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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
Full description
The aim of the current study is to evaluation and comparsion between two different paediatric rotary file systems (Kedo S plus file and Kidzo File) and Manual K-file both clinically and radiographically
Primary Objective:
Evaluation of clinical success, instrumentation time and quality of obturation of two different paediatric rotary file systems and manual K-file system in pulpectomy in primary molars both clinically and radiographically (In-vivo part of the study).
Testing hypothesis:
The null hypothesis (H 0 ): there is no difference in clinical success, instrumentation time ,quality of obturation and apical debris extrusion between the two different pediatric rotary systems and manual K-file system in pulpectomy in primary molars
PICOTS:
P - Participants: Children in the age group of 4-7 years having pulpally involved Primary teeth indicated for pulpectomy, I - Intervention: Pulpectomy procedure in primary molars using Kedo S plus file and Kidzo file.
C - Comparison: Manual K-file.
O- Outcomes:
The predicted sample size was found to be 30 teeth (10 teeth per group) which was calculated by using G*Power version 3.1.9.7. Sample size will be increased by about 10% to compensate for the drop out.
Selection of primary molars, of 4 to 7 year old patients, following the inclusion criteria N=30
All Participant will be a randomly allocated into one of the either group (10 teeth in 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)
Pre-operative intraoral periapical radiograph for assessing the root structure and confirming the diagnosis of pulpal involvment
Pulpectomy of primary molars according the protocol of individual group
• Materials and Clinical procedures
In this study, the following materials will be used:
Manual K-file
Two different rotary paediatric file
Endomotor with apexolocator
Calcium hydroxide with iodoform paste
Polymer Reinforced ZOE Cement (IRM)
Glass Ionomer Cement
Stainless Steel Crown Clinical procedure Group 1: (Kedo S plus file study group)
Group 2: (Kidzo-file study group) Steps 1-7 will be done as mentioned above. Then, Kidzo file will be used for instrumentation according to manufacturer's instructions. Step 9-14 also, will be repeated as well.
Group 3: (Manual K-file control group) Steps 1-7 will be done as mentioned above also. Then, the teeth will be instrumented by using hand k-files. Again step 9-14 will be repeated as well.
Follow-up The patients will be recalled for clinical and radiographic follow up after 1, 3, 6 and 12 months.
Outcome measurement
Immediate post operative
A-The instrumentation time:
Will be recorded using a digital stopwatch, which include only instrumentation time of the used files excluding the in-between irrigation protocol for assessing the accurate time period needed for instrumentation in each group.
B-The quality of obturation:
Will be assessed according to criteria of Coll and Sadrian (1996) as (Underfilled, Optimal filled or Overfilled) by using intraoral periapical radiograph by paralleling technique.
Through the follow up period:
Clinical and radiographic success The following table indicating to the clinical and radiographic Coll and Sadrian.
criteria for treatment success,(1996) (44) : Clinical criteria Radiographic criteria 1. Absence of pain on percussion on recall checkup 1. No pathologic root resorption 2. No gingival swelling or sinus tract 2. No widening of the periodontal ligament space 3. Absence of purulent exudate expressed from the gingival margin 3. Absence or decrease of any periapical or furcation involvement 4. No abnormal mobility of tooth
Blinding Participants and legal guardian will be blinded to which group they will be allocated , and the evaluator also will be blinded. While the operator /primary investigator cannot be blinded as she is already familiar with the type of the files used and their different instruction for using. For statistical analysis, codes will also assure blinding and confidentiality.
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
Exclusion criteria
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
Primary purpose
Allocation
Interventional model
Masking
30 participants in 3 patient groups
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Data sourced from clinicaltrials.gov
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