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Effects of RCT on Periapical Healing, Inflammatory Markers, and Kidney Function Indicators in CKD Patients With AP

Not Applicable
Recruiting
Conditions
Apical Periodontitis
Chronic Kidney Diseases
Interventions
Procedure: root canal treatment in healthy patients
Procedure: root canal treatment in Ckd patients
Registration Number
NCT06446011
Lead Sponsor
Postgraduate Institute of Dental Sciences Rohtak
Brief Summary

The purpose of this prospective study is to determine the effect of non-surgical root canal treatment in chronic kidney disease patients and healthy patients with apical periodontitis.

Detailed Description

It has been found that there is an association between prevalence of odontogenic infection and systemic diseases. An elevated level of systemic cytokines has been observed in conjunction with both AP and CKD . The proinflammatory status and impaired immune response associated with systemic diseases (chronic kidney disease ) can affect the reparative response of the dental pulp and periapical healing. One study observed significant positive relation between number of diagnosed AP and urea serum level . A 4.35-mg/dL increase in the urea serum level could be expected per 1-unit increase in the number of teeth with AP. Improving oral health care through nonsurgical endodontic treatment(NSET) may improve the systemic inflammatory status and improve renal function.

The aim of this prospective study is to determine the effect of non-surgical root canal treatment in chronic kidney disease patients and healthy patients with apical periodontitis

1. Clinical and radiographic success rate will be considered as primary outcome, will be checked at baseline,6months,12months follow up.Periapical status will be checked according to periapical index given by Orstavik

2. Reduction in inflammatory(hsCRP) and kidney makers(serum urea , creatinine , eGFR) will be considered as secondary outcome, will be checked at baseline,3months,6months follow up.

Recruitment & Eligibility

Status
RECRUITING
Sex
All
Target Recruitment
74
Inclusion Criteria

1- Known patient of Chronic Kidney Disease [CKD Stages 1,2,3,4,5 with mature permanent teeth.

  1. Age18year or older . 3. ≥ to 12 natural teeth (excluding 3rd molars) 4 The periapical index (PAI) was used to evaluate the periapical status patients with PAI ≥3 are included in the study.
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Exclusion Criteria
  1. Patients having systemic disorders other than chronic kidney disease (e.g HIV; Diabetes mellitus; Coronary heart disease; no history of secondary hyperparathyroidism)
  2. Patients with periodontitis , pocket depth and CAL>5mm( stage 3 ,4) will be excluded.
  3. Pregnancy; lactation & contraceptives.
  4. Patients taking antibiotics, statins, corticosteroids and aspirin which can affect the level of inflammatory markers in past one month.
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Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Healthy grouproot canal treatment in healthy patientsRoot canal treatment will be performed in teeth with apical periodontitis in healthy patients and change in PAI score and systemic markers will be checked
Chronic kidney disease grouproot canal treatment in Ckd patientsRoot canal treatment will be performed in teeth with apical periodontitis in chronic kidney disease patients and change in PAI score, eGFR and systemic markers will be checked.
Primary Outcome Measures
NameTimeMethod
Periapical Index(PAI)12MONTHS

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

Secondary Outcome Measures
NameTimeMethod
Blood urea3-6MONTHS

measured by collecting blood sample in mg/dL

eGFR3-6MONTHS

BY BLOOD SAMPLE measured in mL/min/1.73m2

hs-CRP3-6MONTHS

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

serum creatinine3-6MONTHS

BY BLOOD SAMPLE measured in mg/dL

Trial Locations

Locations (1)

PGIDS

🇮🇳

Rohtak, Haryana, India

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