It is believed that effective debridement of the root canal system prior to filling with aid of chemical irrigants is the key to long-term success of endodontic therapy. The purpose of this study is to compare the antibacterial activity of 2.5% NaOCl and 2% IKI solutions as intracanal disinfectant in infected root canals during one-visit endodontic treatment procedure.For this purpose, thirty single-rooted teeth with necrotic pulps and periapical lesion will be selected acording to the following inclusion/exclusion criteria. Patients who received antibiotic therapy within the past 3 months will be excluded as well as teeth with extensive caries or fractures of the root/crown, teeth with a history of previous endodontic treatment, and cases showing periodontal pockets over 4 mm depth. Possible complications/risks will be explained to the patients and informed consents will obtaine before starting the treatment.
Since the following up of treated patients is also crucial for accurate evaluation of the efficiency of any employed antimicrobial irrigants; the aim of the second stage of the study is to compare and evaluate the healing of treated teeth of those patients after a period of thirty months
The selected thirty single-rooted teeth will divide in to two groups randomly. In group I, 2.5% NaOCl is an irrigant during instrumentation and in group II; canals will initially irrigate with sterile saline during biomechanical preparation and then expose to a 5-minute final irrigation with 2% IKI. Bacterial samples will take before treatment (S1), and at the end of treatment (S2) and the antimicrobial efficacy of each experimental group will be evaluated.After 30 months, patients will recall and examine clinically and radiographically. Presence of sinus tract, swelling, mobility, tenderness to percussion or palpation and probing depth greater than the baseline measures will be recorded by an independent investigator.Post-operative and follow-up images will be evaluated randomly in a dark room with aid of an X-ray view box and magnifying glass and will be given a periapical score according to PAI scoring system.The outcome will be assessed in two ways.First, the changes in PAI score from base line to the follow-up evaluation will be assessed. Second, the dichotomous variables as “healed” or “not healed” will be compared.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT138903264196N1
Registration date:2013-01-19, 1391/10/30
Registration timing:retrospective
Last update:
Update count:0
Registration date
2013-01-19, 1391/10/30
Registrant information
Name
Seyed Abbas Abbaszadegan
Name of organization / entity
Shiraz University of medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 71 1630 7571
Email address
abbaszade@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Shiraz University of Medical Sciences
Expected recruitment start date
2009-12-31, 1388/10/10
Expected recruitment end date
2010-06-01, 1389/03/11
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of clinical and antimicrobial efficacy of 2% IKI and 2.5% sodium hypochlorite irrigants in infected root canals- An in vivo study
Public title
Clinical & antimicrobial effect of iodine potassium iodide
Purpose
Treatment
Inclusion/Exclusion criteria
Only teeth with necrotic pulps as confirmed by negative response to sensitivity pulp tests were included in this study. Patients who received antibiotic therapy within the past 3 months were excluded from the study. Teeth with extensive caries or with fractures of the root/crown and with history of previous endodontic treatment did not consider in the study. Besides, cases showing periodontal pockets over 4 mm depth were also excluded.In the second phase,presence of sinus tract, swelling, mobility, tenderness to percussion or palpation and probing depth greater than the baseline measures will be recorded by an independent investigator and will serve as exclusion criteria
Age
From 18 years old to 70 years old
Gender
Both
Phase
1-2
Groups that have been masked
No information
Sample size
Target sample size:
30
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Shiraz University of Medical Sciences
Street address
خیابان زند-ساختمان مرکزی دانشگاه علوم پزشکی شیراز
City
Shiraz
Postal code
Approval date
2009-12-22, 1388/10/01
Ethics committee reference number
98-5109
Health conditions studied
1
Description of health condition studied
Chronic apical periodontitis
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Bacterial load reduction in post-treatment samples in comparison to initial samples
Timepoint
At the end of trearment session
Method of measurement
Microbial colony forming unit( CFU)
Secondary outcomes
1
Description
Any Change in periapical status from the baseline and presence or absence of clinical sign& symptoms after 30-months
Timepoint
30-months
Method of measurement
Clinical and radiographical evaluation of treated patient after 30-months
Intervention groups
1
Description
Intervention group: After first antimicrobial sampling upon access ( S1), in this group irrigation was carried out with normal saline. Two milliliters of this solution were used to irrigate the canals after each instrument (10mL overall).Each canal was flushed with 2% IKI solution as final rinse for a period of 5 minutes. After inactivation of IKI with 2mL 5% sodium thiosulfate followed by 2mL normal saline, the second microbial sampling (S2) was performed.Subsequently, the canals were filled with gutta-percha and Tubli-Seal sealer (ZOE-based; SybronEndo, Orange, CA, USA) using cold lateral compaction technique. The tooth was temporized and permanent restoration was planned at the next visit.Moreover, the patients will follow-up after 30 months to evaluate the periapical healing of the teeth by clinical and radiological examinations.
Category
Treatment - Other
2
Description
Positive control group: After the first antimicrobial sampling upon access (S1), in this group irrigation was performed with 2 mL 2.5% NaOCl after each instrument (10mL overall).After instrumentation was completed, the canals were flushed with 2 mL 5% sodium thiosulfate followed by 2 mL normal saline and second microbial sampling (S2) was achieved by using 3 sterile paper cones. Subsequently, the canals were filled with gutta-percha and Tubli-Seal sealer (ZOE-based; SybronEndo, Orange, CA, USA) using cold lateral compaction technique. The tooth was temporized and permanent restoration was planned at the next visit. Moreover, the patient will follow-up 30 months after treatment to monitor the healing of periapical lesion by clinical and radilogical examinations.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Dental Clinic at shiraz Dental School
Full name of responsible person
Street address
City
Shiraz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shiraz university of Medical Scienced
Full name of responsible person
Dr.Poostforoosh
Street address
Cenral University buildingوZand st
City
Shiraz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shiraz university of Medical Scienced
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Faculty of Dentistry,Shiraz Universsity of Medical Sciences
Full name of responsible person
Abbas Abbaszadegan
Position
Assistant professor
Other areas of specialty/work
Street address
Ghasrodasht st,Ghomabad st
City
Shiraz
Postal code
Phone
+98 917 302 8781
Fax
+98 917 302 8781
Email
dr.abbaszadegan@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Faculty of Dentistry,Shiraz University of Medical Sciences
Full name of responsible person
Mohammadreza Nabavizadeh
Position
Assistant professor
Other areas of specialty/work
Street address
Ghasrodasht st,Ghomabad st
City
Shiraz
Postal code
Phone
+98 917 302 9846
Fax
Email
mohammadrezanabavizadeh@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
School of Dentistry,Shiraz University of Medical Sciences
Full name of responsible person
Abbas Abbaszadegan
Position
Assistant professor of Endodontics
Other areas of specialty/work
Street address
Ghasrodasht st,Ghomabad St,Shiraz Dental School
City
Shiraz
Postal code
7186634848
Phone
+98 71 1630 6236
Fax
Email
dr.abbaszadegan@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)