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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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05665803
Enrollment
23
Registered
2022-12-27
Start date
2023-01-01
Completion date
2024-03-01
Last updated
2022-12-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Instrumentation Time

Keywords

Rotary files, Manual flare files

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.

Interventions

PROCEDUREPediatric rotary files

Mechanical preparation of primary tooth canals with pediatric rotary files

PROCEDUREManual flare files

Mechanical preparation of primary tooth canals with manual flare files

Sponsors

Cairo University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)

Intervention model description

Split mouth RCT

Eligibility

Sex/Gender
ALL
Age
4 Years to 6 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Instrumentation timeduring procedureContinuous outcome measured by digital stopwatch in minutes

Secondary

MeasureTime frameDescription
Postoperative pain7 daysBinary outcome reported by telephone call to the parents
Tenderness to percussion1 yearBinary outcome measured by percussion test using back of the dental mirror
Pain on biting1 yearBinary outcome reported by the patient at biting
Child's behaviourduring procedureUsing modified frankel scale from 1-5, where scale 1 has the worse behavior and scale 5 has the best behavior
Mobility1 yearBinary outcome measured by mobility test using back of the two dental mirrors
Internal or external root resorption1 yearBinary outcome using digital radiograph
Furcation involvement or periapical radiolucency1 yearBinary outcome using digital radiograph
Swelling/ fistula / sinus tract1 yearBinary outcome measured with visual examination of the patient

Contacts

Primary ContactAhmed W Ismael, Master
ahmed.ismael@dentistry.cu.edu.eg+21114036028

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026