Radicular Dentin Remaining, Risk of Perforation and Canal Transportation in Manual Versus Rotary Instrumentation in Primary Molars

NCT04793308 | Completed

• 1 other identifier: 111120
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

Background: Root canal preparation techniques using manual instruments have found to be time-consuming and may lead to iatrogenic errors such as ledging, zipping, canal transportation, and apical blockage. To overcome this, much attention has been directed toward root canal preparation using nickel-titanium (NiTi)-rotary instruments. The flexibility and the instrument design of NiTi-rotary files allow it to closely follow the original root canal path. Aim: This in vitro study aims to compare the amount of dentin removal in primary molars instrumented with hand versus rotary files and the root canal transportation and risk of perforation using cone beam computed tomography (CBCT). Materials and Method: ( 20 ) extracted discarded mandibular second primary molars were selected to contribute in the study, having minimal apical resorption with presence of at least two-third remaining root structure with absence of visual perforating resorption. The teeth included in the study were stored in water or saline till the experimental time. The extracted primary molars were divided into two groups of the study: Group I was prepared with rotary instrumentation using ProTaper Next (Dentsply, Switzerland) and Group II was prepared by manual instrumentation using K type files. All the root canals (n=40) were prepared up to size 35 using the step-back technique. The teeth were subjected to CBCT scans for the evaluation of thickness of radicular dentin remaining, risk of perforation and canal transportation before and after instrumentation in the two groups at three different locations (2, 4 and 7 mm from the apex) . Dentin removal was calculated by superimposing images using the InVivo 5.1 software. Data were statistically analyzed using independent samples t test.

Conditions

Root Canal Infection

Keywords

Deciduous teeth; pulpectomy; root canal preparation; canal transportation,; Cone Beam Computerized Tomography.

Outcome Measures

Primary Outcomes (2)

• Radicular dentin remaining

  Assessment of dentin remaining by Cone Beam Computerized Tomography (CBCT)

  3 months

• Transportation of Root Canal

  Assessment of Root Canal Transportation by Cone Beam Computerized Tomography

  3 months

Secondary Outcomes (1)

• Risk of Perforation

  3 months

Study Arms (2)

Group (1); (ProTaper Next, Rotary system).

EXPERIMENTAL

Group I teeth were prepared with rotary instrumentation using ProTaper Next (Dentsply, Switzerland)

Other: Endodontic files

Group (2); K- files, Manual instruments.

EXPERIMENTAL

Group II root canals were prepared by manual instrumentation using K type files Mani, Japan).

Other: Endodontic files

Interventions

Endodontic files OTHER

Engine-driven nickel titanium Ni-Ti instruments

Group (1); (ProTaper Next, Rotary system).; Group (2); K- files, Manual instruments.

Eligibility Criteria

• Age: 3 Years - 7 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Extracted Second primary molars. Extracted second primary molars with at least 2/3 of root remaining or with minimal apical resorption.
• Extracted second primary molars without visual perforation resorption.

You may not qualify if:

• Exfoliated second primary molars. If pre assessment radiograph for extracted second primary molars reveals internal or external root resorption.
• Extracted second primary molars with extreme root curvature.

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Department of Pediatric Dentistry, Faculty of Dentistry, Cairo University

Cairo, 0022, Egypt

Location

Study Officials

• Rania Nasr, Assoc. Prof.

  Cairo University

  PRINCIPAL INVESTIGATOR

• Hany Sadek, Assoc. Prof.

  Cairo University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: March 4, 2021
• First Posted: March 11, 2021
• Study Start: December 1, 2020
• Primary Completion: March 1, 2021
• Study Completion: March 1, 2021
• Last Updated: March 11, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)