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

Chronic Periodontitis (CP) Subjects. Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02583841
• Other study ID #: TatyasahebKoreDentalC
• Status: Completed
• Phase: Phase 4
• First received: October 17, 2015
• Last updated: October 21, 2015
• Start date: February 2015
• Est. completion date: March 2015

Study information

• Verified date: October 2015
• Source: Tatyasaheb Kore Dental College
• Contact: n/a
• Is FDA regulated: No
• Health authority: India: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: March 2015
• Est. primary completion date: March 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 35 Years to 60 Years

Eligibility

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

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.

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Chronic Periodontitis
• Chronic Periodontitis (CP) Subjects.
• Periodontitis

Intervention

Procedure:
• Scaling and root planing
scaling and root planing as an intervention was done in patients of the test group

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Tatyasaheb Kore Dental College

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Alanine aminotransferase		1month	Yes
Primary	Aspartate aminotransferase		1 month	Yes
Secondary	plaque index		1month	Yes
Secondary	gingival index		1 month	Yes
Secondary	sulcus bleeding index		1month	Yes
Secondary	probing depth		1month	Yes
Secondary	Clinical attachment loss		1 month	Yes