Mandibular Molar Teeth With Symptomatic Irreversible Pulpitis, Primary Teeth Indicated for Pulp Therapy, Pulpectomy
Conditions
Keywords
Pulpectomy, Primary mandibular molars indicated for pulpectomy, pediatric rotary files
Brief summary
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: * Does the use of Kedo-Nano Plus and Kedo-S Square rotary file systems result in better obturation quality compared with manual K-files during pulpectomy of primary mandibular molars? * Does the use of Kedo-Nano Plus and Kedo-S Square rotary file systems reduce postoperative pain compared with manual K-files following pulpectomy? 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: * Undergo clinical and radiographic evaluation of primary mandibular molars requiring pulpectomy. * Be randomly allocated to one of three instrumentation groups: Kedo-Nano Plus rotary files, Kedo-S Square rotary files, or manual K-files. * Receive pulpectomy treatment using the assigned instrumentation technique. * Undergo radiographic assessment of obturation quality following treatment. * Have postoperative pain assessed using the Wong-Baker Faces Pain Rating Scale at 6, 12, 24, and 48 hours after treatment.
Interventions
PROCEDUREPulpectomy
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.
DEVICEKedo-S Square rotary file
Kedo S Square pediatric rotary file system was used for biomechanical preparation/root canal instrumentation of primary teeth as per the study protocol.
DEVICEManual K files
Manual K files were used for biomechanical preparation/root canal instrumentation of primary teeth as per the study protocol.
DEVICEKedo-Nano Plus rotary file
Kedo Nano Plus pediatric rotary file system was used for biomechanical preparation/root canal instrumentation of primary teeth as per the study protocol.
Sponsors
Goa Dental College
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
5 Years to 8 Years
Healthy volunteers
No
Inclusion criteria
* Normal, healthy children between five and eight years of age * Frankl's behavior rating: positive or definitely positive * Primary mandibular molars diagnosed with irreversible pulpitis * Intact crown structure suitable for rubber dam placement * Intraoral periapical radiograph showing primary molars with at least two-thirds of each root remaining
Exclusion criteria
* Children with special healthcare needs or systemic medical conditions * Frankl's behavior rating: negative or definitely negative * Primary molars with unrestorable crown structure * Teeth with severe mobility or pathological root resorption * Children or parents who refused to participate in the study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 | At the end of the pulpectomy procedure, immediately following obturation. | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. | From completion of the pulpectomy procedure to 48 hours postoperatively, with assessments at 6, 12, 24, and 48 hours. | 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. |
Countries
India
Contacts
STUDY_DIRECTORPaul Chalakkal, MDS
Goa Dental College and Hospital
Outcome results
None listed