Bacterial Reduction of Rotary Versus Manual Filing System Using Different Irrigants in Primary Molars
NCT ID: NCT06418386
Last Updated: 2024-05-29
Study Results
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Basic Information
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COMPLETED
NA
30 participants
INTERVENTIONAL
2022-09-12
2024-05-12
Brief Summary
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Detailed Description
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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 :
1. Psychological management of child
2. X-ray for inclusion criteria
3. The procedural tooth is anesthetized and isolated with rubber dam. The tooth and adjacent rubber dam will be disinfected with tincture of iodine solution
4. . All carious tissue will be removed by sterilized round bur and root canal access will be done
5. On gaining the access, distal cannel of mandibular primary molars and palatal cannel of maxillary primary molars will be chosen for sampling procedure.
6. A sterile broach will be inserted to obtain root cannel content then sterile paper point inserted to root canal and will be left for 1 min 19 The paper point will be removed with sterilized tweezer which will immediately transferred to tube containing transport medium (eppendrof of containing 200 μl nutrient broth medium).
7. In-group 1 will be prepared with manual files the irrigation with saline in IA, with neem in IB and irrigation with NaOCl in IC.
8. In group II will be prepared with rotary files the irrigation with saline in IIA, with neem in IIB, with NaOCl in IIC
9. The sterile paper point will be introduced into root cannel and will be left for 1 min, the paper point will be removed with sterilized tweezer and then transferred to a tube containing transport medium 19.
10. Post irrigation sample and pre-preparation sample will be transferred to microbiological laboratory.
11. Canals will be filed with obturation material(Metapex)then crown will be restored with glass inomar and stainless steel crown
Laboratory procedures :
1. All samples will be incubated on blood agar aerobically and anaerobically at 37 for 48-72 hours and aspectically streak the plates 19,20.
2. Identification of bacteria by culture characteristics ,microscopic examination and biochemical reaction 21.
3. Number of colony forming unit will be counted (CFU/ml)
Conditions
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Study Design
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RANDOMIZED
PARALLEL
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
TREATMENT
SINGLE
Study Groups
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manual saline
manual k files for pulpectomy and normal saline irrigation
manual saline IA
* The procedural tooth is anesthetized and isolated with rubber dam. The tooth and adjacent rubber dam will be disinfected with tincture of iodine solution, All carious tissue will be removed by hight speed handpiece, distal cannel of mandibular primary molars and palatal cannel of maxillary primary molars will be chosen for sampling procedure.
* A sterile broach will be inserted to obtain root cannel content then sterile paper point inserted to root canal and will be left for 1 min ,The paper point will be removed with sterilized tweezer which will immediately transferred to tube containing transport medium (eppendrof of containing 200 μl nutrient broth medium),using manual k file starting with #15 and irrigation with normal saline
* Post irrigation sample and pre-preparation sample will be transferred to microbiological laboratory Canals will be filed with obturation material(Metapex)then crown will be restored with glass inomar and stainless steel crown
manual neem extract
manual k files and 100% neem extract
manual neem IB
* The procedural tooth is anesthetized and isolated with rubber dam. The tooth and adjacent rubber dam will be disinfected with tincture of iodine solution
* . All carious tissue will be removed by high speed hand piece
, distal cannel of mandibular primary molars and palatal cannel of maxillary primary molars will be chosen for sampling procedure.
* A sterile broach will be inserted to obtain root cannel content then sterile paper point inserted to root canal and will be left for 1 min 19 The paper point will be removed with sterilized tweezer which will immediately transferred to tube containing transport medium (eppendrof of containing 200 μl nutrient broth medium).
* using manual file and irrigation with neem leaf extract 100%
* Post irrigation sample and pre-preparation sample will be transferred to microbiological laboratory Canals will be filed with obturation material(Metapex)then crown will be restored with glass inomar and stainless steel crown
manual sodium hypochlorite
mannul k files and 1% sodium hypochlorite
manual sodium hypochlorite IC
* adjacent rubber dam will be disinfected with tincture of iodine solution
* . All carious tissue will be removed by hight speed hand piece
* distal cannel of mandibular primary molars and palatal cannel of maxillary primary molars will be chosen for sampling procedure.
* A sterile broach will be inserted to obtain root cannel content then sterile paper point inserted to root canal and will be left for 1 min 19 The paper point will be removed with sterilized tweezer which will immediately transferred to tube containing transport medium (eppendrof of containing 200 μl nutrient broth medium).
* using manual file and irrigation with 1% sodium hypochlorite
* Post irrigation sample and pre-preparation sample will be transferred to microbiological laboratory Canals will be filed with obturation material(Metapex)then crown will be restored with glass inomar and stainless steel crown
rotary saline
AF baby files for pediatric( fanta ) and normal saline
rotary saline IIA
* shaping and cleaning done with using AF baby fanta files open file:#17 taper 08,then #20 taper 04 ,yellow then #25 taper 04 red , then #30 taper 04 blue . the files activated with torque 2 and speed 350 . Irrigation with normal saline
* Post irrigation sample and pre-preparation sample will be transferred to microbiological laboratory Canals will be filed with obturation material(Metapex)then restored with glass inomar and stainless steel crown
rotary neem
AF baby files for pediatric( fanta ) and 100% NEEM EXTRACT
rotary neem IIB
* The procedural tooth is anesthetized and isolated with rubber dam as mentioned
* All carious tissue will be removed by high speed hand piece ,distal cannel of mandibular primary molars and palatal cannel of maxillary primary molars will be chosen for sampling procedure.
* A sterile broach will be inserted to obtain root cannel content then sterile paper point inserted to root canal and will be left for 1 min The paper point will be removed with sterilized tweezer which will immediately transferred to tube containing transport medium (eppendrof of containing 200 μl nutrient broth medium).
* using AF baby fanta files SAME AS METION BEFORE ,and irrigation with 100%neem extract
* Post irrigation sample and pre-preparation sample will be transferred to microbiological laboratory Canals will be filed with obturation material(Metapex)then crown will be restored with glass inomar and stainless steel crown
rotary sodium hypochloride
AF baby files for pediatric( fanta ) and 1% sodium hypochloride
rotary sodoium hypochlorite IIC
* The procedural tooth is anesthetized and isolated with rubber dam as mentioned
* All carious tissue will be removed by hight speed hand piece,distal cannel of mandibular primary molars and palatal cannel of maxillary primary molars will be chosen for sampling procedure.
* A sterile broach will be inserted to obtain root cannel content then sterile paper point inserted to root canal and will be left for 1 min The paper point will be removed with sterilized tweezer which will immediately transferred to tube containing transport medium (eppendrof of containing 200 μl nutrient broth medium).
* using AF baby fanta files SAME AS MENTION BEFORE , and irrigation with 1% sodium hypochlorite
* Post irrigation sample and pre-preparation sample will be transferred to microbiological laboratory Canals will be filed with obturation material(Metapex)then crown will be restored with glass inomar and stainless steel crown
Interventions
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manual saline IA
* The procedural tooth is anesthetized and isolated with rubber dam. The tooth and adjacent rubber dam will be disinfected with tincture of iodine solution, All carious tissue will be removed by hight speed handpiece, distal cannel of mandibular primary molars and palatal cannel of maxillary primary molars will be chosen for sampling procedure.
* A sterile broach will be inserted to obtain root cannel content then sterile paper point inserted to root canal and will be left for 1 min ,The paper point will be removed with sterilized tweezer which will immediately transferred to tube containing transport medium (eppendrof of containing 200 μl nutrient broth medium),using manual k file starting with #15 and irrigation with normal saline
* Post irrigation sample and pre-preparation sample will be transferred to microbiological laboratory Canals will be filed with obturation material(Metapex)then crown will be restored with glass inomar and stainless steel crown
manual neem IB
* The procedural tooth is anesthetized and isolated with rubber dam. The tooth and adjacent rubber dam will be disinfected with tincture of iodine solution
* . All carious tissue will be removed by high speed hand piece
, distal cannel of mandibular primary molars and palatal cannel of maxillary primary molars will be chosen for sampling procedure.
* A sterile broach will be inserted to obtain root cannel content then sterile paper point inserted to root canal and will be left for 1 min 19 The paper point will be removed with sterilized tweezer which will immediately transferred to tube containing transport medium (eppendrof of containing 200 μl nutrient broth medium).
* using manual file and irrigation with neem leaf extract 100%
* Post irrigation sample and pre-preparation sample will be transferred to microbiological laboratory Canals will be filed with obturation material(Metapex)then crown will be restored with glass inomar and stainless steel crown
manual sodium hypochlorite IC
* adjacent rubber dam will be disinfected with tincture of iodine solution
* . All carious tissue will be removed by hight speed hand piece
* distal cannel of mandibular primary molars and palatal cannel of maxillary primary molars will be chosen for sampling procedure.
* A sterile broach will be inserted to obtain root cannel content then sterile paper point inserted to root canal and will be left for 1 min 19 The paper point will be removed with sterilized tweezer which will immediately transferred to tube containing transport medium (eppendrof of containing 200 μl nutrient broth medium).
* using manual file and irrigation with 1% sodium hypochlorite
* Post irrigation sample and pre-preparation sample will be transferred to microbiological laboratory Canals will be filed with obturation material(Metapex)then crown will be restored with glass inomar and stainless steel crown
rotary saline IIA
* shaping and cleaning done with using AF baby fanta files open file:#17 taper 08,then #20 taper 04 ,yellow then #25 taper 04 red , then #30 taper 04 blue . the files activated with torque 2 and speed 350 . Irrigation with normal saline
* Post irrigation sample and pre-preparation sample will be transferred to microbiological laboratory Canals will be filed with obturation material(Metapex)then restored with glass inomar and stainless steel crown
rotary neem IIB
* The procedural tooth is anesthetized and isolated with rubber dam as mentioned
* All carious tissue will be removed by high speed hand piece ,distal cannel of mandibular primary molars and palatal cannel of maxillary primary molars will be chosen for sampling procedure.
* A sterile broach will be inserted to obtain root cannel content then sterile paper point inserted to root canal and will be left for 1 min The paper point will be removed with sterilized tweezer which will immediately transferred to tube containing transport medium (eppendrof of containing 200 μl nutrient broth medium).
* using AF baby fanta files SAME AS METION BEFORE ,and irrigation with 100%neem extract
* Post irrigation sample and pre-preparation sample will be transferred to microbiological laboratory Canals will be filed with obturation material(Metapex)then crown will be restored with glass inomar and stainless steel crown
rotary sodoium hypochlorite IIC
* The procedural tooth is anesthetized and isolated with rubber dam as mentioned
* All carious tissue will be removed by hight speed hand piece,distal cannel of mandibular primary molars and palatal cannel of maxillary primary molars will be chosen for sampling procedure.
* A sterile broach will be inserted to obtain root cannel content then sterile paper point inserted to root canal and will be left for 1 min The paper point will be removed with sterilized tweezer which will immediately transferred to tube containing transport medium (eppendrof of containing 200 μl nutrient broth medium).
* using AF baby fanta files SAME AS MENTION BEFORE , and irrigation with 1% sodium hypochlorite
* Post irrigation sample and pre-preparation sample will be transferred to microbiological laboratory Canals will be filed with obturation material(Metapex)then crown will be restored with glass inomar and stainless steel crown
Eligibility Criteria
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Inclusion Criteria
* good health.
* No recent history of antibiotic coverage for at least two weeks
* necrotic teeth.
* restorable tooth structure.
Exclusion Criteria
* uncooperative patient.
* detection perforation on radiograph.
4 Years
8 Years
ALL
Yes
Sponsors
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Mansoura University
OTHER
Responsible Party
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Menna Mahgoub
principle investigator
Principal Investigators
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mansoura university
Role: STUDY_CHAIR
Mansoura University
Locations
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Mansoura University
Al Mansurah, , Egypt
Countries
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References
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Susila AV, Sai S, Sharma N, Balasubramaniam A, Veronica AK, Nivedhitha S. Can natural irrigants replace sodium hypochlorite? A systematic review. Clin Oral Investig. 2023 May;27(5):1831-1849. doi: 10.1007/s00784-023-04913-7. Epub 2023 Feb 18.
Sundaram D, Narayanan RK, Vadakkepurayil K. A Comparative Evaluation on Antimicrobial Effect of Honey, Neem Leaf Extract and Sodium Hypochlorite as Intracanal Irrigant: An Ex-Vivo Study. J Clin Diagn Res. 2016 Aug;10(8):ZC88-91. doi: 10.7860/JCDR/2016/19268.8311. Epub 2016 Aug 1.
Lakshmanan L, Jeevanandan G. Microbial Evaluation of Root Canals after Biomechanical Preparation with Manual K-files, Manual H-files, and Kedo-SG Blue Rotary Files: An In Vivo Study. Int J Clin Pediatr Dent. 2022 Nov-Dec;15(6):687-690. doi: 10.5005/jp-journals-10005-2457.
Other Identifiers
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M18060722
Identifier Type: -
Identifier Source: org_study_id
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