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

Chronic Periodontitis Clinical Trial

— ETGPGK  

Official title:

"Efficacy of Nonsurgical Periodontal Therapy in Patients With Chronic Renal Disease and Periodontitis: A Biochemical and Microbiological Assay"

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02901743
• Other study ID #: D 139206060
• Status: Completed
• Phase: Phase 4
• First received: August 25, 2016
• Last updated: September 9, 2016
• Start date: April 2015
• Est. completion date: July 2015

Study information

• Verified date: September 2016
• Source: Panineeya Mahavidyalaya Institute of Dental Sciences & Research Centre
• Contact: n/a
• Is FDA regulated: No
• Health authority: India: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: July 2015
• Est. primary completion date: June 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 35 Years to 75 Years

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Periodontitis
• Periodontitis
• Renal Insufficiency
• Renal Insufficiency Chronic

Intervention

Other:
• Scaling and Root planing
All the patients were asked to use a preprocedural mouthrinse and scaling and rootplaning was done using ultrasonic scalers.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Panineeya Mahavidyalaya Institute of Dental Sciences & Research Centre

References & Publications (2)

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 . — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Levels of Microbiological and Biochemical Parameters	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	Change in levels of Microbiological and Biochemical parameters were assessed at baseline and 3 months after scaling and rootplaning	No
Secondary	Clinical parameter -Gingival Index (GI)	The Gingival index was assessed using a University of Carolina-15 (UNC-15) Probe.	Change in the GI was assessed at baseline and 3 months after Scaling and rootplaning	No
Secondary	Clinical Parameters-Probing depth(PD) and Clinical attachment levels (CAL)	The Pd was assessed using UNC-15 Probe	Change in Pd was assessed at baseline and 3 months after scaling and rootplaning	No
Secondary	Clinical Parameter- Clinical attachment levels(CAL)	The CAL was assessed using UNC-15 Probe	Change in CAL was assessed at baseline and 3 months after scaling and rootplaning	No