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Completed

NCT Number: NCT05818657

Association of Apical Periodontitis With Chronic 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.

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Key information

Conditions

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

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

PGIDS

Rohtak, Haryana, 124001, India

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

systemic inflammatory marker, Oral health status, apical periodontitis

Biological

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

Primary outcomes

  1. Periapical Index(PAI)

    Time frame: 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

  2. eGFR

    Time frame: 1 year

    BY BLOOD SAMPLE measured in mL/min/1.73m2

  3. serum creatinine

    Time frame: 1 year

    BY BLOOD SAMPLE measured in mg/dL

  4. hs-CRP

    Time frame: 1 year

    HIGH SENSITIVE C-reactive protein measured by ELISA kit in mg/L

  5. Blood urea

    Time frame: 1 year

    measured by collecting blood sample in mg/dL

Sponsors and collaborators

Lead sponsor

Postgraduate Institute of Dental Sciences Rohtak

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Apr 19, 2023
Registry last updated
Apr 19, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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