Clinical trial NCT02636114: 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
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Periodontitis
Lead sponsor: Maharashtra University of Health Sciences
Sponsor class: OTHER
First posted: 2015-12-21
Enrollment: 51
Sex: ALL
Minimum age (years): 35
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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).

Eligibility 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.

Primary outcomes:
measure: serum creatinine, serum urea, serum bilirubin
timeFrame: 1 month
Secondary outcomes:
measure: plaque index
timeFrame: 1 month
measure: gingival index
timeFrame: 1 month
measure: pocket depth
timeFrame: 1 month
measure: clinical attachment loss
timeFrame: 1 month
Other outcomes:
Locations:
city: Kolhapur
country: India
facility: Department of Periodontology
state: Maharashtra
Study officials:
affiliation: muhs
name: sagar kadam, MDS
role: PRINCIPAL_INVESTIGATOR
References: