"Effect of Scaling and Root Planing on Liver Function Test (Alanine Aminotransferase and Aspartate Aminotransferase) in Systemically Healthy - Chronic Periodontitis Subjects: a Clinical Trial."

Aim:

To evaluate effect of non- surgical periodontal therapy on liver function in systemically healthy chronic periodontitis (CP) subjects.

Materials and methods:

The study is non surgical interventional trial, includes 50 CP subjects in the age group of 35- 60 years selected from the OPD (Out Patient Department) of department of periodontology Tatyasaheb Kore Dental College and Research center (TKDC and RC), Kolhapur. CP subjects were equally divided into test group and control group. Liver function test- aspartate aminotransferase (AST), alanine aminotransferase (ALT) were checked at baseline and at 1 month after treatment. Clinical examination includes plaque index, gingival index, sulcus bleeding index, probing depth, clinical attachment loss.

Study Overview

• Status: Completed
• Conditions: Chronic Periodontitis (CP) Subjects.
• Intervention / Treatment: Procedure: Scaling and root planing

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Phase 4

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 35 years to 60 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Subjects with CP (moderate and severe) as per Centers for disease control and prevention (CDC) criteria 2007.

2. Patients without any known systemic diseases

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Exclusion Criteria:

1. Patients who have taken anti-inflammatory/antibiotic/antioxidant within 3 months of beginning of study.
2. Subjects who have undergone periodontal treatment within six months of inception of study.
3. Smokers, tobacco habits in any form and alcoholics.

4. Pregnant and lactating women.

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Study Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Scaling and Root Planing( SRP); This was an interventional study in which scaling and root planing was done in systemically healthy patients with chronic periodontitis	Procedure: Scaling and root planing; scaling and root planing as an intervention was done in patients of the test group
No Intervention: Control Group; Scaling and root planing was not done , that is no intervention is carried out in the patients of this group.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Alanine aminotransferase	1month
Aspartate aminotransferase	1 month

Secondary Outcome Measures

Outcome Measure	Time Frame
plaque index	1month
gingival index	1 month
sulcus bleeding index	1month
probing depth	1month
Clinical attachment loss	1 month

Collaborators and Investigators

• Sponsor: Tatyasaheb Kore Dental College

Study record dates

Study Major Dates

• Study Start: February 1, 2015
• Primary Completion (Actual): March 1, 2015
• Study Completion (Actual): March 1, 2015

Study Registration Dates

• First Submitted: October 17, 2015
• First Submitted That Met QC Criteria: October 21, 2015
• First Posted (Estimate): October 22, 2015

Study Record Updates

• Last Update Posted (Estimate): October 22, 2015
• Last Update Submitted That Met QC Criteria: October 21, 2015
• Last Verified: October 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Stomatognathic Diseases; Periodontal Diseases; Mouth Diseases; Periodontitis; Chronic Periodontitis
• Other Study ID Numbers: TatyasahebKoreDentalC