Association of Apical Periodontitis With Chronic Kidney Disease

Chronic Kidney Diseases Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05818657
• Other study ID #: Dr. Jyoti Lamba
• Status: Completed
• Start date: December 1, 2021
• Est. completion date: December 31, 2022

Study information

• Verified date: April 2023
• Source: Postgraduate Institute of Dental Sciences Rohtak
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 210
• Est. completion date: December 31, 2022
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Chronic Kidney Diseases
• Kidney Diseases
• Periapical Lesions
• Renal Insufficiency, Chronic

Intervention

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
• systemic inflammatory marker, Oral health status, apical periodontitis
estimation of hs-CRP levels, and assessment of Oral health status, apical periodontitis

Locations

Country	Name	City	State
India	PGIDS	Rohtak	Haryana

Sponsors (1)

Lead Sponsor	Collaborator
Postgraduate Institute of Dental Sciences Rohtak

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	eGFR	BY BLOOD SAMPLE measured in mL/min/1.73m2	1 year
Primary	serum creatinine	BY BLOOD SAMPLE measured in mg/dL	1 year
Primary	hs-CRP	HIGH SENSITIVE C-reactive protein measured by ELISA kit in mg/L	1 year
Primary	Blood urea	measured by collecting blood sample in mg/dL	1 year