Clinical trial NCT06446011: Effects of RCT on Periapical Healing, Inflammatory Markers, and Kidney Function Indicators in CKD Patients With AP
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.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Apical Periodontitis
Chronic Kidney Diseases
Lead sponsor: Postgraduate Institute of Dental Sciences Rohtak
Sponsor class: OTHER
First posted: 2024-06-06
Enrollment: 74
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Periapical Index(PAI)
timeFrame: 12MONTHS
Secondary outcomes:
measure: eGFR
timeFrame: 3-6MONTHS
measure: serum creatinine
timeFrame: 3-6MONTHS
measure: hs-CRP
timeFrame: 3-6MONTHS
measure: Blood urea
timeFrame: 3-6MONTHS
Other outcomes:
Locations:
city: Rohtak
country: India
facility: PGIDS
state: Haryana
Study officials:
affiliation: PGIDS,ROHTAK
name: HIMANSHI VERMA, MDS
role: PRINCIPAL_INVESTIGATOR
References: