Clinical trial NCT05281796: Evaluation of Galectin-3 Levels in GCF And Saliva of Patients With Different Periodontal Diseases
Official title: Gingival Crevicular Fluid And Salivary Levels of Galectin-3 in Patients With Gingivitis And Patients With Stage III Periodontitis: An Observational Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Periodontal Diseases
Keywords: galectin-3
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2022-03-16
Enrollment: 66
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_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

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.

Detailed description: 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.

This study will be conducted in the Oral Medicine and Periodontology department, Faculty of Dentistry- Cairo University, Egypt.

Patients will be selected from the outpatient clinic of the department of Oral Medicine and Periodontology, Faculty of Dentistry-Cairo University.

Eligibility criteria: Inclusion Criteria:

1. 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.
2. 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.
3. For the periodontitis group that has not received periodontal treatment in the last 6 months
4. 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.
5. Presence of a minimum of 15 natural teeth.

Exclusion Criteria:

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

Primary outcomes:
measure: galectin-3 in GCF
timeFrame: 24 hours after taking the clinical measurements at the first visit
measure: galectin-3 in saliva.
timeFrame: 24 hours after taking the clinical measurements at the first visit
Secondary outcomes:
measure: Pocket depth
timeFrame: 24 hours before taking GCF and salivary samples
measure: Clinical attachment level
timeFrame: 24 hours before taking GCF and salivary samples
measure: Bleeding on Probing
timeFrame: 24 hours before taking GCF and salivary samples
measure: Plaque Index
timeFrame: 24 hours before taking GCF and salivary samples
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Cairo university Faculty of dentistry
Study officials:
affiliation: Cairo University
name: Mohamed Sa Ali, master's
role: PRINCIPAL_INVESTIGATOR
References: