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

NCT ID: NCT06446011

Last Updated: 2024-06-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

74 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-07-12

Study Completion Date

2024-08-30

Brief Summary

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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

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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.

Conditions

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Apical Periodontitis Chronic Kidney Diseases

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

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Chronic kidney disease group

Root 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.

Group Type EXPERIMENTAL

root canal treatment in Ckd patients

Intervention Type PROCEDURE

root canal treatment in teeth with apical periodontitis to observe periapical healing , and change in eGFR ,blood urea and creatinine and HSCRP

Healthy group

Root canal treatment will be performed in teeth with apical periodontitis in healthy patients and change in PAI score and systemic markers will be checked

Group Type ACTIVE_COMPARATOR

root canal treatment in healthy patients

Intervention Type PROCEDURE

root canal treatment in teeth with apical periodontitis to observe periapical healing and change in HSCRP

Interventions

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root canal treatment in Ckd patients

root canal treatment in teeth with apical periodontitis to observe periapical healing , and change in eGFR ,blood urea and creatinine and HSCRP

Intervention Type PROCEDURE

root canal treatment in healthy patients

root canal treatment in teeth with apical periodontitis to observe periapical healing and change in HSCRP

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

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

2\. 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.

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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Postgraduate Institute of Dental Sciences Rohtak

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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HIMANSHI VERMA, MDS

Role: PRINCIPAL_INVESTIGATOR

PGIDS,ROHTAK

Locations

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PGIDS

Rohtak, Haryana, India

Site Status RECRUITING

Countries

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India

Central Contacts

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SHWETA MITTAL, MDS

Role: CONTACT

9255596960

SANJAY TEWARI, MDS

Role: CONTACT

01262-283876

Facility Contacts

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HIMANSHI VERMA, MDS

Role: primary

7042836872

SHWETA MITTAL, MDS

Role: backup

9255596960

Other Identifiers

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Himanshi Verma

Identifier Type: -

Identifier Source: org_study_id

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