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

NCT02901743 | Completed Phase 4

• 1 other identifier: D 139206060
• Study Type: interventional
• Target: 40
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Renal Insufficiency Chronic; Chronic Periodontitis

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (3)

• Clinical parameter -Gingival Index (GI)

  Change in the GI was assessed at baseline and 3 months after Scaling and rootplaning

• Clinical Parameters-Probing depth(PD) and Clinical attachment levels (CAL)

  Change in Pd was assessed at baseline and 3 months after scaling and rootplaning

• Clinical Parameter- Clinical attachment levels(CAL)

  Change in CAL was assessed at baseline and 3 months after scaling and rootplaning

Study Arms (2)

GroupI (Test)

ACTIVE COMPARATOR

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.

Other: Scaling and Root planing

Group II- (Control)

ACTIVE COMPARATOR

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.

Other: Scaling and Root planing

Interventions

Scaling and Root planing OTHER

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

Group II- (Control); GroupI (Test)

Eligibility Criteria

• Age: 35 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)
• patients diagnosed with chronic periodontitis only. (GroupII)

You may not qualify if:

• 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

Sponsors & Collaborators

• Panineeya Mahavidyalaya Institute of Dental Sciences & Research Centre: lead

Related 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.

  PMID: 19228085 BACKGROUND

• 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.

  PMID: 20500539 BACKGROUND

MeSH Terms

Conditions

Renal Insufficiency, Chronic; Chronic Periodontitis

Interventions

Tooth Exfoliation; Root Planing

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Periodontitis; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

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

Study Officials

• Rekha R Koduganti, MDS

  Panineeya Institute Of Dental Sciences and Research centre

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Post Graduate

Study Record Dates

• First Submitted: August 25, 2016
• First Posted: September 15, 2016
• Study Start: April 1, 2015
• Primary Completion: June 1, 2015
• Study Completion: July 1, 2015
• Last Updated: September 15, 2016

Record last verified: 2016-09

Data Sharing

• IPD Sharing: Will not share