Clinical Effectiveness of Single Rotary File Versus Multiple Rotary Files in Pulpectomy of Primary Molars : A Randomized Clinical Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Cairo University
- Enrollment
- 48
- Locations
- 1
- Primary Endpoint
- instrumentation time
Study Overview
Brief Summary
The aim of this study is to compare the clinical effectiveness of a single rotary file system versus a multiple rotary files system in pulpectomy of primary molars
Detailed Description
In pediatric dentistry, premature loss of necrotic primary molars has been a matter of great concern over the years.
In modern pedodontic practice, Pulpectomy is regarded as the choice modality of treatment for pulpally involved necrotic teeth.
Hand files are used for mechanical preparation of primary tooth during pulpectomy but it has been found to be time consuming and may negatively influence the child's behavior . 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.
Up to our knowledge, no clinical trials in the literature have been done to compare the clinical and radiographic success of single rotary file systems versus multiple rotary files systems when used in pulpectomy of primary molars. Thus, the present study aims to investigate the clinical effectiveness of those two techniques
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. Trial participants, outcome assessors and statistician will be blinded
Eligibility Criteria
- Ages
- 4 Years to 9 Years (Child)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Children Criteria:
- •Medically free .
- •Cooperative patient.
- •Molar criteria :
- •Mandibular second primary molar with clinical signs or symptoms of irreversible pulpitis
- •Radiographic criteria:
- •No evidence of internal/external pathologic root resorption.
- •With or without periapical or furcal lesion .
Exclusion Criteria
- •• Uncooperative children.
- •Children with systemic disease.
- •Lack of informed consent by the child patient's parent.
- •Refusal of participation.
Outcomes
Primary Outcomes
instrumentation time
Time Frame: during the operation
instrumentation time of pulpectomy using single rotary file by stopwatch
Secondary Outcomes
- obturation quality(immediately after the operation)
- child's cooperation level(baseline and during the operation)
Investigators
Mennat-Allah Eid Ahmed Elsayed
doctor , internal resident
Cairo University