Time Efficiency and Obturation Quality of Rotary Versus Manual in Primary Teeth

Time Efficiency and Obturation Quality of Rotary Files Versus Manual Files in Pediatric Endodontics

The aim of this study is to evaluate the quality of obturation and the time efficiency of rotary versus manual instrumentation in roots of deciduous molars clinically where the:

• Primary objective Is to evaluate the time efficiency
• Secondary objective Is to evaluate the quality of obturation Clinical and radiographical follow up will be performed for 18 months to investigate the clinical and the radiographic success for the Conventional and Rotary groups.

Study Overview

• Status: Completed
• Conditions: Endodontic Disease
• Intervention / Treatment: Procedure: NSK Endo motor Endomate; Procedure: manual K-files

Detailed Description

The study will be conducted in two parts as follows:

In-vitro part as a training part to practice, test the speed of the rotary system, followed by application clinically.

Obturation will be done using two different filling techniques:

• Incremental filling Technique
• Disposable syringe Technique.

Then the instrumentation time and the quality of obturation will be recorded.

The study will be conducted by recruiting patients from the Outpatient clinic of The Pediatric Dentistry and Dental Public Health department, Faculty of Dentistry, Ain Shams University:

• Study Type: Interventional
• Enrollment (Actual): 41
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt, 02
    • Ain shams univeristy

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 4 years to 7 years (Child)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

-

Children included in the study should conform to the following criteria:

1. Patients between ages 4-7 years old with at least one mandibular vital or non-vital primary molar indicated for pulpectomy will be selected.
2. Absence of periapical or interadicular radiolucencies, inflammatory root resorption, sinus tract or gingival abscess.
3. No physiological root resorption.
4. The teeth should have enough coronal structure for full coverage Stainless-Steel crowns.

Exclusion Criteria:

• 1. Children who are extremely uncooperative and difficult to manage 2. Children suffering from any physically or mentally disability that will complicate the treatment: Special Health Care needs (SHCN) 3. Teeth of poor prognosis due to presence of an abscess or a sinus, mobility, advanced bone or root resorption or Non-Restorable teeth.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Rotary instrumentation using MM files 1; Rotary instrumentation using MM files (IMD Inc, China), sizes 20-25-30 taper 0.4, length 16 mm, then obturation with Zinc oxide and Eugenol using Incremental filling Technique.	Procedure: NSK Endo motor Endomate; Rotary instrumenation used in pulp therapy
Active Comparator: Manual instrumentation using K-files 1; Manual instrumentation using K-files (Mani Inc, Tochigi, Japan), sizes 15-20-25-30-35 then obturation with Zinc oxide and Eugenol using Incremental filling Technique.	Procedure: manual K-files; manual instrumentation used in pulp therapy
Experimental: Rotary instrumentation using MM files 2; Rotary instrumentation using MM files (IMD Inc, China), sizes 20-25-30 taper 0.4, length 16 mm, then obturation with Zinc oxide and Eugenol using Disposable syringe technique.	Procedure: NSK Endo motor Endomate; Rotary instrumenation used in pulp therapy
Active Comparator: Manual instrumentation using K-files 2; Manual instrumentation using K-files (Mani Inc, Tochigi, Japan), sizes 15-20-25-30-35 then obturation with Zinc oxide and Eugenol using Disposable syringe technique	Procedure: manual K-files; manual instrumentation used in pulp therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Is to evaluate the time efficiency of the rotary mm files versus manual stainless steel k files in the pulpectomy of lower second primary molars affecting the positive behavior of the child	Time efficiency of instrumentation using rotary mm files specially designed for primary teeth versus manual stainless steel K-files in the pulpectomy of mandibular second primary molars, by clinical and radiographic evaluation for 18 months.	up to 18 months
Is to evaluate and compare the quality of obturation using two different obturation techniques following instrumentation by rotary mm files and manual stainless steel k files instrumentation in another group	The quality of obturation using ZOE will be performed with either the incremental technique or the modified disposable syringe technique, following instrumentation by rotary and manual files, where the grading will be as : 1: overfilled, 2: underfilled 3: optimum filling.	up to 18 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Is to evaluate the time efficiency In vivo and In vitro	Comparing the Instrumentation time upon usage of Manual Instrumentation and Rotary Instrumentation in order to enhance patient cooperation.	up to 18 months

Collaborators and Investigators

• Sponsor: Reem Mahmoud Abdelkader Awad

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2019
• Primary Completion (Actual): December 1, 2021
• Study Completion (Actual): January 1, 2022

Study Registration Dates

• First Submitted: September 17, 2019
• First Submitted That Met QC Criteria: September 21, 2019
• First Posted (Actual): September 25, 2019

Study Record Updates

• Last Update Posted (Estimate): February 20, 2023
• Last Update Submitted That Met QC Criteria: February 7, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Keywords: rotatry instrumentation
• Additional Relevant MeSH Terms: Stomatognathic Diseases; Tooth Diseases; Dental Pulp Diseases
• Other Study ID Numbers: PED19-2D

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No