Association of Apical Periodontitis With Chronic Kidney Disease

Prevalence of of Apical Periodontal in Patients Chronic Kidney Disease & Its Association With Markers of Kidney Disease.

This investigation is aimed to assess the prevalence and severity of apical periodontitis (AP) in different stages of CKD patients and its impact on the systemic (nutritional and inflammatory) markers was compared to healthy individuals.

Study Overview

• Status: Completed
• Conditions: Chronic Kidney Diseases; Periapical Lesions
• Intervention / Treatment: Biological: levels of CKD markers, Oral health status, apical periodontitis; Biological: systemic inflammatory marker, Oral health status, apical periodontitis

Detailed Description

105 CKD patients (35 early (EG), 35pre-dialysis (PDG) and 35 hemodialysis (HDG)groups and 105 age and gender matched healthy controls were assessed for prevalence and severity of apical periodontitis and oral disease burden . Inflammatory (hsCRP and ferritin) and nutritional (urea and creatinine) markers were estimated and eGFR was calculated for the study population. Logistic regression was used to determine the possible association between CKD and AP in study population and Linear regression was performed to evaluate the possible association between systemic markers and endodontic burden (EB) in experimental group.

• Study Type: Observational
• Enrollment (Actual): 210

Contacts and Locations

Study Locations

• India
  • Haryana
    • Rohtak, Haryana, India, 124001
      • PGIDS

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

CKD patients of different levels (Stage 1 to Stage 5) with age and gender matched controls will be enrolled in the study.

Description

Inclusion Criteria:

• Known patient of CKD Stages 1,2,3,4 & 5 with estimated glomerular filtration rate [eGFR; MDRD] with mature permanent teeth.
• > 18 years
• > 8 natural teeth.
• Complete medical & dental history including panoramic radiographs of maxilla & mandible

Exclusion Criteria:

• Patients having systemic disorders other than CKD (eg HIV, Diabetes mellitus, Coronary heart disease, history of secondary hyperparathyroidism).
• Pregnancy, lactation & contraceptives.
• Systemic conditions that contra indicates dental treatment.
• Use of antibiotics & anti-inflammatory in last 3 months
• Need for antibiotic prophylaxis.
• Hepatitis C and B virus.
• Patients on steroids.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Group-A CKD patients; Prevalence of apical periodontitis will be checked and non-surgical root canal treatment will be given to the patients with apical periodontitis and change in PAI score, eGFR & Systemic markers will be checked	Biological: levels of CKD markers, Oral health status, apical periodontitis; To observe levels of CKD markers :Levels of serum keratinise ,urea, eGFR, and assessment of Oral health status, apical periodontitis
Group-B Healthy individuals; Prevalence of apical periodontitis will be checked and non-surgical root canal treatment will be given to the patients with apical periodontitis and change in PAI score, eGFR & Systemic markers will be checked	Biological: systemic inflammatory marker, Oral health status, apical periodontitis; estimation of hs-CRP levels, and assessment of Oral health status, apical periodontitis

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Periapical Index(PAI)	Periodical status will be assessed in periodical radiograph and scoring of periapical index will be done according to size and periphery of peri-apical radiolucency with coding 1 to 5	1 year
eGFR	BY BLOOD SAMPLE measured in mL/min/1.73m2	1 year
serum creatinine	BY BLOOD SAMPLE measured in mg/dL	1 year
hs-CRP	HIGH SENSITIVE C-reactive protein measured by ELISA kit in mg/L	1 year
Blood urea	measured by collecting blood sample in mg/dL	1 year

Collaborators and Investigators

• Sponsor: Postgraduate Institute of Dental Sciences Rohtak
• Investigators: Study Director: Dr. Shweta Mittal, MDS, Post Graduate Institute Of Dental Sciences, Rohtak.

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2021
• Primary Completion (Actual): December 31, 2022
• Study Completion (Actual): December 31, 2022

Study Registration Dates

• First Submitted: December 11, 2021
• First Submitted That Met QC Criteria: April 17, 2023
• First Posted (Actual): April 19, 2023

Study Record Updates

• Last Update Posted (Actual): April 19, 2023
• Last Update Submitted That Met QC Criteria: April 17, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Keywords: Apical Periodontitis; Root Canal Treatment
• Additional Relevant MeSH Terms: Urologic Diseases; Renal Insufficiency; Kidney Diseases; Renal Insufficiency, Chronic
• Other Study ID Numbers: Dr. Jyoti Lamba

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No