Clinical Assessment of Antimicrobial Effect of Rotary Versus Manual Filing System Using Different Irrigants in Primary Molars
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Mansoura University
- Enrollment
- 30
- Locations
- 1
- Primary Endpoint
- number of of colony forming units
Study Overview
Brief Summary
This study will evaluate and compare the microbial efficacy of rotary and manual filing system using Neem extract, NaOCL and saline . with hypotheses that neem can used alternative to sodium hypochlorite and there is no difference between rotary and manual filling in bacterial reduction.
Detailed Description
The calculated sample size of the study will be 22 participants for each group at 5% level of significance and 80 % power 30 participants for each group (10 for The sample size will be increased tocompensate for incomplete data and to increase the study each subgroup) topower
Grouping:
30 child will be selected from the Pediatric Clinic, Faculty of Dentistry, Mansoura University .the child should have 2 contralateral primary molars indicated for pulpectomy. The children will be randomly divided into 2 main groups according to type of file used in root canal preparation: Group I with manual file. Group II with rotary file.
Then the children will be randomly sub grouped according to irrigant that will be used:
Group IA and group II A with normal saline. Group IB and group II B with neem . Group IC and group II C with NaOCl . clinical procedures :
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 4 Years to 8 Years (Child)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •age group 4 -8 years.
- •good health.
- •No recent history of antibiotic coverage for at least two weeks
- •necrotic teeth.
- •restorable tooth structure.
Exclusion Criteria
- •more than 2/3 resorption of root.
- •uncooperative patient.
- •detection perforation on radiograph.
Arms & Interventions
rotary saline
AF baby files for pediatric( fanta ) and normal saline
Intervention: rotary saline IIA (Procedure)
manual saline
manual k files for pulpectomy and normal saline irrigation
Intervention: manual saline IA (Procedure)
manual neem extract
manual k files and 100% neem extract
Intervention: manual neem IB (Procedure)
manual sodium hypochlorite
mannul k files and 1% sodium hypochlorite
Intervention: manual sodium hypochlorite IC (Procedure)
rotary neem
AF baby files for pediatric( fanta ) and 100% NEEM EXTRACT
Intervention: rotary neem IIB (Procedure)
rotary sodium hypochloride
AF baby files for pediatric( fanta ) and 1% sodium hypochloride
Intervention: rotary sodoium hypochlorite IIC (Procedure)
Outcomes
Primary Outcomes
number of of colony forming units
Time Frame: 48 hours after culture
number of of colony forming units less the better instrumentation technique and irritant
Secondary Outcomes
No secondary outcomes reported
Investigators
Menna Mahgoub
principle investigator
Mansoura University