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Clinical Trials/NCT07319741
NCT07319741
Not yet recruiting
Not Applicable

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

Anfal mohamed elmotaz almogtaba1 site in 1 country44 target enrollmentStarted: February 1, 2026Last updated:

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

Active Comparator

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

Active Comparator

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

Sponsor
Anfal mohamed elmotaz almogtaba
Sponsor Class
Other
Responsible Party
Sponsor Investigator
Principal Investigator

Anfal mohamed elmotaz almogtaba

Master's student

Cairo University

Study Sites (1)

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