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

NCT ID: NCT02901743

Last Updated: 2016-09-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-04-30
• Study Completion Date: 2015-07-31

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.

Conditions

Renal Insufficiency Chronic; Chronic Periodontitis

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

GroupI (Test)

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 Type: ACTIVE_COMPARATOR

Scaling and Root planing

Intervention Type: OTHER

All the patients were asked to use a preprocedural mouthrinse and scaling and rootplaning was done using ultrasonic scalers.

Group II- (Control)

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.

Group Type: ACTIVE_COMPARATOR

Scaling and Root planing

Intervention Type: OTHER

All the patients were asked to use a preprocedural mouthrinse and scaling and rootplaning was done using ultrasonic scalers.

Interventions

Scaling and Root planing

All the patients were asked to use a preprocedural mouthrinse and scaling and rootplaning was done using ultrasonic scalers.

Intervention Type: OTHER

Eligibility Criteria

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)

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

• Minimum Eligible Age: 35 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Panineeya Mahavidyalaya Institute of Dental Sciences & Research Centre

OTHER

Sponsor Role: lead

Responsible Party

Dr.Thirumalesh

Post Graduate

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Rekha R Koduganti, MDS

Role: STUDY_DIRECTOR

Panineeya Institute Of Dental Sciences and Research centre

References

Fisher MA, Taylor GW. A prediction model for chronic kidney disease includes periodontal disease. J Periodontol. 2009 Jan;80(1):16-23. doi: 10.1902/jop.2009.080226.

Reference Type: BACKGROUND

PMID: 19228085 (View on PubMed)

Graziani F, Cei S, La Ferla F, Vano M, Gabriele M, Tonetti M. Effects of non-surgical periodontal therapy on the glomerular filtration rate of the kidney: an exploratory trial. J Clin Periodontol. 2010 Jul;37(7):638-43. doi: 10.1111/j.1600-051X.2010.01578.x. Epub 2010 May 25.

Reference Type: BACKGROUND

PMID: 20500539 (View on PubMed)

Other Identifiers

D 139206060

Identifier Type: -

Identifier Source: org_study_id