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

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.

Study Overview

• Status: Completed
• Conditions: Gingivitis and Periodontal Diseases
• Intervention / Treatment: Procedure: Non surgical periodontal therapy

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.

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• India
  • Karnataka
    • Bangalore, Karnataka, India, 562157
      • Krishnadevaraya college of dental sciences

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 39 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
NO_INTERVENTION: healthy; Ten patients with clinically healthy gingiva with probing depth less than 3mm and less than or equal to 10% sites with gingival bleeding on probing present.
NO_INTERVENTION: chronic gingivitis; Chronic gingivitis was defined as having probing depth (PD) less than or equal to 4mm, relative attachment loss (RAL) ) less than or equal to 3mm and more than to 25% sites with gingival bleeding present (BOP)
ACTIVE_COMPARATOR: chronic periodontitis; Chronic periodontitis was defined as having probing depth more than or equal to 5mm, RAL more than or equal to 8mm, with more than or equal to 10% sites with BOP positive and evidence of bone loss determined radiographically. Non surgical periodontal therapy (SRP) was concluded in 3 months. Within the duration of the study, all subjects received supportive therapy	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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

Collaborators and Investigators

• Sponsor: Krishnadevaraya College of Dental Sciences & Hospital
• Investigators: Study Director: BV Karthikeyan, MDS, Krishnadevaraya college of dental sciences

Study record dates

Study Major Dates

• Study Start (ACTUAL): March 10, 2017
• Primary Completion (ACTUAL): August 28, 2017
• Study Completion (ACTUAL): August 28, 2017

Study Registration Dates

• First Submitted: February 26, 2019
• First Submitted That Met QC Criteria: December 11, 2019
• First Posted (ACTUAL): December 13, 2019

Study Record Updates

• Last Update Posted (ACTUAL): December 13, 2019
• Last Update Submitted That Met QC Criteria: December 11, 2019
• Last Verified: February 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infections; Stomatognathic Diseases; Mouth Diseases; Gingival Diseases; Gingivitis; Periodontal Diseases
• Other Study ID Numbers: 02_D012_63396

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No