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

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ClinicalTrials.gov Identifier: NCT02636114
Recruitment Status : Completed
First Posted : December 21, 2015
Last Update Posted : December 21, 2015
Sponsor:
Information provided by (Responsible Party):
Sagar Kadam, Maharashtra University of Health Sciences

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.


Condition or disease Intervention/treatment Phase
Chronic Periodontitis Procedure: scaling and root planing Not Applicable

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).


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 51 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Prevention
Official Title: Effect of Scaling and Root Planing on Serum Renal Function Markers in Systematically Healthy Chronic Periodontitis Subjects - A Control Clinical Trial.
Study Start Date : January 2015
Actual Primary Completion Date : February 2015
Actual Study Completion Date : March 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Kidney Tests

Arm Intervention/treatment
Active Comparator: scaling and root planing
this was an international study in which scaling and root planing was done in systemically healthy patients patients with chronic periodontitis
Procedure: scaling and root planing
Scaling and root planing at baseline , checked clinical parameter and serum renal function markers at baseline and 1 month after therapy
Other Name: Non surgical periodontal therapy

No Intervention: control group
Scaling and planing was not done that no intervention is carried out in this group



Primary Outcome Measures :
  1. serum creatinine, serum urea, serum bilirubin [ Time Frame: 1 month ]
    to evaluate serum renal markers at baseline and 1 month after scaling and root planing


Secondary Outcome Measures :
  1. plaque index [ Time Frame: 1 month ]
    to evaluate plaque index at baseline and 1 month after scaling and root planing

  2. gingival index [ Time Frame: 1 month ]
    to evaluate gingival index at baseline and 1 month after scaling and root planing

  3. pocket depth [ Time Frame: 1 month ]
    to evaluate pocket depth at baseline and 1 month after scaling and root planing

  4. clinical attachment loss [ Time Frame: 1 month ]
    to evaluate clinical attachment loss at baseline and 1 month after scaling and root planing



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Ages Eligible for Study:   35 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02636114


Locations
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India
Department of Periodontology
Kolhapur, Maharashtra, India, 416113
Sponsors and Collaborators
Maharashtra University of Health Sciences
Investigators
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Principal Investigator: sagar kadam, MDS muhs

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Responsible Party: Sagar Kadam, Post graduate student, Maharashtra University of Health Sciences
ClinicalTrials.gov Identifier: NCT02636114     History of Changes
Other Study ID Numbers: MaharashtraUHS
First Posted: December 21, 2015    Key Record Dates
Last Update Posted: December 21, 2015
Last Verified: December 2015
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: renal function markers report

Additional relevant MeSH terms:
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Periodontitis
Chronic Periodontitis
Periodontal Diseases
Mouth Diseases
Stomatognathic Diseases