Association of Apical Periodontitis With Chronic Kidney Disease

Completed

• Conditions: Chronic Kidney Diseases; Periapical Lesions
• Interventions: Biological: systemic inflammatory marker, Oral health status, apical periodontitis; Biological: levels of CKD markers, Oral health status, apical periodontitis

• Registration Number: NCT05818657
• Lead Sponsor: Postgraduate Institute of Dental Sciences Rohtak

Brief Summary

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.

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 Timeline

• Study Start: 2021-12-01
• Study First Submitted: 2021-12-11
• Primary Completion: 2022-12-31
• Study Completion: 2022-12-31
• Status Verified: 2023-04
• Study First Submitted QC: 2023-04-17
• Last Update Submitted: 2023-04-17
• Study First Posted: 2023-04-19
• Last Update Posted: 2023-04-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 210

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Group-B Healthy individuals	systemic inflammatory marker, Oral health status, apical periodontitis	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
Group-A CKD patients	levels of CKD markers, Oral health status, apical periodontitis	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

Primary Outcome Measures

Name	Time	Method
serum creatinine	1 year	BY BLOOD SAMPLE measured in mg/dL
Blood urea	1 year	measured by collecting blood sample in mg/dL
Periapical Index(PAI)	1 year	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
eGFR	1 year	BY BLOOD SAMPLE measured in mL/min/1.73m2
hs-CRP	1 year	HIGH SENSITIVE C-reactive protein measured by ELISA kit in mg/L

Trial Locations

Locations (1)

PGIDS; 🇮🇳 Rohtak, Haryana, India