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Effect of Scaling and Root Planing on Serum Renal Function Markers in Chronic Periodontitis Subjects.

Primary Purpose

Chronic Periodontitis

Status
Completed
Phase
Not Applicable
Locations
India
Study Type
Interventional
Intervention
scaling and root planing
Sponsored by
Maharashtra University of Health Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Chronic Periodontitis

Eligibility Criteria

35 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Age group 35-60 years.
  2. Subjects should have at least 20 natural teeth.
  3. Subjects who have not received periodontal therapy, within preceding six months.
  4. Patients with chronic generalized periodontitis (moderate and severe) according to CDC working group, 2007 criteria.

Exclusion Criteria:

  1. Tobacco in any form and alcoholics.
  2. Any other systemic disease which can alter the course of periodontal disease.
  3. Subjects should have pregnant, women on hormone replacement therapy or hormonal contraceptives, patients taking steroidal or non-steroidal anti-inflammatory drugs (previous 3 months) or antibiotics (previous 6 months), anti-inflammatory drugs and antibiotics in the previous six month.
  4. Aggressive periodontitis.

Sites / Locations

  • Department of Periodontology

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

scaling and root planing

control group

Arm Description

this was an international study in which scaling and root planing was done in systemically healthy patients patients with chronic periodontitis

Scaling and planing was not done that no intervention is carried out in this group

Outcomes

Primary Outcome Measures

serum creatinine, serum urea, serum bilirubin
to evaluate serum renal markers at baseline and 1 month after scaling and root planing

Secondary Outcome Measures

plaque index
to evaluate plaque index at baseline and 1 month after scaling and root planing
gingival index
to evaluate gingival index at baseline and 1 month after scaling and root planing
pocket depth
to evaluate pocket depth at baseline and 1 month after scaling and root planing
clinical attachment loss
to evaluate clinical attachment loss at baseline and 1 month after scaling and root planing

Full Information

First Posted
December 3, 2015
Last Updated
December 17, 2015
Sponsor
Maharashtra University of Health Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT02636114
Brief Title
Effect of Scaling and Root Planing on Serum Renal Function Markers in Chronic Periodontitis Subjects.
Official Title
Effect of Scaling and Root Planing on Serum Renal Function Markers in Systematically Healthy Chronic Periodontitis Subjects - A Control Clinical Trial.
Study Type
Interventional

2. Study Status

Record Verification Date
December 2015
Overall Recruitment Status
Completed
Study Start Date
January 2015 (undefined)
Primary Completion Date
February 2015 (Actual)
Study Completion Date
March 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Maharashtra University of Health Sciences

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
ABSTRACT:- Introduction: Chronic periodontitis (CP), the commonest type of periodontal disease, it is an infectious disease resulting in inflammation within of the tissues supporting the teeth, progressive loss of attachment and bone loss. It is closely related to several systemic diseases, such as diabetes and cardiovascular disease. The link between periodontal disease and chronic kidney disease (CKD) may be due to infection and inflammation. The periodontal inflammatory state may increases the chronic inflammation present in CKD, thus decreasing renal function. Periodontal therapy may reduce inflammation and improves endothelial function. Aim:- To investigate the effect of mechanical non-surgical periodontal therapy on serum renal function markers in systematically healthy CP subjects. Objectives:- To evaluate the effect of scaling and root planing (SRP) on serum renal function markers such as urea, creatinine, bilurubin in systematically healthy CP patient and to compare the clinical parameters such as Gingival index (GI), Plaque index (PI), Probing depth (PD), Bleeding on probing (BOP), Clinical attachment level (CAL) between test group (TG) & control group (CG). Materials and Methods: - 51 CP patients; age ranging between 35-60 years was selected. Categorized equally into group I and groups II. Group I was test group (TG) included 25 patients and group II was control group (CG) included 26 patients. The serum levels of renal function markers included Urea, Creatinine, Bilurubin were measured. SRP was done in test group only. All the parameters were checked at baseline and one month after SRP. Comparisons of baseline and value after 1 month among each criterion among each group unpaired-t test and comparisons of two groups for each criterion by paired-t test.
Detailed Description
MATERIAL AND METHODS:- A non-surgical interventional clinical study was carried out from January 2015 to March 2015 in 51 patients at the department of Periodontology, Tatyasaheb Kore Dental College & Research Centre, New Pargaon. Prior approval for the study was obtained from the local ethical committee. Patients with chronic generalized periodontitis [(moderate and severe) according to CDC working group, 2007 criteria]. Age ranging from 35-60 ( mean 45) years, should have at least 20 natural teeth, who have not received periodontal therapy, within preceding six months were included in this study. Tobacco in any form and alcoholics, any other systemic disease which can alter the course of periodontal disease, subjects should have pregnant, women on hormone replacement therapy or hormonal contraceptives, patients taking steroidal or non-steroidal anti-inflammatory drugs (previous 3 months) or antibiotics (previous 6 months), anti-inflammatory drugs and antibiotics in the previous six month and patients with aggressive periodontitis were excluded from this study. Study was explained, including the benefits, risks and alternative treatments, the patients signed an informed consent form indicating their agreement to participate in the study and each patient was assigned a patient number in ascending order to maintain the masking of evaluators. Eg. First patient is given a number D1, Second D2, and so on. GROUPS This was a Phase 2 clinical trial with an Interventional model of parallel assignment with two arms. Hence, after screening through inclusion and exclusion criteria patients were divided into two groups, 25 (13 males and 12 females) patients were included in TG and 26 (13 males and 13 females) subjects included in CG. INTERVENTION:- The study was non-surgical controlled clinical trial. A single study co-ordinator patients into two groups by using Quick Cals, Graph pad software and it has stratified with a 1:1 allocation. SRP had performed for all subjects in TG at baseline by one trained Periodontist under local anaesthesia (if required) using Piezoelectric scaler [Satelec ACTEON P5TM], Hand scalers, Universal curette and Gracey Curette. Clinical and biochemical parameters had recorded by trained examiner in both TG and CG. BLOOD COLLECTION:- 5 ml of blood was collected from the antecubital fossa by venipuncture using 20-guage needle with 5 ml syringes. Blood samples were left to clot for (1-2) hours, then centrifuged to obtain the serum. Serum was collected in disposable plastic serum containing tube, which was stored at (2-40C) until time of assay. Estimation of levels of urea (by GLDH- urease method), bilirubin total (by Diazo Method), creatinine (modified JAFFE'S method) was done at the baseline and one month in both the groups, at ANANT laboratory, kodoli, Kolhapur (INDIA).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Periodontitis

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Non-Randomized
Enrollment
51 (Actual)

8. Arms, Groups, and Interventions

Arm Title
scaling and root planing
Arm Type
Active Comparator
Arm Description
this was an international study in which scaling and root planing was done in systemically healthy patients patients with chronic periodontitis
Arm Title
control group
Arm Type
No Intervention
Arm Description
Scaling and planing was not done that no intervention is carried out in this group
Intervention Type
Procedure
Intervention Name(s)
scaling and root planing
Other Intervention Name(s)
Non surgical periodontal therapy
Intervention Description
Scaling and root planing at baseline , checked clinical parameter and serum renal function markers at baseline and 1 month after therapy
Primary Outcome Measure Information:
Title
serum creatinine, serum urea, serum bilirubin
Description
to evaluate serum renal markers at baseline and 1 month after scaling and root planing
Time Frame
1 month
Secondary Outcome Measure Information:
Title
plaque index
Description
to evaluate plaque index at baseline and 1 month after scaling and root planing
Time Frame
1 month
Title
gingival index
Description
to evaluate gingival index at baseline and 1 month after scaling and root planing
Time Frame
1 month
Title
pocket depth
Description
to evaluate pocket depth at baseline and 1 month after scaling and root planing
Time Frame
1 month
Title
clinical attachment loss
Description
to evaluate clinical attachment loss at baseline and 1 month after scaling and root planing
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
No
Eligibility Criteria
Inclusion Criteria: Age group 35-60 years. Subjects should have at least 20 natural teeth. Subjects who have not received periodontal therapy, within preceding six months. Patients with chronic generalized periodontitis (moderate and severe) according to CDC working group, 2007 criteria. Exclusion Criteria: Tobacco in any form and alcoholics. Any other systemic disease which can alter the course of periodontal disease. Subjects should have pregnant, women on hormone replacement therapy or hormonal contraceptives, patients taking steroidal or non-steroidal anti-inflammatory drugs (previous 3 months) or antibiotics (previous 6 months), anti-inflammatory drugs and antibiotics in the previous six month. Aggressive periodontitis.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
sagar kadam, MDS
Organizational Affiliation
muhs
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Periodontology
City
Kolhapur
State/Province
Maharashtra
ZIP/Postal Code
416113
Country
India

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
renal function markers report

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Effect of Scaling and Root Planing on Serum Renal Function Markers in Chronic Periodontitis Subjects.

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