Comparison the effect of sodium Hypochlorite and Super oxidized water on Endodontic postoperative pain in human necrotic single canal tooth ( Clinical trial )
Comparison the effect of superoxidized water with sodium hypochlorite on postoperative pain intensity after single root canall treatment On patients in the endodontics department of the School of Dentistry Islamic azad university in1400-1401
Design
Clinical trial with control group,with parallel groups,double-blind,randomized,phase 2 on 70 patients
Settings and conduct
All steps are performed by the first year specialist assistants in Azad Tehran's Dental school؛Blinding has been done as a cover among participants and clinical caregivers
Participants/Inclusion and exclusion criteria
Anterior single canal human teeth Teeth which without internal or external root absorption Teeth which without calcification Teeth which without caries in root Root curvature of teeth Less than 15 degrees All samples will have mature apex All samples will have necrotic pulp The patient of choice should be without systemic disease The selected tooth has normal apical All samples will have Sensivity to Percussion The patient should not use pollen for at least 6 hours before treatment The patient must be at least 18 years old and at most 65 years old The patient should not be allergic to lidocaine 1/80,000 Female patients should not be pregnant The patient should not have Severe periodontal disease Teeth should not have restoration
Intervention groups
Channel preparation is done with the help of a rotary machine and continuous washing. In channel preparation, all channels are prepared up to file number 40, and in all cases root canal treatment will be performed while maintaining patency. During the canal preparation process, in the first group, 2 ml of 5% sodium hypochlorite solution and in the second group, 2 ml of 50% superoxide water are applied as a rinse by a 30 gauge needle with a side hole.
Main outcome variables
Postoperative pain in case and control groups
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20220113053707N1
Registration date:2022-01-18, 1400/10/28
Registration timing:prospective
Last update:2022-01-18, 1400/10/28
Update count:0
Registration date
2022-01-18, 1400/10/28
Registrant information
Name
Ehsan Esnaashari
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2279 3163
Email address
ehsan_dmd@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-02-20, 1400/12/01
Expected recruitment end date
2022-08-11, 1401/05/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison the effect of sodium Hypochlorite and Super oxidized water on Endodontic postoperative pain in human necrotic single canal tooth ( Clinical trial )
Public title
Effect of sodium Hypochlorite and Super oxidized water on postoperative pain
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Anterior single canal human teeth will chosen.
The sample teeth should not have internal or external root resorption.
Teeth which without calcification.
After preparing the periapical radiograph, the curvature of the roots will be determined by Schneider method and samples with a curvature of less than 15 degrees will be selected.
The selected tooth has no apical lesion.
All samples will have mature apex.
All samples will have necrotic pulp.
.The patient of choice should be without systemic disease.
The patient must be at least 18 years old and at most 65 years old .
Exclusion criteria:
Teeth should not have restorations.
The patient should not have Severe periodontal disease.
Female patients should not be pregnant.
The patient should not be allergic to 2% lidocaine .
The patient should not use any drugs for at least 6 hours before treatment.
Age
From 18 years old to 65 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Sample size
Target sample size:
70
Randomization (investigator's opinion)
Randomized
Randomization description
Simple randomization - Individual- Randomizitioan with closed envelop. Using the rand option of Excel software, the samples will be divided into 4 blocks by complete block randomization method. This process is performed by a person who is not present in the clinical work and follow-up of patients (statistics and methodology consultant) and the type of intervention will be provided to the researcher in envelopes in numbered packages and the researcher will open the lock immediately The type of specialized intervention will be informed.
Blinding (investigator's opinion)
Double blinded
Blinding description
Patients do not know which solution to brush their teeth with. Clinical caregivers also do not know what detergent they are using.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research Ethics Committees of Islamic Azad University Dental Branch Tehran - Iran
Street address
Pasdaran
City
Tehran
Province
Tehran
Postal code
1946853314
Approval date
2022-01-10, 1400/10/20
Ethics committee reference number
IR.IAU.DENTAL.REC.1400.146
Health conditions studied
1
Description of health condition studied
Post Operative Pain
ICD-10 code
R52
ICD-10 code description
Pain, unspecified
Primary outcomes
1
Description
Postoperatrive pain in anterior teeth single canal
Timepoint
6h. 12h. 24h. 48h. 72h .7D
Method of measurement
Information form
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: 35 teeth, all of which have been prepared with the help of a rotary device and up to 40 files, and in all cases, root canal treatment will be performed while maintaining patency. These teeth are rinsed with 50% superoxide water (Khosro Medisa Teb) and 30 gauge needles with side holes.
Category
Treatment - Devices
2
Description
Control group: 35 teeth are prepared in the same way as the intervention group and are rinsed with 5% Sodium Hypochlorite Solution.
Category
Treatment - Devices
Recruitment centers
1
Recruitment center
Name of recruitment center
Dental School of Islamic Azad University of Tehran
Full name of responsible person
Amirabbas Moshari
Street address
Pasdaran
City
Tehran
Province
Tehran
Postal code
1946853314
Phone
+98 21 2256 4571
Email
amirabbas.moshari@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Islamic Azad University
Full name of responsible person
Dr.Arash Azizi
Street address
Pasdaran
City
Tehran
Province
Tehran
Postal code
1946853314
Phone
+98 21 2256 4571
Email
amirabbas.moshari@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?