Effect on Teeth and Gum Cleaning in Patients With Gum and Kidney Disease

Phase 4

Completed

• Conditions: Chronic Periodontitis; Renal Insufficiency Chronic
• Interventions: Other: Scaling and Root planing

• Registration Number: NCT02901743
• Lead Sponsor: Panineeya Mahavidyalaya Institute of Dental Sciences & Research Centre

Brief Summary

The main aim and objective of this study was to evaluate the effects of Non- surgical periodontal therapy on the subgingival microbiota and biochemical parameters in patients with chronic kidney disease and chronic periodontitis.

Detailed Description

The study was designed as a Non randomized prospective, interventional clinical trial. The sample size for the study was 40 individuals aged between 35-75 years, equally divided into two groups.

Group I--- Patients with Chronic kidney disease and chronic periodontitis (Test) Group II--- Patients with Chronic periodontitis only (Controls) At baseline both the groups were analyzed for clinical, microbiological and also biochemical parameters and underwent Non-surgical Periodontal treatment (i.e. scaling and root planning). All parameters were reassessed again after 3 months.

A total of 20 patients attending the outpatient wing of Hyderabad Kidney Centre , Malakpet,Hyderabad who were diagnosed clinically with Chronic Kidney disease and willing to participate in the study were included in the study.

Another 20 patients attending the outpatient wing of Department of periodontics, Panineeya Mahavidyalaya Institute of Dental Sciences \& Hospital, Hyderabad, diagnosed with Chronic Periodontitis and willing to participate in the study were taken.

Biochemical parameters considered included -serum creatin \& urinary albumin: creatin ratio.

Microbiological assay was done by Polymerase chain reaction test (PCR) i.e., pooled plaque samples were taken from both predialysis as well as chronic periodontitis patients.

Study Timeline

• Study Start: 2015-04
• Primary Completion: 2015-06
• Study Completion: 2015-07
• Study First Submitted: 2016-08-25
• Status Verified: 2016-09
• Study First Submitted QC: 2016-09-09
• Last Update Submitted: 2016-09-09
• Study First Posted: 2016-09-15
• Last Update Posted: 2016-09-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• A total of 20 patients diagnosed with Chronic kidney disease, (having abnormal Glomerular filtration rate(GFR) and serum Creatinine levels.) and chronic periodontitis (with at least 15 teeth remaining, and with the presence of ≥4 sites in 3 different teeth having clinical attachment loss (CAL) of ≥ 4mm and bleeding on probing). (Group I)
• 20 patients diagnosed with chronic periodontitis only. (GroupII)

Read More

Exclusion Criteria

• Patients with HIV infection, pregnancy, lupus erythematosus, rheumatoid arthritis, any systemic disorder, periodontal therapy in the preceding 6 months, or on any course of antibiotic prophylaxis for periodontal procedures were excluded from the study

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
GroupI (Test)	Scaling and Root planing	20 patients with renal insufficiency chronic and chronic periodontitis underwent scaling and root planing. Clinical parameters( GI,PD,CAL) were assessed at baseline and after 3 months. 2ml blood was drawn to assess serum creatinine levels and urine analysis was done at baseline and after 3 months for urinary albumin: creatinine ratio.Pooled plaque samples were taken at baseline and after 3 months to assess the microbial activity of Treponema Denticola and Tannerella Forsythia by PCR.
Group II- (Control)	Scaling and Root planing	20 patients with chronic periodontitis who underwent scaling and root planing.Clinical parameters(GI,PD,CAL)were assessed at baseline and after 3 months. 2ml blood was drawn to assess seum creatnine levels and urine analysis was done at baseline and after 3 months for serum urinary Albumin:Creatinine ratio.Pooled plaque samples were taken at baseline and after 3 months to assess the microbial activity of Treponema denticola and Tannerella Forsythia by PCR.

Primary Outcome Measures

Name	Time	Method
Levels of Microbiological and Biochemical Parameters	Change in levels of Microbiological and Biochemical parameters were assessed at baseline and 3 months after scaling and rootplaning	Microbiological assay was done by PCR test i.e., pooled plaque samples were taken from both predialysis as well as chronic periodontitis patients at baseline and 3 months after scaling and root planing.; Supragingival plaque was removed carefully with a sterile scaler to prevent the contamination of the samples.Sample was harvested from the same site with a sterile Gracey curet 5-6 with one single vertical stroke on the root surface.; Biochemical assay was done by Modified Jaffe's reaction to assess the levels of Serum Creatinine and urine samples were taken to assess the Albumin:Creatinine ratio

Secondary Outcome Measures

Name	Time	Method
Clinical parameter -Gingival Index (GI)	Change in the GI was assessed at baseline and 3 months after Scaling and rootplaning	The Gingival index was assessed using a University of Carolina-15 (UNC-15) Probe.
Clinical Parameters-Probing depth(PD) and Clinical attachment levels (CAL)	Change in Pd was assessed at baseline and 3 months after scaling and rootplaning	The Pd was assessed using UNC-15 Probe
Clinical Parameter- Clinical attachment levels(CAL)	Change in CAL was assessed at baseline and 3 months after scaling and rootplaning	The CAL was assessed using UNC-15 Probe