NCT06446011

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
74

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jul 2023

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 12, 2023

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

December 7, 2023

Completed
6 months until next milestone

First Posted

Study publicly available on registry

June 6, 2024

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2024

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

August 30, 2024

Completed
Last Updated

June 6, 2024

Status Verified

November 1, 2023

Enrollment Period

1.1 years

First QC Date

December 7, 2023

Last Update Submit

May 31, 2024

Conditions

Apical PeriodontitisChronic Kidney Diseases

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (4)

  • eGFR

    3-6MONTHS

  • serum creatinine

    3-6MONTHS

  • hs-CRP

    3-6MONTHS

  • Blood urea

    3-6MONTHS

Study Arms (2)

Chronic kidney disease group

EXPERIMENTAL

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.

Procedure: root canal treatment in Ckd patients

Healthy group

ACTIVE COMPARATOR

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

Procedure: root canal treatment in healthy patients

Interventions

root canal treatment in Ckd patientsPROCEDURE

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

Chronic kidney disease group
root canal treatment in healthy patientsPROCEDURE

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

Healthy group

Eligibility Criteria

Age18 Years+
Sexall(Gender-based eligibility)
Gender Eligibility DetailsGender matched healthy control participants to the same gender chronic kidney disease individuals will be analyzed.
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Patients having systemic disorders other than chronic kidney disease (e.g HIV; Diabetes mellitus; Coronary heart disease; no history of secondary hyperparathyroidism)
  • Patients with periodontitis , pocket depth and CAL\>5mm( stage 3 ,4) will be excluded.
  • Pregnancy; lactation \& contraceptives.
  • Patients taking antibiotics, statins, corticosteroids and aspirin which can affect the level of inflammatory markers in past one month.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

PGIDS

Rohtak, Haryana, 121004, India

RECRUITING

MeSH Terms

Conditions

Periapical PeriodontitisRenal Insufficiency, Chronic

Condition Hierarchy (Ancestors)

Periapical DiseasesJaw DiseasesStomatognathic DiseasesPeriodontal DiseasesMouth DiseasesPeriodontitisRenal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • HIMANSHI VERMA, MDS

    PGIDS,ROHTAK

    PRINCIPAL INVESTIGATOR

Central Study Contacts

SHWETA MITTAL, MDS

CONTACT

9255596960shwetagoelendo@gmail.com

SANJAY TEWARI, MDS

CONTACT

01262-283876principalpgids@yahoo.in

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 7, 2023

First Posted

June 6, 2024

Study Start

July 12, 2023

Primary Completion

July 31, 2024

Study Completion

August 30, 2024

Last Updated

June 6, 2024

Record last verified: 2023-11

Data Sharing

IPD Sharing
Will not share

Locations

IN(1)