Association of Apical Periodontitis With Chronic Kidney Disease

NCT05818657 | Completed DMC

• 1 other identifier: Dr. Jyoti Lamba
• Study Type: observational
• Target: 210
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Kidney Diseases; Periapical Lesions

Keywords

Apical Periodontitis; Root Canal Treatment

Outcome Measures

Primary Outcomes (5)

• 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

Study Arms (2)

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

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

Interventions

levels of CKD markers, Oral health status, apical periodontitis BIOLOGICAL

To observe levels of CKD markers :Levels of serum keratinise ,urea, eGFR, and assessment of Oral health status, apical periodontitis

Group-A CKD patients

systemic inflammatory marker, Oral health status, apical periodontitis BIOLOGICAL

estimation of hs-CRP levels, and assessment of Oral health status, apical periodontitis

Group-B Healthy individuals

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Postgraduate Institute of Dental Sciences Rohtak: lead

Study Sites (1)

PGIDS

Rohtak, Haryana, 124001, India

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood analysis for CRP, Serum ferritin, Albumin, Creatinine \& Urea

MeSH Terms

Conditions

Renal Insufficiency, Chronic; Periapical Periodontitis

Interventions

Health Status

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Periapical Diseases; Jaw Diseases; Stomatognathic Diseases; Periodontal Diseases; Mouth Diseases; Periodontitis

Intervention Hierarchy (Ancestors)

Demography; Population Characteristics; Epidemiologic Measurements; Public Health; Environment and Public Health

Study Officials

• Dr. Shweta Mittal, MDS

  Post Graduate Institute Of Dental Sciences, Rohtak.

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 11, 2021
• First Posted: April 19, 2023
• Study Start: December 1, 2021
• Primary Completion: December 31, 2022
• Study Completion: December 31, 2022
• Last Updated: April 19, 2023

Record last verified: 2023-04

Locations

IN (1)