Clinical trial NCT02901743: Effect on Teeth and Gum Cleaning in Patients With Gum and Kidney Disease
Official title: "Efficacy of Nonsurgical Periodontal Therapy in Patients With Chronic Renal Disease and Periodontitis: A Biochemical and Microbiological Assay"
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Renal Insufficiency Chronic
Chronic Periodontitis
Lead sponsor: Panineeya Mahavidyalaya Institute of Dental Sciences & Research Centre
Sponsor class: OTHER
First posted: 2016-09-15
Enrollment: 40
Sex: ALL
Minimum age (years): 35
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Levels of Microbiological and Biochemical Parameters
timeFrame: Change in levels of Microbiological and Biochemical parameters were assessed at baseline and 3 months after scaling and rootplaning
Secondary outcomes:
measure: Clinical parameter -Gingival Index (GI)
timeFrame: Change in the GI was assessed at baseline and 3 months after Scaling and rootplaning
measure: Clinical Parameters-Probing depth(PD) and Clinical attachment levels (CAL)
timeFrame: Change in Pd was assessed at baseline and 3 months after scaling and rootplaning
measure: Clinical Parameter- Clinical attachment levels(CAL)
timeFrame: Change in CAL was assessed at baseline and 3 months after scaling and rootplaning
Other outcomes:
Locations:
Study officials:
affiliation: Panineeya Institute Of Dental Sciences and Research centre
name: Rekha R Koduganti, MDS
role: STUDY_DIRECTOR
References:
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.
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.