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The goal of this clinical trial is to evaluate and compare the efficacy of Kedo-Nano Plus rotary files, Kedo-S Square rotary files, and manual K-files for biomechanical preparation during pulpectomy of primary mandibular molars in children aged 5-8 years.
The main questions it aims to answer are:
Researchers will compare Kedo-Nano Plus rotary files, Kedo-S Square rotary files, and manual K-files to determine their effect on obturation quality and postoperative pain.
Participants will:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Manual K-file group | Experimental | Primary mandibular pulpectomy done by manual K- files |
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| Kedo-S Square rotary file group | Experimental | Primary mandibular pulpectomy done by Kedo-S Square rotary file |
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| Kedo-Nano Plus rotary file group | Experimental | Primary mandibular pulpectomy done by Kedo-Nano Plus rotary file |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pulpectomy | Procedure | Pulpectomy is performed in primary mandibular molars requiring endodontic treatment. Following administration of local anesthesia and rubber dam isolation, an access cavity is prepared and the root canals are identified. Working length is determined, followed by biomechanical preparation and irrigation of the root canals. The canals are then dried and obturated with a resorbable root canal filling material. The tooth is subsequently restored with an appropriate coronal restoration. Postoperative pain is assessed at predetermined intervals following treatment, and radiographic evaluation is performed to assess the quality of obturation. |
| Measure | Description | Time Frame |
|---|---|---|
| To assess the quality of obturation between Kedo- Nano Plus, Kedo- S Square pediatric rotary single file systems and manual K files after pulpectomy in primary mandibular molars | Quality of obturation will be assessed radiographically following pulpectomy in primary mandibular molars. The obturation will be categorized as optimal fill, underfill, or overfill based on the extent of obturation material in relation to the radiographic apex. The outcome measure will be used to compare the effectiveness of the instrumentation techniques in achieving adequate root canal filling. | At the end of the pulpectomy procedure, immediately following obturation. |
| Measure | Description | Time Frame |
|---|---|---|
| To evaluate the intensity of post-operative pain following pulpectomy performed using Kedo- Nano Plus, Kedo- S Square pediatric rotary single file systems and manual K files at the interval of 6,12,24 and 48 hours postoperatively. | Postoperative pain will be assessed following pulpectomy in primary mandibular molars using the Wong-Baker Faces Pain Rating Scale. Pain intensity will be recorded at 6, 12, 24, and 48 hours after completion of the procedure. The outcome measure will be used to compare the level and progression of postoperative pain among the study groups over time. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Paul Chalakkal, MDS | Goa Dental College and Hospital | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Goa Dental College and Hospital | Bambolim | Goa | 403202 | India |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Oct 19, 2024 | Jul 10, 2026 |
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| Kedo-S Square rotary file | Device | Kedo S Square pediatric rotary file system was used for biomechanical preparation/root canal instrumentation of primary teeth as per the study protocol. |
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| Manual K files | Device | Manual K files were used for biomechanical preparation/root canal instrumentation of primary teeth as per the study protocol. |
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| Kedo-Nano Plus rotary file | Device | Kedo Nano Plus pediatric rotary file system was used for biomechanical preparation/root canal instrumentation of primary teeth as per the study protocol. |
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| From completion of the pulpectomy procedure to 48 hours postoperatively, with assessments at 6, 12, 24, and 48 hours. |
| Prot_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Oct 19, 2024 | Jul 10, 2026 | ICF_001.pdf |
| ID | Term |
|---|---|
| D011670 | Pulpectomy |
| ID | Term |
|---|---|
| D004708 | Endodontics |
| D003813 | Dentistry |
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