Clinical and Radiographic Evaluation of Single Visit Pulpectomy in Primary Molars for (5-7) Years Old Children Using Rotary and Manual Instrumentation: A Randomized Clinical Trial
Overview
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Anfal mohamed elmotaz almogtaba
- Enrollment
- 44
- Locations
- 1
- Primary Endpoint
- Clinical success of Pulpectomy procedure
Overview
Brief Summary
This study will evaluate the clinical and radiographic outcomes of rotary versus manual pulpectomy in children with irreversible pulpitis.A single-visit pulpectomy will be performed for all patients. Participants will be allocated to rotary instrumentation using Fanta AF Baby files or manual step-back instrumentation with K-files. Canals will be irrigated with 17% EDTA and 1% sodium hypochlorite, obturated with Metapex, and restored with glass ionomer cement and stainless-steel crowns. Primary outcomes will assess clinical success at 3, 6, 9, and 12 months, while secondary outcomes will evaluate postoperative pain and radiographic success at 6 and 12 months.
Detailed Description
In this study, the principal investigator will screen participants to ensure eligibility and obtain comprehensive medical and dental histories from their parents or legal guardians, along with informed consent. All participants will undergo thorough clinical and radiographic examinations to confirm a diagnosis of irreversible pulpitis and suitability for pulpectomy. Local anesthesia will be administered, followed by caries removal, access cavity preparation, and pulpal extirpation. Working length will be determined radiographically, and participants will be allocated into two groups based on instrumentation technique: Group 1 will receive rotary instrumentation using Fanta AF Baby files with a crown-down approach, while Group 2 will undergo manual instrumentation using K-files with a step-back technique. Irrigation will involve 17% EDTA gel and 1% sodium hypochlorite, and canals will be obturated with Metapex, followed by restoration with glass ionomer cement and stainless-steel crowns in the same visit. The primary outcome will assess clinical success at 3, 6, 9, and 12 months post-treatment, defined by the absence of soft tissue swelling, tenderness, sinus tract, fistula, or pathological mobility. Secondary outcomes will include evaluation of postoperative pain intensity using a modified Wong-Baker Pain Rating Scale and radiographic success at 6 and 12 months, defined by the absence of root resorption, periodontal ligament widening, or periapical/furcal radiolucency.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Care Provider, Outcomes Assessor)
Masking Description
The co-supervisor and main supervisor will also be masked.
Eligibility Criteria
- Ages
- 5 Years to 7 Years (Child)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Children aged 5-7 years with irreversible pulpitis of primary molars.
- •History of spontaneous pain with a deep carious lesion.
- •Parents who approve to write informed consent.
Exclusion Criteria
- •Medically compromised children.
- •Children with a history of allergic reaction to the materials used in the study.
- •Children with non-restorable teeth.
- •Teeth with resorbed roots (more than two-thirds of root length).
- •Extensive internal or external root resorption visible in periapical Radiographs.
Arms & Interventions
Group2: Single-visit pulpectomy using manual instrumentation
This group will include patients with irreversible pulpitis who will undergo single-visit pulpectomy using manual instrumentation
Intervention: Manual Instrumentation (Procedure)
Group 1: Single-Visit Pulpectomy using Rotary instrumentation
This group will include patients with irreversible pulpitis who will undergo single-visit pulpectomy using rotary instrumentation
Intervention: Rotary Instrumentation (Procedure)
Outcomes
Primary Outcomes
Clinical success of Pulpectomy procedure
Time Frame: 12 months
The primary outcome of this study will be the assessment of clinical success of the both instrumentation techniques (Manual and Rotary instrumentation), evaluated at 3, 6, 9, and 12 months post-treatment. Clinical success will be defined based on binary assessment by the absence of soft tissue swelling, tenderness to percussion (Performed by the back of the mirror), sinus tract, fistula, and pathologic mobility
Secondary Outcomes
- Evaluation of Radiographic Success of Pulpectomy(12 months)
Investigators
Anfal mohamed elmotaz almogtaba
Master's student
Cairo University