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Effect on Teeth and Gum Cleaning in Patients With Gum and Kidney Disease (ETGPGK)

Primary Purpose

Renal Insufficiency Chronic, Chronic Periodontitis

Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Scaling and Root planing
Sponsored by
Panineeya Mahavidyalaya Institute of Dental Sciences & Research Centre
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Renal Insufficiency Chronic

Eligibility Criteria

35 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Active Comparator

    Arm Label

    GroupI (Test)

    Group II- (Control)

    Arm Description

    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.

    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.

    Outcomes

    Primary Outcome Measures

    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

    Secondary Outcome Measures

    Clinical parameter -Gingival Index (GI)
    The Gingival index was assessed using a University of Carolina-15 (UNC-15) Probe.
    Clinical Parameters-Probing depth(PD) and Clinical attachment levels (CAL)
    The Pd was assessed using UNC-15 Probe
    Clinical Parameter- Clinical attachment levels(CAL)
    The CAL was assessed using UNC-15 Probe

    Full Information

    First Posted
    August 25, 2016
    Last Updated
    September 9, 2016
    Sponsor
    Panineeya Mahavidyalaya Institute of Dental Sciences & Research Centre
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02901743
    Brief Title
    Effect on Teeth and Gum Cleaning in Patients With Gum and Kidney Disease
    Acronym
    ETGPGK
    Official Title
    "Efficacy of Nonsurgical Periodontal Therapy in Patients With Chronic Renal Disease and Periodontitis: A Biochemical and Microbiological Assay"
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2016
    Overall Recruitment Status
    Completed
    Study Start Date
    April 2015 (undefined)
    Primary Completion Date
    June 2015 (Actual)
    Study Completion Date
    July 2015 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Panineeya Mahavidyalaya Institute of Dental Sciences & Research Centre

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Renal Insufficiency Chronic, Chronic Periodontitis

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 4
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Non-Randomized
    Enrollment
    40 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    GroupI (Test)
    Arm Type
    Active Comparator
    Arm Description
    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.
    Arm Title
    Group II- (Control)
    Arm Type
    Active Comparator
    Arm Description
    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.
    Intervention Type
    Other
    Intervention Name(s)
    Scaling and Root planing
    Intervention Description
    All the patients were asked to use a preprocedural mouthrinse and scaling and rootplaning was done using ultrasonic scalers.
    Primary Outcome Measure Information:
    Title
    Levels of Microbiological and Biochemical Parameters
    Description
    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
    Time Frame
    Change in levels of Microbiological and Biochemical parameters were assessed at baseline and 3 months after scaling and rootplaning
    Secondary Outcome Measure Information:
    Title
    Clinical parameter -Gingival Index (GI)
    Description
    The Gingival index was assessed using a University of Carolina-15 (UNC-15) Probe.
    Time Frame
    Change in the GI was assessed at baseline and 3 months after Scaling and rootplaning
    Title
    Clinical Parameters-Probing depth(PD) and Clinical attachment levels (CAL)
    Description
    The Pd was assessed using UNC-15 Probe
    Time Frame
    Change in Pd was assessed at baseline and 3 months after scaling and rootplaning
    Title
    Clinical Parameter- Clinical attachment levels(CAL)
    Description
    The CAL was assessed using UNC-15 Probe
    Time Frame
    Change in CAL was assessed at baseline and 3 months after scaling and rootplaning

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    35 Years
    Maximum Age & Unit of Time
    75 Years
    Accepts Healthy Volunteers
    No
    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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Rekha R Koduganti, MDS
    Organizational Affiliation
    Panineeya Institute Of Dental Sciences and Research centre
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    19228085
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    20500539
    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.
    Results Reference
    background

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

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