Ignite Creation Date:
2024-10-26 @ 3:38 PM
Last Modification Date:
2024-10-26 @ 3:38 PM
Study NCT ID:
NCT06569329
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-08-19
Brief Title:
Bacterial Reduction After Supplementary Disinfection Procedures in Infected Root Canals
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Bacterial Reduction After Supplementary Disinfection Procedures in Infected Root Canals
Status:
RECRUITING
Status Verified Date:
2024-08
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:
The purpose of this study is to understand the effect that 3 different types of root canal procedures have on bacteria
Detailed Description:
Sample Size Calculation Sample size was calculated by STATISTICA v80 software StatSoft Tulsa OK USA that demonstrated 23 teeth per group are needed to show a 5 difference in bacterial levels at 90 power Considering possible losses ninety adult subjects will be selected
Case Selection and Eligibility Criteria Participants will be recruited at the Endodontic Clinic at the University of Iowa The inclusion criteria will be patients 18 years or older teeth with intact pulp chamber walls no response to cold and electric pulp testing and apical periodontitis
Teeth with vital pulp incomplete root formation extensive crown destruction previous endodontic treatment or intervention pulp debridement acute chronic apical abscess internal or external resorption non-odontogenic facial pain periodontal probing deeper than 4 mm advanced untreated periodontal disease or recent periodontal surgery teeth with mobility score 2 fracture or visible crack patients with diabetes or immune-compromised conditions patients who received systemic antibiotics within the last three months or taking corticosteroids and pregnancy will be excluded
Study Intervention Root canal samples will be taken under strict asepsis as described by Rodrigues et al 21 Operative field will be disinfected using 3 hydrogen peroxide and 3 NaOCl under rubber dam isolation Once the access cavity is prepared 10 sodium thiosulfate solution will be injected into the pulp chamber and the sterility control SC will be taken from the access cavity walls internal surfaces using sterile paper points This sample will be transferred aseptically to a cryotube containing RNA later Ambion Austin TX and stored at -20C
The first sample S1 will be taken as the baseline quantity of bacteria before chemomechanical preparation One ml of 10 sodium thiosulfate solution will be injected into the canal and a sterile paper point will be introduced up to that length for 1 minute transferred in cryotubes containing RNA later and stored at -20C
The root canal will be shaped and cleaned using rotary endodontic instruments up to size 3504 with periodic irrigation with 5 mL of 3 NaOCl between each instrumentation After apical preparation the canal will be dried with sterile paper points and then washed with 1 mL of 10 sodium thiosulfate for 1 minute to inactivate NaOCl After that a second sample S2 will be collected and stored as described for S1
Teeth specimens will be randomly assigned to three groups n30 according to the type of supplementary disinfection approaches used 1 GWS 2 LAI and 3 UAI These devices will be used as stated above in phase 1 of this study After using supplementary disinfection approaches a third sample S3 will be collected from the root canal and stored as described above for S1 and S2
Case Selection and Eligibility Criteria Participants will be recruited at the Endodontic Clinic at the University of Iowa The inclusion criteria will be patients 18 years or older teeth with intact pulp chamber walls no response to cold and electric pulp testing and apical periodontitis
Teeth with vital pulp incomplete root formation extensive crown destruction previous endodontic treatment or intervention pulp debridement acute chronic apical abscess internal or external resorption non-odontogenic facial pain periodontal probing deeper than 4 mm advanced untreated periodontal disease or recent periodontal surgery teeth with mobility score 2 fracture or visible crack patients with diabetes or immune-compromised conditions patients who received systemic antibiotics within the last three months or taking corticosteroids and pregnancy will be excluded
Study Intervention Root canal samples will be taken under strict asepsis as described by Rodrigues et al 21 Operative field will be disinfected using 3 hydrogen peroxide and 3 NaOCl under rubber dam isolation Once the access cavity is prepared 10 sodium thiosulfate solution will be injected into the pulp chamber and the sterility control SC will be taken from the access cavity walls internal surfaces using sterile paper points This sample will be transferred aseptically to a cryotube containing RNA later Ambion Austin TX and stored at -20C
The first sample S1 will be taken as the baseline quantity of bacteria before chemomechanical preparation One ml of 10 sodium thiosulfate solution will be injected into the canal and a sterile paper point will be introduced up to that length for 1 minute transferred in cryotubes containing RNA later and stored at -20C
The root canal will be shaped and cleaned using rotary endodontic instruments up to size 3504 with periodic irrigation with 5 mL of 3 NaOCl between each instrumentation After apical preparation the canal will be dried with sterile paper points and then washed with 1 mL of 10 sodium thiosulfate for 1 minute to inactivate NaOCl After that a second sample S2 will be collected and stored as described for S1
Teeth specimens will be randomly assigned to three groups n30 according to the type of supplementary disinfection approaches used 1 GWS 2 LAI and 3 UAI These devices will be used as stated above in phase 1 of this study After using supplementary disinfection approaches a third sample S3 will be collected from the root canal and stored as described above for S1 and S2
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