Comparative Evaluation of Instrumentation Time Using Pediatric Rotary Versus Hand (Flare) File Systems

Comparative Evaluation of Instrumentation Time, Obturation Quality, and Child's Behavior Using Pediatric Rotary Versus Hand (Flare) File Systems in Treatment of Primary Molars: a Split Mouth Randomized Clinical Trial

The study will be conducted to evaluate instrumentation time, obturation quality, and child's behavior using pediatric rotary versus hand flare file systems in treatment of primary molars.

Study Overview

• Status: Not yet recruiting
• Conditions: Instrumentation Time
• Intervention / Treatment: Procedure: Pediatric rotary files; Procedure: Manual flare files

Detailed Description

Statement of the problem:

Pulpally affected primary teeth is a common problem in children due to lower mineralization, the presence of large pulp chamber with high pulp horns, and thin layers of enamel and dentin .

Manual files system is usually used for management of pulpally affected primary molars. This system has shown through the past years an acceptable clinical success rate but it also have many problems such as long visit time affecting the child behavior and causing fatigue to the dentist, difficulty in dealing with thin and curved canals due to limited flexibility of manual files causing incomplete removal of pulp tissue, and also difficulty in the determination of the actual working length due to the presence of physiologic and pathologic root resorption.

Rationale for conducting the research:

Pulp therapy in primary molars becomes compromised sometimes after delayed treatment due to dental neglect of children till caries progression to the pulp leading to severe symptoms associated with excessive pulp inflammation, root resorption, or periradicular bone resorption with a less favorable prognosis for conventional endodontic therapy. In the current era, a new perspective which is less time consuming with an acceptable success rate could be a spark of hope for the pediatric patient as well as the dentists.

Many studies were done comparing manual vs pediatric rotary files but without definitive conclusion. So further studies should be done with higher sample size to determine the superiority of one system over the other.

Benefits for the practitioner:

• Providing new and alternative treatment options.
• Shorter instrumentation time.
• Less fatigue.
• Better preparation of the canal.

Benefits for the patient:

• A faster and easier process leading to a more efficient dental procedure which could develop better outcomes in terms of success.
• Improvement in patient as well as parent satisfaction.

Benefits for community:

• Using alternative technique that can be faster, with a better success rate.
• To boost overall oral health.

• Study Type: Interventional
• Enrollment (Anticipated): 23
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ahmed W Ismael, Master; Phone Number: +21114036028; Email: ahmed.ismael@dentistry.cu.edu.eg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 4 years to 6 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

Children:

• Cooperative children.
• 4-6 years old children.
• Children who will attend follow up.

Teeth:

• Bilateral lower second primary molars.
• Pulpally involved molars indicated for pulpectomy.

Exclusion Criteria:

Children:

• Children with physical or emotional alteration.
• Children with systemic diseases.
• Children of parents who don't accept to participate in the study.

Teeth:

• Teeth with more than 1/3 of root resorption.
• Teeth with pathological mobility.
• Necrotic teeth with periapical or furcal lesions.
• Non restorable teeth.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Pediatric rotary files; Biomechanical preparation will be done using pediatric rotary file system (Kedo-SG blue file system). D1 and E1 files will be used at 300 rpm and 2.4 N/cm torque.	Procedure: Pediatric rotary files; Mechanical preparation of primary tooth canals with pediatric rotary files
Active Comparator: Manual flare files; Biomechanical preparation will be done using manual flare files (Mani) No. 15-35.	Procedure: Manual flare files; Mechanical preparation of primary tooth canals with manual flare files

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Instrumentation time	Continuous outcome measured by digital stopwatch in minutes	during procedure

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Child's behaviour	Using modified frankel scale from 1-5, where scale 1 has the worse behavior and scale 5 has the best behavior	during procedure
Postoperative pain	Binary outcome reported by telephone call to the parents	7 days
Tenderness to percussion	Binary outcome measured by percussion test using back of the dental mirror	1 year
Pain on biting	Binary outcome reported by the patient at biting	1 year
Swelling/ fistula / sinus tract	Binary outcome measured with visual examination of the patient	1 year
Mobility	Binary outcome measured by mobility test using back of the two dental mirrors	1 year
Internal or external root resorption	Binary outcome using digital radiograph	1 year
Furcation involvement or periapical radiolucency	Binary outcome using digital radiograph	1 year

Collaborators and Investigators

• Sponsor: Cairo University
• Investigators: Study Director: Manal A Elsayed, Professor, Cairo University

Study record dates

Study Major Dates

• Study Start (Anticipated): January 1, 2023
• Primary Completion (Anticipated): January 1, 2024
• Study Completion (Anticipated): March 1, 2024

Study Registration Dates

• First Submitted: December 6, 2022
• First Submitted That Met QC Criteria: December 17, 2022
• First Posted (Actual): December 27, 2022

Study Record Updates

• Last Update Posted (Actual): December 27, 2022
• Last Update Submitted That Met QC Criteria: December 17, 2022
• Last Verified: December 1, 2022

More Information

Terms related to this study

• Keywords: Rotary files; Manual flare files
• Other Study ID Numbers: Pediatric rotary files

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: Data may be provided upon request

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No