Ignite Creation Date:
2024-05-19 @ 5:34 PM
Last Modification Date:
2024-10-26 @ 3:29 PM
Study NCT ID:
NCT06418386
Status:
COMPLETED
Last Update Posted:
2024-05-29
First Post:
2024-05-13
Brief Title:
Bacterial Reduction of Rotary Versus Manual Filing System Using Different Irrigants in Primary Molars
Sponsor:
Mansoura University
Organization:
Mansoura University
Study Overview
Official Title:
Clinical Assessment of Antimicrobial Effect of Rotary Versus Manual Filing System Using Different Irrigants in Primary Molars
Status:
COMPLETED
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 materialMetapexthen 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 1920
2 Identification of bacteria by culture characteristics microscopic examination and biochemical reaction 21
3 Number of colony forming unit will be counted CFUml
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 materialMetapexthen 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 1920
2 Identification of bacteria by culture characteristics microscopic examination and biochemical reaction 21
3 Number of colony forming unit will be counted CFUml
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None