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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

41 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-09-01

Study Completion Date

2022-01-01

Brief Summary

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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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Detailed Description

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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:

Conditions

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Endodontic Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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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.

Group Type EXPERIMENTAL

NSK Endo motor Endomate

Intervention Type PROCEDURE

Rotary instrumenation used in pulp therapy

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.

Group Type ACTIVE_COMPARATOR

manual K-files

Intervention Type PROCEDURE

manual instrumentation used in pulp therapy

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.

Group Type EXPERIMENTAL

NSK Endo motor Endomate

Intervention Type PROCEDURE

Rotary instrumenation used in pulp therapy

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

Group Type ACTIVE_COMPARATOR

manual K-files

Intervention Type PROCEDURE

manual instrumentation used in pulp therapy

Interventions

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NSK Endo motor Endomate

Rotary instrumenation used in pulp therapy

Intervention Type PROCEDURE

manual K-files

manual instrumentation used in pulp therapy

Intervention Type PROCEDURE

Eligibility Criteria

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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.

Minimum Eligible Age

4 Years

Maximum Eligible Age

7 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes