Assessment of Clinical & Radiographic Efficiency of Manual & Pediatric Rotary Systems in Primary Root Canal Preparation
- Conditions
- Manual; RotationObturationPost Operative Pain
- Interventions
- Procedure: pulpectomy procedureRadiation: Post-operative Cone Beam Computed TomographyOther: Post-operative pain assessment
- Registration Number
- NCT05619796
- Lead Sponsor
- Tanta University
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 60
- healthy cooperative children
- non-vital posterior teeth with sufficient coronal structure
- intact 2/3rd root structure
- no mobility or external pathological root resorption
- Uncooperative children
- children with systemic illness
- non-restorable primary molars
- primary molars with sever mobility, or pathological root resorption
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description group 1: Kedo-S Square rotary files Post-operative pain assessment 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. group 1: Kedo-S Square rotary files pulpectomy procedure 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. group II: Fanta AFTM-Baby rotary system Post-operative Cone Beam Computed Tomography 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. group III: manual K-files Post-operative Cone Beam Computed Tomography 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. group 1: Kedo-S Square rotary files Post-operative Cone Beam Computed Tomography 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. group II: Fanta AFTM-Baby rotary system Post-operative pain assessment 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. group III: manual K-files pulpectomy procedure 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. group III: manual K-files Post-operative pain assessment 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. group II: Fanta AFTM-Baby rotary system pulpectomy procedure 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 Outcome Measures
Name Time Method Root canal preparation using Manual and Pediatric Rotary File Systems during pulpectomy of primary teeth 2 days 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
Name Time Method postoperative pain after primary teeth pulpectomy using Manual and Pediatric Rotary File Systems 2 days 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.
Trial Locations
- Locations (1)
Tanta University
🇪🇬Tanta, Gharbia, Egypt