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Clinical Trials/CTRI/2025/04/084040
CTRI/2025/04/084040Not yet recruitingNot Applicable

Evaluation of clinical efficiency of two single file NiTi rotary systems in performing root canal treatment in primary teeth.

Dr Lomada Lakshmidevi1 site in 1 country50 target enrollmentStarted: April 15, 2025Last updated:

Trial Snapshot

Phase
Not Applicable
Status
Not yet recruiting
Sponsor
Enrollment
50
Locations
1
Primary Endpoint
Quality of obturation

Study Overview

Brief Summary

Screening of 4-9 years old patients attending outpatient department will be done. Details of the study will be explained to the patients and parents, with written informed consent obtained. Based on inclusion and exclusion criteria a total of 50 primary teeth will be included and divided into 2 equal groups with n= 25 in each group. Group 1 includes Kedo-S and group 2 includes Xp-endoshaper. A standard protocol will be followed for pulpectomy and radiographic method of working length determination will be done. BMP will be done using respective rotary file systems in both the groups and instrumentation time will be recorded in seconds using stop watch, followed by irrigation using 2.5% sodium hypochlorite. Obturation will be done using zinc oxide eugenol cement. Quality of obturation will be assessed using post operative radiograph based on Coll and Sadrian criteria given in the year 1996. And it will be graded and scored as under fill (1), optimum fill (2), overfill (3), and presence or absence of voids. Obtained data will be subjected to statistical analysis.

Study Design

Study Type
Interventional
Allocation
Randomized
Masking
Participant and Outcome Assessor Blinded

Eligibility Criteria

Ages
4.00 Year(s) to 9.00 Year(s) (—)
Sex
All

Inclusion Criteria

  • Children between 4-9 years of age.
  • Pulpectomy requiring single or two visits.
  • Children without any systemic diseases.
  • Primary teeth with sinus tract,abscess but without any signs of resorption.
  • Cooperative child: Frankels positiveand definitely positive patients.

Exclusion Criteria

  • 1.Children with systemic diseases.
  • And those with special health care needs.
  • 2.Uncooperative patients 3.Multiple visit.

Outcomes

Primary Outcomes

Quality of obturation

Time Frame: The Quality of obturation will be assessed radiographically at 0 minutes immediately after the obturation (immediate post operative) on the same day

Secondary Outcomes

  • Instrumentation time(The time required for instrumentation will be measured at - Baseline)

Investigators

Sponsor
Dr Lomada Lakshmidevi
Sponsor Class
Other [self]
Responsible Party
Principal Investigator
Principal Investigator

Dr Lomada Lakshmidevi

Vishnu Dental College

Study Sites (1)

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