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Completed

NCT Number: NCT04102293

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

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.

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Key information

Age range

4 year–7 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ain Shams Univeristy

Cairo, 02, Egypt

About this study

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:

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

NSK Endo motor Endomate

Procedure

Rotary instrumenation used in pulp therapy

manual K-files

Procedure

manual instrumentation used in pulp therapy

Primary outcomes

  1. 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 frame: up to 18 months

    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.

  2. 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

    Time frame: up to 18 months

    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.

Sponsors and collaborators

Lead sponsor

Reem Mahmoud Abdelkader Awad

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2021
Study completion
2022
First posted
Sep 25, 2019
Registry last updated
Feb 21, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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