An interventional study of Pediatric rotary files and Manual flare files in Instrumentation Time, sponsored by Cairo University. Status unknown. Open to participants aged 4 Years to 6 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-12-27.
Sponsored by Cairo University · Not applicable, Interventional, and Treatment
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:
Cairo University is the lead sponsor of 4,780 studies on the registry; 1,427 are open to participants now.
Of its 36 completed or terminated interventional studies of FDA-regulated products, 5 (14%) have results posted.
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Children:
Teeth:
Exclusion Criteria:
Children:
Teeth:
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.
Procedure: Pediatric rotary files
Biomechanical preparation will be done using manual flare files (Mani) No. 15-35.
Procedure: Manual flare files
Mechanical preparation of primary tooth canals with pediatric rotary files
Mechanical preparation of primary tooth canals with manual flare files
Instrumentation time
Continuous outcome measured by digital stopwatch in minutes
Time frame: during procedure
Child's behaviour
Using modified frankel scale from 1-5, where scale 1 has the worse behavior and scale 5 has the best behavior
Time frame: during procedure
Postoperative pain
Binary outcome reported by telephone call to the parents
Time frame: 7 days
Tenderness to percussion
Binary outcome measured by percussion test using back of the dental mirror
Time frame: 1 year
Pain on biting
Binary outcome reported by the patient at biting
Time frame: 1 year
Swelling/ fistula / sinus tract
Binary outcome measured with visual examination of the patient
Time frame: 1 year
Mobility
Binary outcome measured by mobility test using back of the two dental mirrors
Time frame: 1 year
Internal or external root resorption
Binary outcome using digital radiograph
Time frame: 1 year
Furcation involvement or periapical radiolucency
Binary outcome using digital radiograph
Time frame: 1 year
No study locations are listed for this record.
Plan to share: No — Data may be provided upon request
No publications or documents are linked to this record.
This study is status unknown, as verified in Dec 2022. You cannot join it, but the record below documents what was studied.
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Cairo University