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

NCT ID: NCT05665803

Last Updated: 2022-12-27

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 23 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-01-01
• Study Completion Date: 2024-03-01

Brief Summary

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.

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.

Conditions

Instrumentation Time

Keywords

Rotary files; Manual flare files

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: EXPERIMENTAL

Pediatric rotary files

Intervention Type: PROCEDURE

Mechanical preparation of primary tooth canals with pediatric rotary files

Manual flare files

Biomechanical preparation will be done using manual flare files (Mani) No. 15-35.

Group Type: ACTIVE_COMPARATOR

Manual flare files

Intervention Type: PROCEDURE

Mechanical preparation of primary tooth canals with manual flare files

Interventions

Pediatric rotary files

Mechanical preparation of primary tooth canals with pediatric rotary files

Intervention Type: PROCEDURE

Manual flare files

Mechanical preparation of primary tooth canals with manual flare files

Intervention Type: PROCEDURE

Eligibility Criteria

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.

• Minimum Eligible Age: 4 Years
• Maximum Eligible Age: 6 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Cairo University

OTHER

Sponsor Role: lead

Responsible Party

Ahmed Wafik Ismael Mohamed

Assistant lecturer, department of pediatric dentistry

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Manal A Elsayed, Professor

Role: STUDY_DIRECTOR

Cairo University

Central Contacts

Ahmed W Ismael, Master

Role: CONTACT

Phone: +21114036028

Email: ahmed.ismael@dentistry.cu.edu.eg

Other Identifiers

Pediatric rotary files

Identifier Type: -

Identifier Source: org_study_id