Clinical trial NCT04198610: Evaluation and Correlation of Serum Fetuin-A Levels in Periodontal Health and Disease: A Clinico-biochemical Study
Official title: Evaluation and Correlation of Serum Fetuin-A Levels in Periodontal Health and Disease: A Clinico-biochemical Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Gingivitis and Periodontal Diseases
Lead sponsor: Krishnadevaraya College of Dental Sciences & Hospital
Sponsor class: OTHER
First posted: 2019-12-13
Enrollment: 60
Sex: ALL
Minimum age (years): 30
Maximum age (years): 39
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The present clinico-biochemical study was carried out to estimate the levels of Fetuin A and MMP7 in serum of systemically healthy subjects in periodontal health and disease and to evaluate the impact of periodontal interventional therapy (scaling and root planing) on the same.

Detailed description: Sixty sex-matched subjects (30 males and 30 females) belonging to a common age group (30-39 yrs) were enrolled for the study to eliminate bias from confounding factors. They were divided into three groups consisting of 20 subjects in each group based on the clinical and radiological parameters; Periodontally healthy (Group I), Chronic gingivitis (Group II) and chronic periodontitis ( Group IIIa) from whom serum samples were collected. The Group IIIb further comprised of the subjects from Group IIIa, who had received non-surgical periodontal therapy (scaling and root planing). Serum samples were collected at baseline and at 12 weeks post therapy. Fetuin A and MMP-7 concentration was determined from serum samples of patients using ELISA. The results of our study depicted that Fetuin A concentration negatively correlates, whereas, MMP7 positively correlates with the extent of periodontal inflammation. Further, Periodontal therapy demonstrated a significant increase in serum Fetuin A and decrease in MMP 7 levels establishing the influence of periodontal therapy in stabilizing their levels.

Eligibility criteria: Inclusion Criteria:

1. Age group of 30-39 years.
2. Systemically healthy subjects.
3. Patient who are co-operative and able to attend follow up.
4. Patient who have not received any periodontal treatment within the past six months of baseline examination.
5. Dentition with at least 20 functional teeth.

Exclusion Criteria:

1. Medically compromised patients (history of diabetes mellitus, liver diseases, cardiovascular disease, kidney diseases, rheumatoid arthritis, bone diseases pulmonary disease, viral and fungal infections).
2. Patients with calcification disorders (chronic kidney disease with vascular calcification, hyperparathyroidism, excessive intake of vitamin D, valvular calcific aortic stenosis
3. Aggressive periodontitis.
4. Bleeding disorders
5. Gross oral pathology and suppuration
6. Patients who had received antibiotic therapy and anti inflammatory within the last six months.
7. Anomalies of the immune system.
8. Pregnancy and lactation.

Primary outcomes:
measure: estimate the change in levels of Fetuin A and MMP7 in serum at baseline and 3 months post SRP
timeFrame: Serum collection at baseline and 3 months
Secondary outcomes:
measure: Modified Gingival index (GI)
timeFrame: At baseline and 3 months
measure: Relative Attachment level (RAL)
timeFrame: At baseline and 3 months
measure: Probing Depth (PD)
timeFrame: At baseline and 3 months
measure: Bleeding on Probing (BOP%)
timeFrame: At baseline and 3 months
measure: Plaque index (PI)
timeFrame: At baseline and 3 months
Other outcomes:
Locations:
city: Bangalore
country: India
facility: Krishnadevaraya college of dental sciences
state: Karnataka
Study officials:
affiliation: Krishnadevaraya college of Dental sciences
name: BV Karthikeyan, MDS
role: STUDY_DIRECTOR
References: