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

Chronic Periodontitis Clinical Trial

Official title:

Effect of Scaling and Root Planing on Serum Renal Function Markers in Systematically Healthy Chronic Periodontitis Subjects - A Control Clinical Trial.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02636114
• Other study ID #: MaharashtraUHS
• Status: Completed
• Phase: N/A
• First received: December 3, 2015
• Last updated: December 17, 2015
• Start date: January 2015
• Est. completion date: March 2015

Study information

• Verified date: December 2015
• Source: Maharashtra University of Health Sciences
• Contact: n/a
• Is FDA regulated: No
• Health authority: India: Indian Council of Medical Research
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 51
• Est. completion date: March 2015
• Est. primary completion date: February 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 35 Years to 60 Years

Eligibility

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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Chronic Periodontitis
• Periodontitis

Intervention

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

Locations

Country	Name	City	State
India	Department of Periodontology	Kolhapur	Maharashtra

Sponsors (1)

Lead Sponsor	Collaborator
Maharashtra University of Health Sciences

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	serum creatinine, serum urea, serum bilirubin	to evaluate serum renal markers at baseline and 1 month after scaling and root planing	1 month	Yes
Secondary	plaque index	to evaluate plaque index at baseline and 1 month after scaling and root planing	1 month	Yes
Secondary	gingival index	to evaluate gingival index at baseline and 1 month after scaling and root planing	1 month	Yes
Secondary	pocket depth	to evaluate pocket depth at baseline and 1 month after scaling and root planing	1 month	Yes
Secondary	clinical attachment loss	to evaluate clinical attachment loss at baseline and 1 month after scaling and root planing	1 month	Yes