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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?
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group I pulpectomy using single rotary file system | Experimental | Administration of local anesthesia at the side of the affected tooth. Application of the rubber dam for isolation, then a standardized pulpectomy procedure will be performed using a large sterile round end bur in a high-speed hand piece with copious irrigation. After opening the access cavity, the root canal patency was checked for all the canals located using a size #10 (0.02%) k-file then a single rotary file (20 taper 4) will be adjusted on the desirable working length depending on an electronic apex locator (1 mm shorter than the apex) and used in pulpectomy in a brushing motion at the rotational speed 300 rpm with torque set at the lowest level, irrigation with saline |
|
| Group II pulpectomy using manual files system | Active Comparator | Administration of local anesthesia at the side of the affected tooth. Application of the rubber dam for isolation, then a standardized pulpectomy procedure will be performed using a large sterile round end bur in a high-speed hand piece with copious irrigation. After opening the access cavity, manual files (k files, Mani, Inc., Japan) size 15,20,25,30 will be adjusted on the desirable working length depending on an electronic apex locator (1 mm shorter than the apex) and used in pulpectomy in a brushing motion, irrigation with saline |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fanta AF F one rotary files 20 taper 4 | Device | Fanta AF F one rotary files 20 taper 4 single rotary file system |
|
| Measure | Description | Time Frame |
|---|---|---|
| Post-operative pain | : 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.
| At 6, 12, 24, 48 and 72 hours and 1 week after Treatment |
| Measure | Description | Time Frame |
|---|---|---|
| child's behavior level | 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 |
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Inclusion Criteria:
• Patients:
Pre-operative Radiographic criteria:
Exclusion Criteria:
• Patients:
Teeth:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Mona A amer, Master | Contact | +201100877939 | mona.amen@dentistry.cu.edu.eg | |
| Hanaa A Abd El Moniem, Phd | Contact | hanaa.ibraheem@dentistry.cu.edu.eg |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Faculty of Dentistry, Cairo University | Cairo | Egypt | 11411 | Egypt |
data is available with the corresponding author on reasonable request
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The blinding of operator is not possible due to the nature of the technique used
| Manual files (k files ,Mani, Inc., Japan). | Device | manual files (k files, Mani, Inc., Japan) size 15,20,25,30 |
|
| (Immediately after treatment) |
| Clinical Success |
| ( At 3, 6, 12 months) |
| Instrumentation time | will be recorded using a stopwatch | (During procedure start from anathesia till end of procedure) |
| The obturation quality | will be assessed using a radiograph(Using Coll and Sadrian criteria) | (Immediately after treatment) |