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Clinical and Radiographic Outcomes of Rotary Instrumentation in Primary Molars

ConditionsPulpectomyIrreversible Pulpitis
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age5-7
SponsorAnfal mohamed elmotaz almogtaba

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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).

Trial design

Design model

Parallel

Treatments tested in this trial

  • Rotary Instrumentation

    Procedure/Surgery

    Single visit pulpectomy using rotary instrumentation

  • Manual Instrumentation

    Procedure/Surgery

    Single visit pulpectomy using manual instrumentation

Treatment groups

44 Participants
are divided into 2 treatment groups
Group A: Group 1: Single-Visit Pulpectomy using Rotary instrumentationActive comparator 1 intervention
Group B: Group2: Single-visit pulpectomy using manual instrumentationActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Clinical success of Pulpectomy procedure

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

Time frame
12 months

Secondary outcomes

1

Evaluation of Radiographic Success of Pulpectomy

Another secondary outcome of this study will be the radiographic evaluation of treatment after manual and rotary instrumentation based on binary assessment at 6 and 12 months postoperatively. Radiographic success will be defined as the absence of internal or external root resorption, loss of lamina dura integrity, periodontal ligament widening, or alveolar bone resorption in the periapical region. The presence of any of these findings or periapical/furcal radiolucency will be considered radiographic failure. 13\. Participant Timeline

Time frame
12 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Anfal mohamed elmotaz almogtaba

Lead sponsor

Cairo University

Sponsor institution

Cairo University

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: