Clinical trial NCT05619796: 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
Overall status: COMPLETED
Phase: NA
Conditions: Manual; Rotation
Obturation
Post Operative Pain
Keywords: Cone-beam computed tomography
kedo-S square
Fanta AF™ Baby
Lead sponsor: Tanta University
Sponsor class: OTHER
First posted: 2022-11-17
Enrollment: 60
Sex: ALL
Minimum age (years): 4
Maximum age (years): 7
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A randomized, controlled prospective clinical study
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Root canal preparation using Manual and Pediatric Rotary File Systems during pulpectomy of primary teeth
timeFrame: 2 days
Secondary outcomes:
measure: postoperative pain after primary teeth pulpectomy using Manual and Pediatric Rotary File Systems
timeFrame: 2 days
Other outcomes:
Locations:
city: Tanta
country: Egypt
facility: Tanta University
state: Gharbia
Study officials:
References:
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.
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.
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.
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.
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.