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

NCT04198610 | Completed

• 1 other identifier: 02_D012_63396
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Gingivitis and Periodontal Diseases

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Modified Gingival index (GI)

  At baseline and 3 months

• Relative Attachment level (RAL)

  At baseline and 3 months

• Probing Depth (PD)

  At baseline and 3 months

• Bleeding on Probing (BOP%)

  At baseline and 3 months

• Plaque index (PI)

  At baseline and 3 months

Study Arms (3)

healthy

NO INTERVENTION

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

NO INTERVENTION

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

ACTIVE COMPARATOR

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

Interventions

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.

chronic periodontitis

Eligibility Criteria

• Age: 30 Years - 39 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Krishnadevaraya College of Dental Sciences & Hospital: lead

Study Sites (1)

Krishnadevaraya college of dental sciences

Bangalore, Karnataka, 562157, India

Location

MeSH Terms

Conditions

Gingivitis; Periodontal Diseases

Condition Hierarchy (Ancestors)

Infections; Gingival Diseases; Mouth Diseases; Stomatognathic Diseases

Study Officials

• BV Karthikeyan, MDS

  Krishnadevaraya college of Dental sciences

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 26, 2019
• First Posted: December 13, 2019
• Study Start: March 10, 2017
• Primary Completion: August 28, 2017
• Study Completion: August 28, 2017
• Last Updated: December 13, 2019

Record last verified: 2019-02

Locations

IN (1)