Irreversible Pulpitis
Conditions
Keywords
single rotary file, pulpectomy, primary molars, manual instrumentation
Brief summary
To compare the post operative pain in pulpectomy of primary molars using a single rotary file system versus conventional manual instrumentation, through a Randomized Clinical Trial. The main question it aims to answer is: Is there a difference in post operative pain when using single rotary file system versus manual instrumentation in pulpectomy of primary molars?
Detailed description
Endodontic procedures remain among the most commonly performed treatments following the diagnosis of pulpal inflammation or pathology. However, in primary teeth, endodontic treatment poses substantial difficulties owing to its complex anatomy and canal systems * Maintaining a primary tooth after successful root canal treatment is highly beneficial, as the preserved tooth serves as the most effective natural spacemaintainer * In cases of irreversible pulpitis, endodontic therapy remains the most common and frequently performed procedure to alleviate pain * Pulpectomy in primary molars is a critical treatment modality in pediatric dentistry when the pulp is irreversibly inflamed. Traditional instrumentation for pulpectomy often relies on manual files (e.g., stainless steel K-files), which can be time-consuming, technique sensitive, and may pose challenges due to the complex and delicate root anatomy of primary teeth * Rotary nickel-titanium (NiTi) systems have potential advantages: more efficient preparation, reduced chair-time, and possibly better patient cooperation. Indeed, study has found that rotary instrumentation significantly reduces both the instrumentation and obturation time and is associated with lower postoperative pain * Postoperative pain is one way to measure the success of endodontic treatment
Interventions
Fanta AF F one rotary files 20 taper 4 single rotary file system
manual files (k files, Mani, Inc., Japan) size 15,20,25,30
Sponsors
Cairo University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Masking description
The blinding of operator is not possible due to the nature of the technique used
Eligibility
Sex/Gender
ALL
Age
4 Years to 6 Years
Healthy volunteers
Yes
Inclusion criteria
* • Patients: * Aged 4-6years, Medically free and Cooperative. * Teeth: * Restorable mandibular second primary molars with clinical signs or symptoms of irreversible pulpitis. Pre-operative Radiographic criteria: * Absence of internal or external root resorption. * Absence of periapical or inter-radicular radiolucencies.
Exclusion criteria
* • Patients: * Uncooperative children. * Children with systemic disease. * Physical or mental disabilities. * Refusal of participation. * Unable to attend follow- up visits. * Refusal to sign the informed consent. Teeth: * Previously accessed teeth. * Mobile mandibular primary molars. * Pain on percussion. * Swelling in the vestibule or on palpation.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Post-operative pain | At 6, 12, 24, 48 and 72 hours and 1 week after Treatment | : will be recorded by Asking the patient and/or guardian using a 4-point pain scale at 6, 12, 24, 48 and 72 hours And 1 week after treatment. The parent of each participant will receive 6 flashcards that include four faces and a word describing each face. 0 - None: No pain present. 1. \- Mild: Pain is present but not distracting; easily ignored. 2. \- Moderate: Pain is distracting; manageable but limits activities. 3. \- Severe: Intense pain; unable to concentrate, requires immediate action or medication |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| child's behavior level | (Immediately after treatment) | child's behavior level: will be recorded by using FRANKEL behavior rating Scale: rate 1 means definitely negative "refusal of treatment , fearfulness" rate 2 means negative "reluctance to accept treatment , uncooperative" rate 3 means positive "acceptance of treatment , patient follows the dentist's directions" rate 4 means definitely positive " good rapport with the dentist , laughter and enjoyment |
| Clinical Success | ( At 3, 6, 12 months) | 1. Absence of swelling will be recorded by visual examination 2. Absence of sinus or fistula: will be recorded by visual examination. 3. Pathologic mobility: will be recorded by mobility test (pressure using the end of two dental mirrors) |
| Instrumentation time | (During procedure start from anathesia till end of procedure) | will be recorded using a stopwatch |
| The obturation quality | (Immediately after treatment) | will be assessed using a radiograph(Using Coll and Sadrian criteria) |
Countries
Egypt
Contacts
CONTACTMona A amer, Master
CONTACTHanaa A Abd El Moniem, Phd
Outcome results
None listed