Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Cairo University | OTHER |
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rotary Instrumentation | Procedure | Single visit pulpectomy using rotary instrumentation |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Anfal Mohammed Almogtaba, Bechlor's degree in dentistry | Contact | +201125202599 | anfal.mohamed@dentistry.cu.edu.eg |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cairo University | Cairo | Cairo Governorate | 11835 | Egypt |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D010146 | Pain |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
The study will include two groups with an allocation ratio of 1:1.
Not provided
Not provided
The co-supervisor and main supervisor will also be masked.
| Manual Instrumentation | Procedure | Single visit pulpectomy using manual instrumentation |
|
| 12 months |