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

NCT04102293 | Completed

• 1 other identifier: PED19-2D
• Study Type: interventional
• Target: 41
• Locations: 1 country
• Sites: 1

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.

Conditions

Endodontic Disease

Keywords

rotatry instrumentation

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (4)

Rotary instrumentation using MM files 1

EXPERIMENTAL

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

Manual instrumentation using K-files 1

ACTIVE COMPARATOR

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

Rotary instrumentation using MM files 2

EXPERIMENTAL

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

Manual instrumentation using K-files 2

ACTIVE COMPARATOR

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

Interventions

NSK Endo motor Endomate PROCEDURE

Rotary instrumenation used in pulp therapy

Rotary instrumentation using MM files 1; Rotary instrumentation using MM files 2

manual K-files PROCEDURE

manual instrumentation used in pulp therapy

Manual instrumentation using K-files 1; Manual instrumentation using K-files 2

Eligibility Criteria

• Age: 4 Years - 7 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• \. 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.

Sponsors & Collaborators

• Reem Mahmoud Abdelkader Awad: lead

Study Sites (1)

Ain Shams Univeristy

Cairo, 02, Egypt

Location

MeSH Terms

Conditions

Dental Pulp Diseases

Condition Hierarchy (Ancestors)

Tooth Diseases; Stomatognathic Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: assistant lecturer

Study Record Dates

• First Submitted: September 17, 2019
• First Posted: September 25, 2019
• Study Start: September 1, 2019
• Primary Completion: December 1, 2021
• Study Completion: January 1, 2022
• Last Updated: February 21, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)