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

Primary Purpose

Endodontic Disease

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
NSK Endo motor Endomate
manual K-files
Sponsored by
Reem Mahmoud Abdelkader Awad
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Endodontic Disease focused on measuring rotatry instrumentation

Eligibility Criteria

4 Years - 7 Years (Child)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Ain Shams Univeristy

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Active Comparator

Experimental

Active Comparator

Arm Label

Rotary instrumentation using MM files 1

Manual instrumentation using K-files 1

Rotary instrumentation using MM files 2

Manual instrumentation using K-files 2

Arm Description

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.

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.

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.

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

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

Full Information

First Posted
September 17, 2019
Last Updated
February 7, 2023
Sponsor
Reem Mahmoud Abdelkader Awad
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1. Study Identification

Unique Protocol Identification Number
NCT04102293
Brief Title
Time Efficiency and Obturation Quality of Rotary Versus Manual in Primary Teeth
Official Title
Time Efficiency and Obturation Quality of Rotary Files Versus Manual Files in Pediatric Endodontics
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Completed
Study Start Date
September 1, 2019 (Actual)
Primary Completion Date
December 1, 2021 (Actual)
Study Completion Date
January 1, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Reem Mahmoud Abdelkader Awad

4. Oversight

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

5. Study Description

Brief Summary
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.
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:

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Endodontic Disease
Keywords
rotatry instrumentation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
41 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Rotary instrumentation using MM files 1
Arm Type
Experimental
Arm Description
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.
Arm Title
Manual instrumentation using K-files 1
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Rotary instrumentation using MM files 2
Arm Type
Experimental
Arm Description
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.
Arm Title
Manual instrumentation using K-files 2
Arm Type
Active Comparator
Arm Description
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
Intervention Type
Procedure
Intervention Name(s)
NSK Endo motor Endomate
Intervention Description
Rotary instrumenation used in pulp therapy
Intervention Type
Procedure
Intervention Name(s)
manual K-files
Intervention Description
manual instrumentation used in pulp therapy
Primary Outcome Measure Information:
Title
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
Description
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.
Time Frame
up to 18 months
Title
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
Description
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.
Time Frame
up to 18 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
4 Years
Maximum Age & Unit of Time
7 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: - Children included in the study should conform to the following criteria: Patients between ages 4-7 years old with at least one mandibular vital or non-vital primary molar indicated for pulpectomy will be selected. Absence of periapical or interadicular radiolucencies, inflammatory root resorption, sinus tract or gingival abscess. No physiological root resorption. 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.
Facility Information:
Facility Name
Ain Shams Univeristy
City
Cairo
ZIP/Postal Code
02
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
No

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

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