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

Primary Purpose

Gingivitis and Periodontal Diseases

Status
Completed
Phase
Not Applicable
Locations
India
Study Type
Interventional
Intervention
Non surgical periodontal therapy
Sponsored by
Krishnadevaraya College of Dental Sciences & Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Gingivitis and Periodontal Diseases

Eligibility Criteria

30 Years - 39 Years (Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Krishnadevaraya college of dental sciences

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

No Intervention

No Intervention

Active Comparator

Arm Label

healthy

chronic gingivitis

chronic periodontitis

Arm Description

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.

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)

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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
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
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
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
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

Full Information

First Posted
February 26, 2019
Last Updated
December 11, 2019
Sponsor
Krishnadevaraya College of Dental Sciences & Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04198610
Brief Title
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

2. Study Status

Record Verification Date
February 2019
Overall Recruitment Status
Completed
Study Start Date
March 10, 2017 (Actual)
Primary Completion Date
August 28, 2017 (Actual)
Study Completion Date
August 28, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Krishnadevaraya College of Dental Sciences & Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gingivitis and Periodontal Diseases

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
healthy
Arm Type
No Intervention
Arm Description
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.
Arm Title
chronic gingivitis
Arm Type
No Intervention
Arm Description
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)
Arm Title
chronic periodontitis
Arm Type
Active Comparator
Arm Description
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
Intervention Type
Procedure
Intervention Name(s)
Non surgical periodontal therapy
Intervention Description
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.
Primary Outcome Measure Information:
Title
estimate the change in levels of Fetuin A and MMP7 in serum at baseline and 3 months post SRP
Description
Serum was collected at baseline and 3 months and subjected to ELISA
Time Frame
Serum collection at baseline and 3 months
Secondary Outcome Measure Information:
Title
Modified Gingival index (GI)
Description
The index was recorded at only baseline for healthy and gingivitis groups and at baseline and 3 months post therapy for periodontitis group
Time Frame
At baseline and 3 months
Title
Relative Attachment level (RAL)
Description
The index was recorded at only baseline for healthy and gingivitis groups and at baseline and 3 months post therapy for periodontitis group
Time Frame
At baseline and 3 months
Title
Probing Depth (PD)
Description
The index was recorded at only baseline for healthy and gingivitis groups and at baseline and 3 months post therapy for periodontitis group
Time Frame
At baseline and 3 months
Title
Bleeding on Probing (BOP%)
Description
The index was recorded at only baseline for healthy and gingivitis groups and at baseline and 3 months post therapy for periodontitis group
Time Frame
At baseline and 3 months
Title
Plaque index (PI)
Description
The index was recorded at only baseline for healthy and gingivitis groups and at baseline and 3 months post therapy for periodontitis group
Time Frame
At baseline and 3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
39 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Age group of 30-39 years. Systemically healthy subjects. Patient who are co-operative and able to attend follow up. Patient who have not received any periodontal treatment within the past six months of baseline examination. Dentition with at least 20 functional teeth. Exclusion Criteria: Medically compromised patients (history of diabetes mellitus, liver diseases, cardiovascular disease, kidney diseases, rheumatoid arthritis, bone diseases pulmonary disease, viral and fungal infections). Patients with calcification disorders (chronic kidney disease with vascular calcification, hyperparathyroidism, excessive intake of vitamin D, valvular calcific aortic stenosis Aggressive periodontitis. Bleeding disorders Gross oral pathology and suppuration Patients who had received antibiotic therapy and anti inflammatory within the last six months. Anomalies of the immune system. Pregnancy and lactation.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
BV Karthikeyan, MDS
Organizational Affiliation
Krishnadevaraya college of Dental sciences
Official's Role
Study Director
Facility Information:
Facility Name
Krishnadevaraya college of dental sciences
City
Bangalore
State/Province
Karnataka
ZIP/Postal Code
562157
Country
India

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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

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