Evaluation of Different Paediatric Rotary Files and Manual K-file in Root Canal Treatment of Primary Teeth

NCT05234918 | Unknown

• 1 other identifier: PED 21-1D
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

Brief Summary

The aim of the current study is evaluation and comparsion between two different paediatric rotary file systems and Manual K-file both clinically and radiographically .This study consist of two parts:I-In vivo part (RCT) II-In vitro part The in-vivo part: Its sample size was found to be 30 primary molars (10 teeth for each group) Group1: Kedo S plus file study group (The teeth will be instrumented by Kedo S plus file) Group2: Kidzo file study group (The teeth will be instrumented by Kidzo file) Group3: Manual K-file control group (The teeth will be instrumented by Manual K-file) Pulpectomy of primary molars according the protocol of individual group will be made, after that the teeth will be evaluated Immediately for : 1-Instrumentation time 2-Quality of obturation and evaluated at 1, 3, 6, 12 months for clinical and radiographic success

Conditions

Root Canal Treatment

Outcome Measures

Primary Outcomes (3)

• clinical outcome through participant clinical examination

  Evaluation of participants with clinical success according to Coll and Sadrian criteria for treatment success No pain, No sweeling , No exudate, No abnormal mobility

  from baseline to 12 months

• The quality of obturation will be assessed by using periapical intra oral radiographic parallel technique

  the quality of obturation will be assessed from the obtained x - ray film by visual examination to evaluate it under the following categories: Under filled- Optimal filled- Over filled

  from baseline to 12 months

• Instrumentation time

  time of instrumentation will be measured immediatly by digital watch in seconds

  immediatly after procedure

Study Arms (3)

(Kedo S plus file study group)

EXPERIMENTAL

Group1: Kedo S plus file study group (The teeth will be instrumented by Kedo S plus file)

Device: Pediatric Rotary File Systems

(Kidzo-file study group)

EXPERIMENTAL

Group2: Kidzo file study group (The teeth will be instrumented by Kidzo file)

Device: Pediatric Rotary File Systems

(Manual K-file control group)

EXPERIMENTAL

Group3: Manual K-file control group (The teeth will be instrumented by Manual K-file)

Device: Pediatric Rotary File Systems

Interventions

Pediatric Rotary File Systems DEVICE

* Kedo S plus (p1 molar file ) (A1 anterior file) * Kidzo-file system 25/4 30/4 30/6

(Kedo S plus file study group); (Kidzo-file study group); (Manual K-file control group)

Eligibility Criteria

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

You may qualify if:

• Patients between the age of 4-7 years.
• Posterior primary mandibular molars with necrotic pulp or irreversible pulpitis indicated for pulpectomy .
• Presence of minimum 2/3rd root structure.
• Adequate restorable tooth structure for further placement of stainless steel crowns.
• Medically free patient.
• Patient able to visualize and understand the explained assent with no impairment.

You may not qualify if:

• Teeth of poor prognosis due to presence of an extensive mobility, advanced bone or root resorption.
• Uncooperative patient
• parents who refuse to sign informed consent to participate in the study

Sponsors & Collaborators

• Ain Shams University: lead

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assisting teatcher

Study Record Dates

• First Submitted: November 8, 2021
• First Posted: February 10, 2022
• Study Start: March 1, 2022
• Primary Completion: April 1, 2023
• Study Completion: January 1, 2024
• Last Updated: February 10, 2022

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will not share