NCT05281796

Brief Summary

The aim of this study is to assess the levels of galectin-3 in the GCF and saliva in patient with gingivitis and patient with stage III periodontitis.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
66

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2022

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

January 22, 2022

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

March 7, 2022

Completed
9 days until next milestone

First Posted

Study publicly available on registry

March 16, 2022

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 15, 2023

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 15, 2023

Completed
Last Updated

November 24, 2023

Status Verified

November 1, 2023

Enrollment Period

1.4 years

First QC Date

March 7, 2022

Last Update Submit

November 22, 2023

Conditions

Periodontal Diseases

Keywords

galectin-3

Outcome Measures

Primary Outcomes (2)

  • galectin-3 in GCF

    The total amount of Galectin-3 in GCF

    24 hours after taking the clinical measurements at the first visit

  • galectin-3 in saliva.

    The total amount of Galectin-3 in saliva

    24 hours after taking the clinical measurements at the first visit

Secondary Outcomes (4)

  • Pocket depth

    24 hours before taking GCF and salivary samples

  • Clinical attachment level

    24 hours before taking GCF and salivary samples

  • Bleeding on Probing

    24 hours before taking GCF and salivary samples

  • Plaque Index

    24 hours before taking GCF and salivary samples

Study Arms (3)

healthy patient

Full-mouth clinical periodontal measurements recorded, saliva and GCF obtained

Diagnostic Test: GCF obtainingDiagnostic Test: saliva obtaining

gingivitis patient

Full-mouth clinical periodontal measurements recorded, saliva and GCF obtained

Diagnostic Test: GCF obtainingDiagnostic Test: saliva obtaining

patients with Stage III periodontitis

Full-mouth clinical periodontal measurements recorded, saliva and GCF obtained

Diagnostic Test: GCF obtainingDiagnostic Test: saliva obtaining

Interventions

GCF obtainingDIAGNOSTIC_TEST

GCF sample collection by Enzyme-Linked Immunosorbent Assay (ELISA)

gingivitis patienthealthy patientpatients with Stage III periodontitis
saliva obtainingDIAGNOSTIC_TEST

Saliva sample collection by Enzyme-Linked Immunosorbent Assay (ELISA)

gingivitis patienthealthy patientpatients with Stage III periodontitis

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Dental patients will be recruited in a consecutive manner from the clinic of the department of Oral Medicine and Periodontology, Faculty of Dentistry - Cairo University. Medical history and dental history will be taken; thorough oral examination will be done. The aim of the study will be explained to the patient and the patient's acceptance to participate in the survey will be received. Nonrespondent patients or patients refusing to participate will be reported with the cause of their refusal. Conventional oral and periodontal examination will be held on a dental unit using the light of the unit, mirror and probe

You may qualify if:

  • For healthy group: individuals with less than 10% bleeding on probing area, having a probing depth less than 4mm and no loss of attachment were included in the study.
  • For the gingivitis group: individuals with 10% or more bleeding on probing area, having a probing depth of less than 4mm and no attachment loss.
  • For the periodontitis group that has not received periodontal treatment in the last 6 months
  • For the periodontitis group: individuals with 30% or more bleeding on probing area, at least 2 teeth not adjacent to each quarter jaw with a depth of 5 mm or more and 4 mm or more attachment loss, coronal 1/3 and more on radiography (horizontal and / or vertical) bone loss.
  • Presence of a minimum of 15 natural teeth.

You may not qualify if:

  • Individuals with any known systemic disease.
  • Pregnant and lactating women.
  • Individuals that received periodontal treatment within the last 6 months.
  • Individuals with a history of systemic antibiotics and anti-inflammatory drugs within the last 3 months.
  • Former or current smokers.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cairo university Faculty of dentistry

Cairo, 11311, Egypt

Location

MeSH Terms

Conditions

Periodontal Diseases

Condition Hierarchy (Ancestors)

Mouth DiseasesStomatognathic Diseases

Study Officials

  • Mohamed Sa Ali, master's

    Cairo University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator mohamed saad

Study Record Dates

First Submitted

March 7, 2022

First Posted

March 16, 2022

Study Start

January 22, 2022

Primary Completion

June 15, 2023

Study Completion

August 15, 2023

Last Updated

November 24, 2023

Record last verified: 2023-11

Locations

EG(1)