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Assessment of Clinical & Radiographic Efficiency of Manual & Pediatric Rotary Systems in Primary Root Canal Preparation

Primary Purpose

Manual; Rotation, Obturation, Post Operative Pain

Status
Recruiting
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
pulpectomy procedure
Post-operative Cone Beam Computed Tomography
Post-operative pain assessment
Sponsored by
Tanta University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Manual; Rotation focused on measuring Cone-beam computed tomography, kedo-S square, Fanta AF™ Baby

Eligibility Criteria

4 Years - 7 Years (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria: healthy cooperative children non-vital posterior teeth with sufficient coronal structure intact 2/3rd root structure no mobility or external pathological root resorption Exclusion Criteria: Uncooperative children children with systemic illness non-restorable primary molars primary molars with sever mobility, or pathological root resorption

Sites / Locations

  • Tanta UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Active Comparator

Arm Label

group 1: Kedo-S Square rotary files

group II: Fanta AFTM-Baby rotary system

group III: manual K-files

Arm Description

Primary root canals(n=20) were instrumented using rotary P1 Kedo-S Square files (Reeganz Dental Care Pvt. Ltd. India) at 300 rpm and 2.2N cm torque. The rotary files were used with an Endo-Mate DT endodontic motor (NSK, Tokyo, Japan) and EDTA gel 17% (Meta Biomed Co. Ltd, Chungbuk, Korea) was used before instrumentation.

Primary root canals(n=20) were instrumented using Fanta AFTM-Baby rotary system (Shanghai Fanta Dental Materials, SUNGO Certification Company Limited, London, England) at 350 rpm and 2 N cm torque. Four files were used sequentially in the following order; open file #17/0.08, #20/0.04 yellow, #25/0.04 red and #30/0.04 blue. The rotary files were used with an Endo-Mate DT endodontic motor (NSK, Tokyo, Japan) and EDTA gel 17% (Meta Biomed Co. Ltd, Chungbuk, Korea) was used before instrumentation.

Primary root canals(n=20) were instrumented using No.15 till 35 size manual K-files (Mani, Inc, Japan) using the quarter-turn-pull technique.

Outcomes

Primary Outcome Measures

Root canal preparation using Manual and Pediatric Rotary File Systems during pulpectomy of primary teeth
by evaluation of the obturation quality using immediate post-operative CBCT which is assessed by two trained pediatric dentists, blinded to instrumentation technique . The quality of obturation was assessed by evaluating the length of the Metapex filling according to Coll and Sadrian criteria : Under filling (Score 1): Canal filled with metapex more than 2 mm short of the apex. Optimal filling (Score 2): Canal filling ending at the radiographic apex or up to 2 mm short of apex. Overfilling (Score 3): Any canal showing filling outside the root apex.

Secondary Outcome Measures

postoperative pain after primary teeth pulpectomy using Manual and Pediatric Rotary File Systems
using four-point pain intensity scale. This scale categorizes pain as follows: (1) no pain; (2) slight pain; (3) moderate pain; and (4) severe pain. The parents of the children were given a questionnaire to record the intensity of postoperative pain at six, twelve, twenty-four and forty-eight hours after the pulpectomy procedure. A nursing officer who was blind to the study groups, had trained all parents on how to record the postoperative pain. To ensure standardization, the same parent was asked to record the child's pain intensity at all time intervals. To reduce the possibility of the parents failing to record the pain at a given time, the investigator also recorded findings via telephonic conversation with the parents.

Full Information

First Posted
November 9, 2022
Last Updated
July 2, 2023
Sponsor
Tanta University
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1. Study Identification

Unique Protocol Identification Number
NCT05619796
Brief Title
Assessment of Clinical & Radiographic Efficiency of Manual & Pediatric Rotary Systems in Primary Root Canal Preparation
Official Title
Assessment of Clinical and Radiographic Efficiency of Manual and Pediatric Rotary File Systems in Primary Root Canal Preparation
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 4, 2022 (Actual)
Primary Completion Date
March 4, 2023 (Actual)
Study Completion Date
July 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Tanta University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
Manual files used for the pulpectomy of primary teeth have some disadvantages such as time wastage and the occurrence of iatrogenic errors compared to rotary systems. Little studies have been done to clinically evaluate the Kedo-S Square & Fanta AF™ Baby rotary systems in relation to the quality of obturation, instrumentation time and postoperative pain in root canal preparation of primary molars using CBCT.
Detailed Description
Biomechanical preparation is one of the most important steps of primary teeth pulpectomy, which are primarily targeted during canal debridement . Conventionally, hand files were used for cleaning and shaping in primary teeth with some disadvantages such as time wastage and the occurrence of iatrogenic errors such as zipping, lateral perforations, apical obstruction, and canal transportation. The use of rotary instruments for primary tooth instrumentation is faster, affordable, and yields consistent, reliable results. Numerous rotary endodontic systems designed primarily for application in permanent teeth, have been suggested for primary teeth root canal preparation. Since the primary teeth have a ribbon-shaped anatomy and shorter, thinner curved roots than permanent teeth, the use of these files in pulpectomy of primary teeth could produce lateral perforations. As a result, there was a great need for the development of a unique pediatric rotary file system. The Kedo-S Square rotary system is a single file system specifically designed for paediatric use. It consists of two files, one for anterior primary teeth (A1) and one for posterior primary teeth (P1) also, Fanta AF™-Baby rotary system, another specifically generated paediatric rotary file, was produced using Ni-Ti controlled memory (CM)-Wire technology. A good root canal treatment in primary teeth is dependent on the quality of biomechanical preparation, the type of obturating material used with as few voids as possible, and the achievement of a good hermetic seal. Also, treatment time is an important aspect as reduced chairside time increases children's cooperation for dental treatment, reduces anxiety, and making the treatment protocol optimal. Another factor affecting the success of primary teeth pulpectomy is the postoperative pain which may be due to extrusion of foreign particles into peri-radicular tissues accordingly, causing inflammation and releasing inflammatory mediators.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Manual; Rotation, Obturation, Post Operative Pain
Keywords
Cone-beam computed tomography, kedo-S square, Fanta AF™ Baby

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
A randomized, controlled prospective clinical study
Masking
ParticipantOutcomes Assessor
Masking Description
the quality of root canal filling by two trained pediatric dentists, blinded to instrumentation technique. A nursing officer who was blind to the study groups, had trained all parents on how to record the postoperative pain.
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
group 1: Kedo-S Square rotary files
Arm Type
Experimental
Arm Description
Primary root canals(n=20) were instrumented using rotary P1 Kedo-S Square files (Reeganz Dental Care Pvt. Ltd. India) at 300 rpm and 2.2N cm torque. The rotary files were used with an Endo-Mate DT endodontic motor (NSK, Tokyo, Japan) and EDTA gel 17% (Meta Biomed Co. Ltd, Chungbuk, Korea) was used before instrumentation.
Arm Title
group II: Fanta AFTM-Baby rotary system
Arm Type
Experimental
Arm Description
Primary root canals(n=20) were instrumented using Fanta AFTM-Baby rotary system (Shanghai Fanta Dental Materials, SUNGO Certification Company Limited, London, England) at 350 rpm and 2 N cm torque. Four files were used sequentially in the following order; open file #17/0.08, #20/0.04 yellow, #25/0.04 red and #30/0.04 blue. The rotary files were used with an Endo-Mate DT endodontic motor (NSK, Tokyo, Japan) and EDTA gel 17% (Meta Biomed Co. Ltd, Chungbuk, Korea) was used before instrumentation.
Arm Title
group III: manual K-files
Arm Type
Active Comparator
Arm Description
Primary root canals(n=20) were instrumented using No.15 till 35 size manual K-files (Mani, Inc, Japan) using the quarter-turn-pull technique.
Intervention Type
Procedure
Intervention Name(s)
pulpectomy procedure
Intervention Description
single visit pulpectomy was performed under strict aseptic conditions by a single operator. Peri-operative evaluation was done using intraoral digital senso. The teeth were anesthetized with 2% mepivacaine with 1:20,000 levonordefrin & isolated using rubber dam. caries was removed using no. 330 round carbide burs in high-speed contra angle headpiece. Access opening was gained & the roof of the pulp chamber was removed. Working length was determined by apex locator, then confirmed by periapical radiograph. Working length will be determined 1 mm shorter than apex. mechanical preparation was done using the tested files according to each group. Then, canals were irrigated with 1% sodium hypochlorite between each file followed by irrigation with normal saline. The root canals were dried using paper points & root canals were filled with Metapex. Intermediate restorative material was placed, and the tooth was restored with a preformed stainless-steel crown in the same appointment.
Intervention Type
Radiation
Intervention Name(s)
Post-operative Cone Beam Computed Tomography
Other Intervention Name(s)
Obturation Quality Assessment
Intervention Description
post-operative CBCT image was taken after completing the procedure with fixed exposure parameters (120 Kv, 5mA and 0.125mm voxel size) using smallest field of view (8D, 8Hcm) to improve spatial resolution. The CBCT images were obtained by using 3D module of On Demand Dental software (version 1.0 (build 1.0.10.7462),× 64 Edition, copyright 2004-2017 Cybermed, Korea and license key 670094709). The Immediate post-operative CBCT was taken to evaluate the quality of root canal filling by two trained pediatric dentists, blinded to instrumentation technique .
Intervention Type
Other
Intervention Name(s)
Post-operative pain assessment
Intervention Description
The parents of the children were given a questionnaire to record the intensity of postoperative pain at six, twelve, twenty-four and forty-eight hours after the pulpectomy procedure. A nursing officer who was blind to the study groups, had trained all parents on how to record the postoperative pain. The four-point pain intensity scale was used to record postoperative pain (figure 5). This scale categorizes pain as follows: (1) no pain; (2) slight pain; (3) moderate pain; and (4) severe pain. To ensure standardization, the same parent was asked to record the child's pain intensity at all time intervals. To reduce the possibility of the parents failing to record the pain at a given time, the investigator also recorded findings via telephonic conversation with the parents. The children returned to the department two days after the pulpectomy procedure with their completed questionnaire form.
Primary Outcome Measure Information:
Title
Root canal preparation using Manual and Pediatric Rotary File Systems during pulpectomy of primary teeth
Description
by evaluation of the obturation quality using immediate post-operative CBCT which is assessed by two trained pediatric dentists, blinded to instrumentation technique . The quality of obturation was assessed by evaluating the length of the Metapex filling according to Coll and Sadrian criteria : Under filling (Score 1): Canal filled with metapex more than 2 mm short of the apex. Optimal filling (Score 2): Canal filling ending at the radiographic apex or up to 2 mm short of apex. Overfilling (Score 3): Any canal showing filling outside the root apex.
Time Frame
2 days
Secondary Outcome Measure Information:
Title
postoperative pain after primary teeth pulpectomy using Manual and Pediatric Rotary File Systems
Description
using four-point pain intensity scale. This scale categorizes pain as follows: (1) no pain; (2) slight pain; (3) moderate pain; and (4) severe pain. The parents of the children were given a questionnaire to record the intensity of postoperative pain at six, twelve, twenty-four and forty-eight hours after the pulpectomy procedure. A nursing officer who was blind to the study groups, had trained all parents on how to record the postoperative pain. To ensure standardization, the same parent was asked to record the child's pain intensity at all time intervals. To reduce the possibility of the parents failing to record the pain at a given time, the investigator also recorded findings via telephonic conversation with the parents.
Time Frame
2 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
4 Years
Maximum Age & Unit of Time
7 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: healthy cooperative children non-vital posterior teeth with sufficient coronal structure intact 2/3rd root structure no mobility or external pathological root resorption Exclusion Criteria: Uncooperative children children with systemic illness non-restorable primary molars primary molars with sever mobility, or pathological root resorption
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
shaimaa eldesouky, lecturer
Phone
+201008994242
Email
shaimaaeldesouky@dent.tanta.edu.eg
First Name & Middle Initial & Last Name or Official Title & Degree
shimaa hadwa, lecturer
Phone
00201115535527
Email
shimaa.hadwa@dent.tanta.edu.eg
Facility Information:
Facility Name
Tanta University
City
Tanta
State/Province
Gharbia
ZIP/Postal Code
6624033
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shaimaa eldesouky, PhD
Phone
01008994242
Email
shiamaaeldesouky@dent.tanta.edu.eg
First Name & Middle Initial & Last Name & Degree
shimaa hadwa, PhD
Phone
00201115535527
Email
shimaa.hadwa@dent.tanta.edu.eg
First Name & Middle Initial & Last Name & Degree
shaimaa eldesouky, PhD

12. IPD Sharing Statement

Citations:
PubMed Identifier
10730297
Citation
Barr ES, Kleier DJ, Barr NV. Use of nickel-titanium rotary files for root canal preparation in primary teeth. Pediatr Dent. 2000 Jan-Feb;22(1):77-8.
Results Reference
background
PubMed Identifier
30003514
Citation
Jeevanandan G, Govindaraju L. Clinical comparison of Kedo-S paediatric rotary files vs manual instrumentation for root canal preparation in primary molars: a double blinded randomised clinical trial. Eur Arch Paediatr Dent. 2018 Aug;19(4):273-278. doi: 10.1007/s40368-018-0356-6. Epub 2018 Jul 12.
Results Reference
background
PubMed Identifier
35042489
Citation
Mohamed RH, Abdelrahman AM, Sharaf AA. Evaluation of rotary file system (Kedo-S-Square) in root canal preparation of primary anterior teeth using cone beam computed tomography (CBCT)-in vitro study. BMC Oral Health. 2022 Jan 18;22(1):13. doi: 10.1186/s12903-021-02021-0.
Results Reference
background
PubMed Identifier
35641977
Citation
Abd El Fatah YAM, Khattab NMA, Gomaa YF, Elheeny AAH. Cone-beam computed tomography analysis of primary root canals transportation and dentin loss after instrumentation with two-pediatric rotary files. BMC Oral Health. 2022 May 31;22(1):214. doi: 10.1186/s12903-022-02245-8.
Results Reference
background
PubMed Identifier
35152509
Citation
Elheeny AAH, Abdelmotelb MA. Postoperative pain after primary molar pulpectomy using rotary or reciprocating single files: A superior, parallel, randomized clinical trial. Int J Paediatr Dent. 2022 Nov;32(6):819-827. doi: 10.1111/ipd.12959. Epub 2022 May 5.
Results Reference
background

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Assessment of Clinical & Radiographic Efficiency of Manual & Pediatric Rotary Systems in Primary Root Canal Preparation

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