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

Chronic Kidney Diseases Clinical Trial

Official title:

Potential Effects of Non-surgical Endodontic Treatment on Periapical Healing, Inflammatory Markers, and Kidney Function Indicators in Chronic Kidney Disease Patients With Apical Periodontitis- Interventional Study.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06446011
• Other study ID #: Himanshi Verma
• Status: Recruiting
• Phase: N/A
• Start date: July 12, 2023
• Est. completion date: August 30, 2024

Study information

• Verified date: November 2023
• Source: Postgraduate Institute of Dental Sciences Rohtak
• Contact: SHWETA MITTAL, MDS
• Phone: 9255596960
• Email: shwetagoelendo[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Recruiting
• Enrollment: 74
• Est. completion date: August 30, 2024
• Est. primary completion date: July 31, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Apical Periodontitis
• Chronic Kidney Diseases
• Kidney Diseases
• Periapical Periodontitis
• Periodontitis
• Renal Insufficiency, Chronic

Intervention

Procedure:
• 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
• root canal treatment in healthy patients
root canal treatment in teeth with apical periodontitis to observe periapical healing and change in HSCRP

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	12MONTHS
Secondary	eGFR	BY BLOOD SAMPLE measured in mL/min/1.73m2	3-6MONTHS
Secondary	serum creatinine	BY BLOOD SAMPLE measured in mg/dL	3-6MONTHS
Secondary	hs-CRP	HIGH SENSITIVE C-reactive protein measured by ELISA kit in mg/L	3-6MONTHS
Secondary	Blood urea	measured by collecting blood sample in mg/dL	3-6MONTHS