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

Endodontic Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04102293
• Other study ID #: PED19-2D
• Status: Completed
• Phase: N/A
• Start date: September 1, 2019
• Est. completion date: January 1, 2022

Study information

• Verified date: February 2023
• Source: British University In Egypt
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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:

Recruitment information / eligibility

• Status: Completed
• Enrollment: 41
• Est. completion date: January 1, 2022
• Est. primary completion date: December 1, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 4 Years to 7 Years

Eligibility

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.

Related Conditions & MeSH terms

• Dental Pulp Diseases
• Endodontic Disease

Intervention

Procedure:
• NSK Endo motor Endomate
Rotary instrumenation used in pulp therapy
• manual K-files
manual instrumentation used in pulp therapy

Locations

Country	Name	City	State
Egypt	Ain Shams Univeristy	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Reem Mahmoud Abdelkader Awad

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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