Status Verified

March 1, 2024

Enrollment Period

11 months

First QC Date

February 22, 2024

Last Update Submit

March 6, 2024

Conditions

Periodontal Diseases

Outcome Measures

Primary Outcomes (2)

  • CCL19/MIP3beta(β) levels

    CCL19/MIP3beta(β) levels in the gingival crevicular fluid (GCF) of the all groups

    Baseline

  • CCL20/MIP3alpha(α) levels

    CCL20/MIP3alpha(α) levels in the gingival crevicular fluid (GCF)

    Baseline

Secondary Outcomes (2)

  • CCL19/MIP3beta(β) levels and clinical parameters

    Baseline

  • CCL20/MIP3alpha(α) levels and clinical parameters

    Baseline

Study Arms (3)

Stage III Grade B periodontitis group (Group 1)

Stage III Grade B periodontitis patients and systemically healthy

Diagnostic Test: Routine periodontal examination

Stage III Grade C periodontitis group (Group 2)

Stage III Grade C periodontitis patients and systemically healthy

Diagnostic Test: Routine periodontal examination

Control group (Group 3)

Periodontally healthy (control group) and systemically healthy patients

Diagnostic Test: Routine periodontal examination

Interventions

Routine periodontal examinationDIAGNOSTIC_TEST

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.

Control group (Group 3)Stage III Grade B periodontitis group (Group 1)Stage III Grade C periodontitis group (Group 2)

Eligibility Criteria

Age22 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

* Group 1: Stage III Grade B periodontitis group * Group 2: Stage III Grade C periodontitis group * Group 3: Periodontally healthy control group

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ordu University, Faculty of Dentistry

Ordu, 52100, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Periodontal Diseases

Condition Hierarchy (Ancestors)

Mouth DiseasesStomatognathic Diseases

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Target Duration
1 Year
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Professor

Study Record Dates

First Submitted

February 22, 2024

First Posted

March 4, 2024

Study Start

January 1, 2023

Primary Completion

December 1, 2023

Study Completion

December 1, 2023

Last Updated

March 8, 2024

Record last verified: 2024-03

Locations

TU(1)