Evaluation of Child's Behavior Using Single Rotary File System Versus Manual Instrumentation in Pulpectomy of Primary Molars - A Randomized Clinical Trial (RCT)
Overview
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Cairo University
- Enrollment
- 54
- Locations
- 1
- Primary Endpoint
- • child's behavior level
Overview
Brief Summary
The primary aim is to compare the behavior of the children during using conventional manual instrumentation versus rotary instrumentation by single rotary system for pulpectomy in primary molars through a Randomized Clinical Trial.
The main question it aims to answer is:
Is there a difference in the behavior of the children when using single rotary file system versus manual instrumentation in pulpectomy in primary molars?
Detailed Description
Pulpectomy has gained popularity in the pediatric dental practice for preserving the primary teeth in its position until exfoliation. There has been a paradigm shift from using manual instrumentation to rotary instrumentation for canal preparation in primary teeth. While studies show that there is a reduction in the instrumentation time with the use of rotary instruments which in turn influences the behavior of the child, its direct effect on the behavior of the children has not been evaluated .
The behavior of children plays an integral component and is the primary requisite of the pediatric dental practice. Assessment of child's behavior during a dental procedure is one of the most important skills of a pediatric dentist for successful completion of the dental treatment .
Interestingly, it has been noted that the treatment duration of patients with anxiety or behavior management problem is on average 40% more than that of normal patients going through the same procedure .
Much attention has been directed toward making pulpectomy a less time-consuming and a more-efficient procedure. These challenges lead to the introduction of rotary endodontics in pediatric dentistry. However, the bizarre root canal morphology and thinner root dentin limited the use of rotary endodontics in primary teeth. Various modified protocols have been introduced to overcome such barriers to prevent undesirable complications.
With these options, dentists can perform the pulpectomy with less psychological trauma to the child thus decreasing the anxiety and instilling positive behavior. The acceptance rate of the proposed method of treatment by the child may also increase. Furthermore, the use of a rotary file system may maintain a balance between the treatment duration and efficient behavior management in children.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Outcomes Assessor)
Masking Description
The blinding of the operator is not possible due to the nature of the technique used.
Eligibility Criteria
- Ages
- 4 Years to 6 Years (Child)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Patients:
- •Aged 4-6years, Medically free and Cooperative.
- •Restorable mandibular second primary molars with clinical signs or symptoms of irreversible pulpitis.
- •Pre-operative Radiographic criteria:
- •Absence of internal or external root resorption.
- •Absence of periapical or inter-radicular radiolucencies.
Exclusion Criteria
- •Patients:
- •Uncooperative children.
- •Children with systemic disease.
- •Physical or mental disabilities.
- •Refusal of participation.
- •Unable to attend follow- up visits.
- •Refusal to sign the informed consent.
- •Previously accessed teeth.
- •Mobile mandibular primary molars.
- •Pain on percussion.
Arms & Interventions
Group I pulpectomy using single rotary file system
Administration of local anesthesia at the side of the affected tooth. Application of the rubber dam for isolation, then a standardized pulpectomy procedure will be performed using a large sterile round end bur in a high-speed hand piece with copious irrigation. After opening the access cavity, the root canal patency was checked for all the canals located using a size #10 (0.02%) k-file then a single rotary file (20 taper 4) will be adjusted on the desirable working length depending on an electronic apex locator (1 mm shorter than the apex) and used in pulpectomy in a brushing motion at the rotational speed 300 rpm with torque set at the lowest level, irrigation with saline.
Intervention: Fanta AF F one rotary files 20 taper 4 (Device)
Group II pulpectomy using manual files system
Administration of local anesthesia at the side of the affected tooth. Application of the rubber dam for isolation, then a standardized pulpectomy procedure will be performed using a large sterile round end bur in a high-speed hand piece with copious irrigation. After opening the access cavity, manual files (k files, Mani, Inc., Japan) size 15,20,25,30 will be adjusted on the desirable working length depending on an electronic apex locator (1 mm shorter than the apex) and used in pulpectomy in a brushing motion, irrigation with saline.
Intervention: Manual files (k files ,Mani, Inc., Japan). (Device)
Outcomes
Primary Outcomes
• child's behavior level
Time Frame: Immediately after treatment
child's behavior level using Frankl's behavior rating scale * rate 1 means definitely negative "refusal of treatment , fearfulness" * rate 2 means negative "reluctance to accept treatment , uncooperative" * rate 3 means positive "acceptance of treatment , patient follows the dentist's directions" * rate 4 means definitely positive " good rapport with the dentist , laughter and enjoyment"
Secondary Outcomes
- Post-operative pain(at 6, 12, 24, 48 and 72 hours and 1 week after treatment.)
- Obturation quality(Immediately after treatment.)
- Instrumentation time(During treatment)
Investigators
Amira Mohamed Ibrahim Mohamed Ibrahim
principal investigator
Cairo University