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Status unknownNCT05665803Updated Dec 27, 2022

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

An interventional study of Pediatric rotary files and Manual flare files in Instrumentation Time, sponsored by Cairo University. Status unknown. Open to participants aged 4 Years to 6 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-12-27.

Sponsored by Cairo University · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Dec 2022), so the status shown — last known as Not yet recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
23
Allocation
Randomized
Ages
4 Years to 6 Years
Sex
All
01

Study 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.

Read the 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.
02

Conditions studied

  • Instrumentation Time

Keywords

  • Rotary files
  • Manual flare files
03

In context

Lead sponsor

Cairo University is the lead sponsor of 4,780 studies on the registry; 1,427 are open to participants now.

Of its 36 completed or terminated interventional studies of FDA-regulated products, 5 (14%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
4 Years to 6 Years
Sexes eligible
All
Accepts 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

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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
23 participants (estimated)

Study arms

  • 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

  • Active comparator
    Manual flare files

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

    Procedure: Manual flare files

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

06

What researchers measure

Primary outcomes

  1. Instrumentation time

    Continuous outcome measured by digital stopwatch in minutes

    Time frame: during procedure

Secondary outcomes

  1. Child's behaviour

    Using modified frankel scale from 1-5, where scale 1 has the worse behavior and scale 5 has the best behavior

    Time frame: during procedure

  2. Postoperative pain

    Binary outcome reported by telephone call to the parents

    Time frame: 7 days

  3. Tenderness to percussion

    Binary outcome measured by percussion test using back of the dental mirror

    Time frame: 1 year

  4. Pain on biting

    Binary outcome reported by the patient at biting

    Time frame: 1 year

  5. Swelling/ fistula / sinus tract

    Binary outcome measured with visual examination of the patient

    Time frame: 1 year

  6. Mobility

    Binary outcome measured by mobility test using back of the two dental mirrors

    Time frame: 1 year

  7. Internal or external root resorption

    Binary outcome using digital radiograph

    Time frame: 1 year

  8. Furcation involvement or periapical radiolucency

    Binary outcome using digital radiograph

    Time frame: 1 year

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: No — Data may be provided upon request

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 27, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05665803
Lead sponsor
Cairo University
Responsible party
Ahmed Wafik Ismael Mohamed (Assistant lecturer, department of pediatric dentistry, Cairo University) — Principal investigator
First posted
Dec 27, 2022
Start date
Jan 1, 2023 (estimated)
Primary completion
Jan 1, 2024 (estimated)
Completion
Mar 1, 2024 (estimated)
Last update
Dec 27, 2022

Study contacts

Ahmed W Ismael, Master
Contact
ahmed.ismael@dentistry.cu.edu.eg
+21114036028
Manal A Elsayed, Professor
study director · Cairo University

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Dec 2022. You cannot join it, but the record below documents what was studied.

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