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NCT Number: NCT04198610

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.

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Key information

Conditions

Gingivitis and Periodontal Diseases Gingival Diseases Gingivitis Infections Mouth Diseases Periodontal Diseases Stomatognathic Diseases

Age range

30 year–39 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Krishnadevaraya college of dental sciences

Bangalore, Karnataka, 562157, India

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Non surgical periodontal therapy

Procedure

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 outcomes

  1. estimate the change in levels of Fetuin A and MMP7 in serum at baseline and 3 months post SRP

    Time frame: Serum collection at baseline and 3 months

    Serum was collected at baseline and 3 months and subjected to ELISA

Secondary outcomes

  1. Modified Gingival index (GI)

    Time frame: At baseline and 3 months

    The index was recorded at only baseline for healthy and gingivitis groups and at baseline and 3 months post therapy for periodontitis group

  2. Relative Attachment level (RAL)

    Time frame: At baseline and 3 months

    The index was recorded at only baseline for healthy and gingivitis groups and at baseline and 3 months post therapy for periodontitis group

  3. Probing Depth (PD)

    Time frame: At baseline and 3 months

    The index was recorded at only baseline for healthy and gingivitis groups and at baseline and 3 months post therapy for periodontitis group

  4. Bleeding on Probing (BOP%)

    Time frame: At baseline and 3 months

    The index was recorded at only baseline for healthy and gingivitis groups and at baseline and 3 months post therapy for periodontitis group

  5. Plaque index (PI)

    Time frame: At baseline and 3 months

    The index was recorded at only baseline for healthy and gingivitis groups and at baseline and 3 months post therapy for periodontitis group

Sponsors and collaborators

Lead sponsor

Krishnadevaraya College of Dental Sciences & Hospital

Other

Registry information

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
Dec 13, 2019
Registry last updated
Dec 13, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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