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The study will be conducted to evaluate instrumentation time, obturation quality, and child's behavior using pediatric rotary versus hand flare file systems in treatment of primary molars.
Statement of the problem:
Pulpally affected primary teeth is a common problem in children due to lower mineralization, the presence of large pulp chamber with high pulp horns, and thin layers of enamel and dentin .
Manual files system is usually used for management of pulpally affected primary molars. This system has shown through the past years an acceptable clinical success rate but it also have many problems such as long visit time affecting the child behavior and causing fatigue to the dentist, difficulty in dealing with thin and curved canals due to limited flexibility of manual files causing incomplete removal of pulp tissue, and also difficulty in the determination of the actual working length due to the presence of physiologic and pathologic root resorption.
Rationale for conducting the research:
Pulp therapy in primary molars becomes compromised sometimes after delayed treatment due to dental neglect of children till caries progression to the pulp leading to severe symptoms associated with excessive pulp inflammation, root resorption, or periradicular bone resorption with a less favorable prognosis for conventional endodontic therapy. In the current era, a new perspective which is less time consuming with an acceptable success rate could be a spark of hope for the pediatric patient as well as the dentists.
Many studies were done comparing manual vs pediatric rotary files but without definitive conclusion. So further studies should be done with higher sample size to determine the superiority of one system over the other.
Benefits for the practitioner:
Benefits for the patient:
Benefits for community:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pediatric rotary files | Experimental | Biomechanical preparation will be done using pediatric rotary file system (Kedo-SG blue file system). D1 and E1 files will be used at 300 rpm and 2.4 N/cm torque. |
|
| Manual flare files | Active Comparator | Biomechanical preparation will be done using manual flare files (Mani) No. 15-35. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pediatric rotary files | Procedure | Mechanical preparation of primary tooth canals with pediatric rotary files |
|
| Measure | Description | Time Frame |
|---|---|---|
| Instrumentation time | Continuous outcome measured by digital stopwatch in minutes | during procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Child's behaviour | Using modified frankel scale from 1-5, where scale 1 has the worse behavior and scale 5 has the best behavior | during procedure |
| Postoperative pain | Binary outcome reported by telephone call to the parents |
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Inclusion Criteria:
Children:
Teeth:
Exclusion Criteria:
Children:
Teeth:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ahmed W Ismael, Master | Contact | +21114036028 | ahmed.ismael@dentistry.cu.edu.eg |
| Name | Affiliation | Role |
|---|---|---|
| Manal A Elsayed, Professor | Cairo University | Study Director |
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Data may be provided upon request
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Split mouth RCT
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| Manual flare files | Procedure | Mechanical preparation of primary tooth canals with manual flare files |
|
| 7 days |
| Tenderness to percussion | Binary outcome measured by percussion test using back of the dental mirror | 1 year |
| Pain on biting | Binary outcome reported by the patient at biting | 1 year |
| Swelling/ fistula / sinus tract | Binary outcome measured with visual examination of the patient | 1 year |
| Mobility | Binary outcome measured by mobility test using back of the two dental mirrors | 1 year |
| Internal or external root resorption | Binary outcome using digital radiograph | 1 year |
| Furcation involvement or periapical radiolucency | Binary outcome using digital radiograph | 1 year |