Clinical evaluation of post-operative pain in patients with single rooted teeth with apical periodontitis requiring non-surgical endodontic retreatment after three different supplementary irrigation protocol
As post operative pain in teeth requiring non surgical retreatment is a common and unpleasant situation, this study could help decreasing patient's post endodontic pain using three different supplementary irrigation protocol
Design
Randomized clinical trial, blinded, with parallel groups design of 60 patients, between September 2021and march 2022
Settings and conduct
In this study we are evaluating post endodontic pain in 60 patients with single root teeth referring to the khurasgan dental department who met the inclusion criteria. The prevalence and intensity of post operative pain after three different activation of irrigation PUI, XP-endo Finisher files and gentle file system would be analyzed.
Participants/Inclusion and exclusion criteria
18-65 years old healthy patients who has indication of retreatment and experienced moderate-to-severe pain represented on a visual analogue scale (VAS) and status of the periapical tissues were 3 or more according
to the periapical index (PAI). patients having severe pain and/or acute apical abscesses, using analgesics within the last 12 hours or any kind of anti inflammatory or narcotics, allergic to the non-steroidal anti-inflammatory drugs. and also patients with gastrointestinal disorders and pregnant or nursing women will exclude from the study
Intervention groups
According to the final irrigation activation procedures patients would divided into one of these three separate groups:
Group 1: Final irrigation activation with Passive Ultrasonic Irrigation(PUI)
Group 2: Final irrigation activation with Gentlefile system
Group 3: Final irrigation activation with XP-endo Finisher files.
Main outcome variables
Pain intensity, Pain prevalence
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20210501051147N1
Registration date:2022-06-06, 1401/03/16
Registration timing:retrospective
Last update:2022-06-06, 1401/03/16
Update count:0
Registration date
2022-06-06, 1401/03/16
Registrant information
Name
Sadaf Mahmoudi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3535 4001
Email address
sadaf.mahmoudi@khuisf.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-09-23, 1400/07/01
Expected recruitment end date
2022-03-21, 1401/01/01
Actual recruitment start date
2021-09-23, 1400/07/01
Actual recruitment end date
2022-06-01, 1401/03/11
Trial completion date
2022-06-01, 1401/03/11
Scientific title
Clinical evaluation of post-operative pain in patients with single rooted teeth with apical periodontitis requiring non-surgical endodontic retreatment after three different supplementary irrigation protocol
Public title
Evaluation of post-operative pain after three different supplementary irrigation protocol in non-surgical endodontic retreatment cases
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Volunteer patients ranging between 18 and 65 years in age.
Completely healthy patients
Patients with single rooted teeth with apical periodontitis and up to 5 degrees curve requiring non-surgical endodontic retreatment which referred to the dental department of Khurasgan university
Patients that experienced moderate-to-severe pain (4–10)—represented on a visual analogue scale (VAS)
Single-rooted teeth with a PAI score of 3 or more
Exclusion criteria:
Patients with severe systemic problems
Patients below 18 and above 65 years old
Patients who referred with severe pain or acute periapical abscess
Patients were using medication such as analgesics or any kind of anti-inflammatory drugs
Patients were allergic to articaine or non-steroidal anti inflammatory drugs (NSAID)
Patients using narcotics
Patients with gastrointestinal disorders
Patients who were pregnant or lactating
Patients for whom proper primary endodontic treatment was impossible
The presence of other teeth requiring RCT
Age
From 18 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Care provider
Sample size
Target sample size:
48
Actual sample size reached:
48
Randomization (investigator's opinion)
Randomized
Randomization description
For randomization all the patients assigned to one of the 3experimental groups using computer sourced random table (www.rando m.org) by a person who did not include in the study. Randomization group number and patient serial number was in the dark envelope which was opened prior to the treatment by the operator to identify which patient belonged to which group
Blinding (investigator's opinion)
Single blinded
Blinding description
Randomization group number and patient serial number was in the dark envelope which was opened prior to the treatment by the operator to identify which patient belonged to which group. Patient were acknowledged about the study and the devices were used but not aware which system was used among the experiment
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Khurasgan University of Medical Sciences
Intervention group: passive ultrasonic irrigation, noncutting tip of U-file ultrasonic tips, tip diameter 20 and taper 0.01%, activation for 20 seconds
Category
Treatment - Devices
2
Description
Intervention group: gentle file system finishing brushes, up and down movements, activation for 2 minutes
Category
Treatment - Devices
3
Description
Intervention group: XP-endo Finisher files, gentle 7-8 millimeter up and down movement, activation for 1 minute
Category
Treatment - Devices
Recruitment centers
1
Recruitment center
Name of recruitment center
Islamic Azad University of Isfahan (Khurasgan) Branch