Evaluation and Correlation of Serum Fetuin-A Levels in Periodontal Health and Disease: A Clinico-biochemical Study

Gingivitis and Periodontal Diseases Clinical Trial

Official title:

Evaluation and Correlation of Serum Fetuin-A Levels in Periodontal Health and Disease: A Clinico-biochemical Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04198610
• Other study ID #: 02_D012_63396
• Status: Completed
• Phase: N/A
• Start date: March 10, 2017
• Est. completion date: August 28, 2017

Study information

• Verified date: February 2019
• Source: Krishnadevaraya College of Dental Sciences & Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: August 28, 2017
• Est. primary completion date: August 28, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 30 Years to 39 Years

Eligibility

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.

Related Conditions & MeSH terms

• Gingivitis
• Gingivitis and Periodontal Diseases
• Periodontal Diseases

Intervention

Procedure:
• Non surgical periodontal therapy
Procedure/Surgery: non surgical periodontal therapy and root planing (SRP) was performed in two to four appointments lasting approximately 60 minutes each under local anaesthesia (2% lignocaine hydrochloride with 1:2,00,000 adrenaline) using area specific Gracey periodontal curettes and an ultrasonic device. The treatment was concluded in 3 months. Within the duration of the study, all subjects received supportive therapy, which included professional plaque control and reinstruction of oral hygiene.

Locations

Country	Name	City	State
India	Krishnadevaraya college of dental sciences	Bangalore	Karnataka

Sponsors (1)

Lead Sponsor	Collaborator
Krishnadevaraya College of Dental Sciences & Hospital

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	estimate the change in levels of Fetuin A and MMP7 in serum at baseline and 3 months post SRP	Serum was collected at baseline and 3 months and subjected to ELISA	Serum collection at baseline and 3 months
Secondary	Modified Gingival index (GI)	The index was recorded at only baseline for healthy and gingivitis groups and at baseline and 3 months post therapy for periodontitis group	At baseline and 3 months
Secondary	Relative Attachment level (RAL)	The index was recorded at only baseline for healthy and gingivitis groups and at baseline and 3 months post therapy for periodontitis group	At baseline and 3 months
Secondary	Probing Depth (PD)	The index was recorded at only baseline for healthy and gingivitis groups and at baseline and 3 months post therapy for periodontitis group	At baseline and 3 months
Secondary	Bleeding on Probing (BOP%)	The index was recorded at only baseline for healthy and gingivitis groups and at baseline and 3 months post therapy for periodontitis group	At baseline and 3 months
Secondary	Plaque index (PI)	The index was recorded at only baseline for healthy and gingivitis groups and at baseline and 3 months post therapy for periodontitis group	At baseline and 3 months