Back to results"Effect of Scaling and Root Planing on Liver Function Test (Alanine Aminotransferase and Aspartate Aminotransferase) in Systemically Healthy - Chronic Periodontitis Subjects: a Clinical Trial."
Primary Purpose
Chronic Periodontitis (CP) Subjects.
Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Scaling and root planing
Sponsored by
About this trial
This is an interventional prevention trial for Chronic Periodontitis (CP) Subjects.
Eligibility Criteria
Inclusion Criteria:
- Subjects with CP (moderate and severe) as per Centers for disease control and prevention (CDC) criteria 2007.
Patients without any known systemic diseases
-
Exclusion Criteria:
- Patients who have taken anti-inflammatory/antibiotic/antioxidant within 3 months of beginning of study.
- Subjects who have undergone periodontal treatment within six months of inception of study.
- Smokers, tobacco habits in any form and alcoholics.
Pregnant and lactating women.
-
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
No Intervention
Arm Label
Scaling and Root Planing( SRP)
Control Group
Arm Description
This was an interventional study in which scaling and root planing was done in systemically healthy patients with chronic periodontitis
Scaling and root planing was not done , that is no intervention is carried out in the patients of this group.
Outcomes
Primary Outcome Measures
Alanine aminotransferase
Aspartate aminotransferase
Secondary Outcome Measures
plaque index
gingival index
sulcus bleeding index
probing depth
Clinical attachment loss
Full Information
NCT ID
NCT02583841
First Posted
October 17, 2015
Last Updated
October 21, 2015
Sponsor
Tatyasaheb Kore Dental College
1. Study Identification
Unique Protocol Identification Number
NCT02583841
Brief Title
"Effect of Scaling and Root Planing on Liver Function Test (Alanine Aminotransferase and Aspartate Aminotransferase) in Systemically Healthy - Chronic Periodontitis Subjects: a Clinical Trial."
Study Type
Interventional
2. Study Status
Record Verification Date
October 2015
Overall Recruitment Status
Completed
Study Start Date
February 2015 (undefined)
Primary Completion Date
March 2015 (Actual)
Study Completion Date
March 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Tatyasaheb Kore Dental College
4. Oversight
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Periodontitis (CP) Subjects.
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
50 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Scaling and Root Planing( SRP)
Arm Type
Active Comparator
Arm Description
This was an interventional study in which scaling and root planing was done in systemically healthy patients with chronic periodontitis
Arm Title
Control Group
Arm Type
No Intervention
Arm Description
Scaling and root planing was not done , that is no intervention is carried out in the patients of this group.
Intervention Type
Procedure
Intervention Name(s)
Scaling and root planing
Intervention Description
scaling and root planing as an intervention was done in patients of the test group
Primary Outcome Measure Information:
Title
Alanine aminotransferase
Time Frame
1month
Title
Aspartate aminotransferase
Time Frame
1 month
Secondary Outcome Measure Information:
Title
plaque index
Time Frame
1month
Title
gingival index
Time Frame
1 month
Title
sulcus bleeding index
Time Frame
1month
Title
probing depth
Time Frame
1month
Title
Clinical attachment loss
Time Frame
1 month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
35 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Subjects with CP (moderate and severe) as per Centers for disease control and prevention (CDC) criteria 2007.
Patients without any known systemic diseases
-
Exclusion Criteria:
Patients who have taken anti-inflammatory/antibiotic/antioxidant within 3 months of beginning of study.
Subjects who have undergone periodontal treatment within six months of inception of study.
Smokers, tobacco habits in any form and alcoholics.
Pregnant and lactating women.
-
12. IPD Sharing Statement
Learn more about this trial
"Effect of Scaling and Root Planing on Liver Function Test (Alanine Aminotransferase and Aspartate Aminotransferase) in Systemically Healthy - Chronic Periodontitis Subjects: a Clinical Trial."
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