CTRI/2024/06/068867RecruitingPhase 2/3
Evaluating Obturation Quality and Instrumentation time in Primary Maxillary Central Incisor Teeth: A Single blinded Randomized Clinical Trial of Two Rotary File Systems and Manual Instrumentation Based on the KEDOO Classification
Saveetha Dental College and Hospital1 site in 1 country84 target enrollmentStarted: June 28, 2024Last updated:
Trial Snapshot
- Phase
- Phase 2/3
- Status
- Recruiting
- Sponsor
- Enrollment
- 84
- Locations
- 1
- Primary Endpoint
- Quality of obturation using intraoral periapical radiograph- will be assessed as immediate post operative
Study Overview
Brief Summary
Pulpectomy can be done with manual or rotary, single or sequential file systems. Newer specialised pediatric rotary files enables for improvised pulpectomy procedure which can evaluated by obturation quality
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Masking
- Outcome Assessor Blinded
Eligibility Criteria
- Ages
- 3.00 Year(s) to 7.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •Inclusion criteria considered factors such as root length, coronal structure, resorption, and systemic health, with exclusion criteria addressing cooperation ability and underlying systemic diseases.
- •Vital or non-vital primary maxillary central incisors without a sinus tract, absence of pathologic root resorption, nighttime pain, and sufficient coronal tooth structure were essential for inclusion.
Exclusion Criteria
- •uncooperative child child with any systemic illness.
Outcomes
Primary Outcomes
Quality of obturation using intraoral periapical radiograph- will be assessed as immediate post operative
Time Frame: immediate postoperative radiograph taken post pulpectomy
Secondary Outcomes
- Instrumentation time(immediate postoperative)
Investigators
Dr Balaji S
Saveetha Dental College and Hospital
Study Sites (1)
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