NCT06700161

Brief Summary

Since the researchers thought that Annexin A1, Lipoxin A4 and IL-1 Beta parameters, which have been found to be related to inflammatory conditions, may increase in periodontitis, a common inflammatory gum disease, we wanted to evaluate the changes in Annexin A1, Lipoxin A4 and IL-1 Beta levels in the Gingival Crevicular Fluid of participants with periodontitis.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Mar 2024

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 16, 2024

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2024

Completed
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2024

Completed
14 days until next milestone

First Submitted

Initial submission to the registry

November 15, 2024

Completed
6 days until next milestone

First Posted

Study publicly available on registry

November 21, 2024

Completed
Last Updated

November 21, 2024

Status Verified

November 1, 2024

Enrollment Period

8 months

First QC Date

November 15, 2024

Last Update Submit

November 19, 2024

Conditions

Keywords

periodontal diseaseAnneksinlipoksin

Outcome Measures

Primary Outcomes (1)

  • Changes in Annexin and Lipoxin parameters in CGF in periodontal disease

    We expect Annexin and Lipoxin parameters to decrease and IL-1b levels to increase in periodontal disease.

    6 mounth

Study Arms (2)

Control group

Healthy group

Other: Obtaining CGF from patients

Test group

Stage III Grade C Periodontitis

Other: Obtaining CGF from patients

Interventions

Periodontal clinical parameters and Annexin and Lipoxin parameters in CGF will be compared between the test and control groups

Control groupTest group

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients applying to Kahramanmaraş Sütçü İmam University, Faculty of Dentistry, Department of Periodontics

You may qualify if:

  • The patient must be a volunteer
  • He/she must be over 18 years old
  • He/she must not have any systemic disease

You may not qualify if:

  • Smoking, drinking alcohol
  • Being pregnant or breastfeeding
  • Not volunteering
  • Having had periodontal treatment in the last 6 months
  • Having used antibiotics or anti-inflammatory drugs in the last 6 months.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kahramanmaraş Sütçü İmam University, Faculty of Dentistry, Department of Periodontics

Kahramanmaraş, Onikişubat, 46000, Turkey (Türkiye)

Location

Related Publications (4)

  • Tobon-Arroyave SI, Isaza-Guzman DM, Gomez-Ortega J, Florez-Alzate AA. Salivary levels of specialized pro-resolving lipid mediators as indicators of periodontal health/disease status. J Clin Periodontol. 2019 Oct;46(10):978-990. doi: 10.1111/jcpe.13173. Epub 2019 Aug 20.

    PMID: 31339183BACKGROUND
  • Casarin RCV, Salmon CR, Stolf CS, Paz HES, Rangel TP, Domingues RR, Pauletti BA, Paes-Leme AF, Araujo C, Santamaria MP, Ruiz KS, Monteiro MF. Salivary annexin A1: A candidate biomarker for periodontitis. J Clin Periodontol. 2023 Jul;50(7):942-951. doi: 10.1111/jcpe.13803. Epub 2023 Mar 19.

    PMID: 36935103BACKGROUND
  • Ma R, Liu Y, Xu Y, Duan D. Lipoxin A4 levels predict site-specific clinical improvements post scaling and root planing and correlate negatively with periodontal pathogens in severe periodontitis. BMC Oral Health. 2024 Feb 8;24(1):204. doi: 10.1186/s12903-024-03948-w.

    PMID: 38331747BACKGROUND
  • Schenkein HA, Papapanou PN, Genco R, Sanz M. Mechanisms underlying the association between periodontitis and atherosclerotic disease. Periodontol 2000. 2020 Jun;83(1):90-106. doi: 10.1111/prd.12304.

    PMID: 32385879BACKGROUND

Related Links

MeSH Terms

Conditions

Periodontal Diseases

Condition Hierarchy (Ancestors)

Mouth DiseasesStomatognathic Diseases

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Target Duration
60 Days
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

November 15, 2024

First Posted

November 21, 2024

Study Start

March 16, 2024

Primary Completion

October 31, 2024

Study Completion

November 1, 2024

Last Updated

November 21, 2024

Record last verified: 2024-11

Data Sharing

IPD Sharing
Will not share

ı don't want to share

Available IPD Datasets

Study Protocol (Study Protocol)Access

Locations