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

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ClinicalTrials.gov Identifier: NCT02901743
Recruitment Status : Completed
First Posted : September 15, 2016
Last Update Posted : September 15, 2016
Sponsor:
Information provided by (Responsible Party):
Dr.Thirumalesh, 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.

Condition or disease Intervention/treatment Phase
Renal Insufficiency Chronic Chronic Periodontitis Other: Scaling and Root planing Phase 4

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: "Efficacy of Nonsurgical Periodontal Therapy in Patients With Chronic Renal Disease and Periodontitis: A Biochemical and Microbiological Assay"
Study Start Date : April 2015
Actual Primary Completion Date : June 2015
Actual Study Completion Date : July 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Kidney Diseases

Arm Intervention/treatment
Active Comparator: 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.
Other: Scaling and Root planing
All the patients were asked to use a preprocedural mouthrinse and scaling and rootplaning was done using ultrasonic scalers.

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




Primary Outcome Measures :
  1. Levels of Microbiological and Biochemical Parameters [ Time Frame: 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 :
  1. Clinical parameter -Gingival Index (GI) [ Time Frame: 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.

  2. Clinical Parameters-Probing depth(PD) and Clinical attachment levels (CAL) [ Time Frame: Change in Pd was assessed at baseline and 3 months after scaling and rootplaning ]
    The Pd was assessed using UNC-15 Probe

  3. Clinical Parameter- Clinical attachment levels(CAL) [ Time Frame: Change in CAL was assessed at baseline and 3 months after scaling and rootplaning ]
    The CAL was assessed using UNC-15 Probe



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Ages Eligible for Study:   35 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02901743


Sponsors and Collaborators
Panineeya Mahavidyalaya Institute of Dental Sciences & Research Centre
Investigators
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Study Director: Rekha R Koduganti, MDS Panineeya Institute Of Dental Sciences and Research centre

Publications:
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Responsible Party: Dr.Thirumalesh, Post Graduate, Panineeya Mahavidyalaya Institute of Dental Sciences & Research Centre
ClinicalTrials.gov Identifier: NCT02901743     History of Changes
Other Study ID Numbers: D 139206060
First Posted: September 15, 2016    Key Record Dates
Last Update Posted: September 15, 2016
Last Verified: September 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Periodontitis
Chronic Periodontitis
Renal Insufficiency
Periodontal Diseases
Mouth Diseases
Stomatognathic Diseases
Kidney Diseases
Urologic Diseases