Ignite Creation Date:
2024-10-25 @ 7:57 PM
Last Modification Date:
2024-10-26 @ 3:35 PM
Study NCT ID:
NCT06506526
Status:
COMPLETED
Last Update Posted:
None
First Post:
2024-03-16
Brief Title:
Evaluation of Chitosan as Irrigating Solution for Pulpectomy in Non-Vital Primary Teeth
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Clinical Radiographical and Microbiological Evaluation of Chitosan as Irrigating Solution for Pulpectomy in Non-Vital Primary Teeth
Status:
COMPLETED
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
45 teeth will be sub-divided at random with a computerized method according to the type irrigant and duration of its application into 3 groups 15 teeth in each group
Group1control group
The teeth will be irrigated by 2 ml 1 NaOCl after each file
Group2
The teeth will be irrigated by 2 ml 1 NaOCl after each file then with 5 ml of 02 chitosan for one minute
Group 3
The teeth will be irrigated by 2 ml 1 NaOCl after each file then with 5 ml of 02 chitosan for 3 minutes
Evaluation
Clinical evaluation will be done for all groups at one three six and 12 months The following parameters will be evaluated Pain spontaneous pain and pain with percussion Degree of mobility Resolution of signs of infection fistula at the mucobuccal fold
Radiographical evaluation will be performed to each patient immediately after the final restoration and three six and 12 months postoperatively
The decrease of radiolucency and the presence of internal or external root resorption will be evaluated
Bacteriology
The microbiological evaluation will be done at the Biotechnology Research Institute - Suez Canal University
PCR will be used for detection of Enterococcus faecalis Microbiological investigation will be used for counting the number of Enterococcus faecalis
Group1control group
The teeth will be irrigated by 2 ml 1 NaOCl after each file
Group2
The teeth will be irrigated by 2 ml 1 NaOCl after each file then with 5 ml of 02 chitosan for one minute
Group 3
The teeth will be irrigated by 2 ml 1 NaOCl after each file then with 5 ml of 02 chitosan for 3 minutes
Evaluation
Clinical evaluation will be done for all groups at one three six and 12 months The following parameters will be evaluated Pain spontaneous pain and pain with percussion Degree of mobility Resolution of signs of infection fistula at the mucobuccal fold
Radiographical evaluation will be performed to each patient immediately after the final restoration and three six and 12 months postoperatively
The decrease of radiolucency and the presence of internal or external root resorption will be evaluated
Bacteriology
The microbiological evaluation will be done at the Biotechnology Research Institute - Suez Canal University
PCR will be used for detection of Enterococcus faecalis Microbiological investigation will be used for counting the number of Enterococcus faecalis
Detailed Description:
45 teeth will be sub-divided at random with a computerized method according to the type irrigant and duration of its application into 3 groups 15 teeth in each group
Group1control group
The teeth will be irrigated by 2 ml 1 NaOCl after each file
Group2
The teeth will be irrigated by 2 ml 1 NaOCl after each file then with 5 ml of 02 chitosan for one minute
Group 3
The teeth will be irrigated by 2 ml 1 NaOCl after each file then with 5 ml of 02 chitosan for 3 minutes
The root canals will then be flushed with 5 ml saline Second microbiological sample will be collected The tooth will be dried using paper points and then will be temporarily sealed with glass ionomer restoration
Second Visit after two days
Glass ionomer will be removed and the third microbiological sample will be collected
Zinc oxide and eugenol will be used as root canal filling material All cases will be subjected to clinical and radiographical evaluation
Evaluation
Clinical evaluation will be done for all groups at one three six and 12 months The following parameters will be evaluated Pain spontaneous pain and pain with percussion Degree of mobility Resolution of signs of infection fistula at the mucobuccal fold
Radiographical evaluation will be performed to each patient immediately after the final restoration and three six and 12 months postoperatively
The decrease of radiolucency and the presence of internal or external root resorption will be evaluated
Bacteriology
The microbiological evaluation will be done at the Biotechnology Research Institute - Suez Canal University
PCR will be used for detection of Enterococcus faecalis Microbiological investigation will be used for counting the number of Enterococcus faecalis
Microbiological sample collection protocol
Two sterile paper points will be introduced into the canals until they reached the full working length and kept in place for 60 seconds 19 Each paper point will be immediately embedded in 3ml sterile tube containing adequate transporting medium or saline solution
The first tube will be transported to the microbiological laboratory for culturing within a maximum of 2 hours while the other tube will be kept at -80 C for DNA extraction and direct detection of Enterococcus faecalis via multiplex PCR assay
Group1control group
The teeth will be irrigated by 2 ml 1 NaOCl after each file
Group2
The teeth will be irrigated by 2 ml 1 NaOCl after each file then with 5 ml of 02 chitosan for one minute
Group 3
The teeth will be irrigated by 2 ml 1 NaOCl after each file then with 5 ml of 02 chitosan for 3 minutes
The root canals will then be flushed with 5 ml saline Second microbiological sample will be collected The tooth will be dried using paper points and then will be temporarily sealed with glass ionomer restoration
Second Visit after two days
Glass ionomer will be removed and the third microbiological sample will be collected
Zinc oxide and eugenol will be used as root canal filling material All cases will be subjected to clinical and radiographical evaluation
Evaluation
Clinical evaluation will be done for all groups at one three six and 12 months The following parameters will be evaluated Pain spontaneous pain and pain with percussion Degree of mobility Resolution of signs of infection fistula at the mucobuccal fold
Radiographical evaluation will be performed to each patient immediately after the final restoration and three six and 12 months postoperatively
The decrease of radiolucency and the presence of internal or external root resorption will be evaluated
Bacteriology
The microbiological evaluation will be done at the Biotechnology Research Institute - Suez Canal University
PCR will be used for detection of Enterococcus faecalis Microbiological investigation will be used for counting the number of Enterococcus faecalis
Microbiological sample collection protocol
Two sterile paper points will be introduced into the canals until they reached the full working length and kept in place for 60 seconds 19 Each paper point will be immediately embedded in 3ml sterile tube containing adequate transporting medium or saline solution
The first tube will be transported to the microbiological laboratory for culturing within a maximum of 2 hours while the other tube will be kept at -80 C for DNA extraction and direct detection of Enterococcus faecalis via multiplex PCR assay
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None