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

NCT02636114 | Completed DMC

• 1 other identifier: MaharashtraUHS
• Study Type: interventional
• Target: 51
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Periodontitis

Outcome Measures

Primary Outcomes (1)

• serum creatinine, serum urea, serum bilirubin

  to evaluate serum renal markers at baseline and 1 month after scaling and root planing

  1 month

Secondary Outcomes (4)

• plaque index

  1 month

• gingival index

  1 month

• pocket depth

  1 month

• clinical attachment loss

  1 month

Study Arms (2)

scaling and root planing

ACTIVE COMPARATOR

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

control group

NO INTERVENTION

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

Interventions

scaling and root planing PROCEDURE

Scaling and root planing at baseline , checked clinical parameter and serum renal function markers at baseline and 1 month after therapy

Also known as: Non surgical periodontal therapy

scaling and root planing

Eligibility Criteria

• Age: 35 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Maharashtra University of Health Sciences: lead

Study Sites (1)

Department of Periodontology

Kolhāpur, Maharashtra, 416113, India

Location

MeSH Terms

Conditions

Chronic Periodontitis

Interventions

Tooth Exfoliation; Root Planing

Condition Hierarchy (Ancestors)

Periodontitis; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Dental Physiological Phenomena; Digestive System and Oral Physiological Phenomena; Dental Scaling; Dental Prophylaxis; Periodontics; Dentistry; Subgingival Curettage; Preventive Dentistry

Study Officials

• sagar kadam, MDS

  muhs

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Post graduate student

Study Record Dates

• First Submitted: December 3, 2015
• First Posted: December 21, 2015
• Study Start: January 1, 2015
• Primary Completion: February 1, 2015
• Study Completion: March 1, 2015
• Last Updated: December 21, 2015

Record last verified: 2015-12

Data Sharing

• IPD Sharing: Will share

Locations

IN (1)