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Recruitment centers
#1
Name of recruitment center - English: Vali- Asr clinic
Name of recruitment center - Persian: مرکز درمانی ولیعصر
Full name of responsible person - English: Arash Ghanbarzadegan
Full name of responsible person - Persian: آرش قنبرزادگان
Street address - English: Meimand entrance St
Street address - Persian: خیابان ورودی میمند
City - English: Meimand
City - Persian: میمند
Province: Fars
Country: Iran (Islamic Republic of)
Postal code: 7134798156
Phone: +98 71 3877 2007
Fax:
Email: arash.ghanbarzadegan@yahoo.com
Web page address:
Name of recruitment center - English: Vali- Asr clinic
Name of recruitment center - Persian: مرکز درمانی ولیعصر
Full name of responsible person - English: Arash Ghanbarzadegan
Full name of responsible person - Persian: آرش قنبرزادگان
Street address - English: Meimand entrance St
Street address - Persian: خیابان ورودی میمند
City - English: Meimand
City - Persian: میمند
Province: Fars
Country: Iran (Islamic Republic of)
Postal code: ---------
Phone: +98 71 3877 2007
Fax:
Email: arash.ghanbarzadegan@yahoo.com
Web page address:
Name of recruitment center - English: Vali- Asr clinic Name of recruitment center - Persian: مرکز درمانی ولیعصر Full name of responsible person - English: Arash Ghanbarzadegan Full name of responsible person - Persian: آرش قنبرزادگان Street address - English: Meimand entrance St Street address - Persian: خیابان ورودی میمند City - English: Meimand City - Persian: میمند Province: Fars Country: Iran (Islamic Republic of) Postal code: 7134798156--------- Phone: +98 71 3877 2007 Fax: Email: arash.ghanbarzadegan@yahoo.com Web page address:
Person responsible for general inquiries
Name of organization / entity - English:
Name of organization / entity - Persian:
Full name of responsible person - English: Arash Ghanbarzadegan
Full name of responsible person - Persian: آرش قنبرزادگان
Position - English: Researcher Dentist
Position - Persian: دندانپزشک محقق
Latest degree: med_doctor
Area of specialty/work: 43
Area of specialty/work title - English:
Area of specialty/work title - Persian:
Street address - English: Baran Building, 12th Ave., Faghihi St., Zand Blvd.
Street address - Persian: ساختمان باران، کوچه 12، خیابان شهید فقیهی، بلوار زند.
City - English: shiraz
City - Persian: شیراز
Province: Fars
Province - English:
Province - Persian:
contact.provinces_available: 1
Country: Iran (Islamic Republic of)
Postal code: 7134798156
Phone: +98 71 3235 0378
Mobile: +98 930 109 2412
Fax:
Email: Arash.ghanbarzadegan@yahoo.com
Web page address:
Name of organization / entity - English:
Name of organization / entity - Persian:
Full name of responsible person - English: Arash Ghanbarzadegan
Full name of responsible person - Persian: آرش قنبرزادگان
Position - English: Researcher Dentist
Position - Persian: دندانپزشک محقق
Latest degree: med_doctor
Area of specialty/work: 43
Area of specialty/work title - English:
Area of specialty/work title - Persian:
Street address - English: Etemadzadeh St., West Fatemi St.
Street address - Persian: خیابان شهید اعتماد زاده، خیابان فاطمی غربی
City - English: Tehran
City - Persian: تهران
Province: Fars
Province - English:
Province - Persian:
contact.provinces_available: 1
Country: Iran (Islamic Republic of)
Postal code: 1411718541
Phone: +98 21 8609 6351
Mobile: +98 930 109 2412
Fax:
Email: Arash.ghanbarzadegan@yahoo.com
Web page address:
Name of organization / entity - English: Name of organization / entity - Persian: Full name of responsible person - English: Arash Ghanbarzadegan Full name of responsible person - Persian: آرش قنبرزادگان Position - English: Researcher Dentist Position - Persian: دندانپزشک محقق Latest degree: med_doctor Area of specialty/work: 43 Area of specialty/work title - English: Area of specialty/work title - Persian: Street address - English: Baran Building, 12th Ave., FaghihiEtemadzadeh St., Zand BlvdWest Fatemi St. Street address - Persian: ساختمان باران، کوچه 12خیابان شهید اعتماد زاده، خیابان شهید فقیهی، بلوار زند.فاطمی غربی City - English: shirazTehran City - Persian: شیرازتهران Province: Fars Province - English: Province - Persian: contact.provinces_available: 1 Country: Iran (Islamic Republic of) Postal code: 71347981561411718541 Phone: +98 71 3235 037821 8609 6351 Mobile: +98 930 109 2412 Fax: Email: Arash.ghanbarzadegan@yahoo.com Web page address:
Person responsible for scientific inquiries
Name of organization / entity - English:
Name of organization / entity - Persian:
Full name of responsible person - English: Arash Ghanbarzadegan
Full name of responsible person - Persian: آرش قنبرزادگان
Position - English: Dental researcher
Position - Persian: دندانپزشک پژوهشگر
Latest degree: med_doctor
Area of specialty/work: 43
Area of specialty/work title - English:
Area of specialty/work title - Persian:
Street address - English: Moalem st. aja dental school, endodontics department
Street address - Persian: خیابان معلم، دانشکده دندانپزشکی آجا، بخش اندودنتیکس
City - English: Tehran
City - Persian: تهران
Province: Tehran
Province - English:
Province - Persian:
contact.provinces_available: 1
Country: Iran (Islamic Republic of)
Postal code: 7134798156
Phone: +98 71 1235 0378
Mobile: +98 930 109 2412
Fax:
Email: arash.ghanbarzadegan@yahoo.com
Web page address:
Name of organization / entity - English:
Name of organization / entity - Persian:
Full name of responsible person - English: Arash Ghanbarzadegan
Full name of responsible person - Persian: آرش قنبرزادگان
Position - English: Dental researcher
Position - Persian: دندانپزشک پژوهشگر
Latest degree: med_doctor
Area of specialty/work: 43
Area of specialty/work title - English:
Area of specialty/work title - Persian:
Street address - English: Moalem st. aja dental school, endodontics department
Street address - Persian: خیابان معلم، دانشکده دندانپزشکی آجا، بخش اندودنتیکس
City - English: Tehran
City - Persian: تهران
Province: Tehran
Province - English:
Province - Persian:
contact.provinces_available: 1
Country: Iran (Islamic Republic of)
Postal code: 1411718541
Phone: +98 21 8609 6351
Mobile: +98 930 109 2412
Fax:
Email: arash.ghanbarzadegan@yahoo.com
Web page address:
Name of organization / entity - English: Name of organization / entity - Persian: Full name of responsible person - English: Arash Ghanbarzadegan Full name of responsible person - Persian: آرش قنبرزادگان Position - English: Dental researcher Position - Persian: دندانپزشک پژوهشگر Latest degree: med_doctor Area of specialty/work: 43 Area of specialty/work title - English: Area of specialty/work title - Persian: Street address - English: Moalem st. aja dental school, endodontics department Street address - Persian: خیابان معلم، دانشکده دندانپزشکی آجا، بخش اندودنتیکس City - English: Tehran City - Persian: تهران Province: Tehran Province - English: Province - Persian: contact.provinces_available: 1 Country: Iran (Islamic Republic of) Postal code: 71347981561411718541 Phone: +98 71 1235 037821 8609 6351 Mobile: +98 930 109 2412 Fax: Email: arash.ghanbarzadegan@yahoo.com Web page address:
Person responsible for updating data
Name of organization / entity - English:
Name of organization / entity - Persian:
Full name of responsible person - English: Arash Ghanbarzadegan
Full name of responsible person - Persian: آرش قنبرزادگان
Position - English: Dental researcher
Position - Persian: دندانپزشک پژوهشگر
Latest degree: med_doctor
Area of specialty/work: 43
Area of specialty/work title - English:
Area of specialty/work title - Persian:
Street address - English: Moalem st. aja dental school, endodontics department
Street address - Persian: خیابان معلم، دانشکده دندانپزشکی آجا، بخش اندودنتیکس
City - English: Tehran
City - Persian: تهران
Province: Tehran
Province - English:
Province - Persian:
contact.provinces_available: 1
Country: Iran (Islamic Republic of)
Postal code: 7134798156
Phone: +98 71 1235 0378
Mobile: +98 930 109 2412
Fax:
Email: arash.ghanbarzadegan@yahoo.com
Web page address:
Name of organization / entity - English:
Name of organization / entity - Persian:
Full name of responsible person - English: Arash Ghanbarzadegan
Full name of responsible person - Persian: آرش قنبرزادگان
Position - English: Dental researcher
Position - Persian: دندانپزشک پژوهشگر
Latest degree: med_doctor
Area of specialty/work: 43
Area of specialty/work title - English:
Area of specialty/work title - Persian:
Street address - English: Moalem st. aja dental school, endodontics department
Street address - Persian: خیابان معلم، دانشکده دندانپزشکی آجا، بخش اندودنتیکس
City - English: Tehran
City - Persian: تهران
Province: Tehran
Province - English:
Province - Persian:
contact.provinces_available: 1
Country: Iran (Islamic Republic of)
Postal code: 1411718541
Phone: +98 21 8609 6351
Mobile: +98 930 109 2412
Fax:
Email: arash.ghanbarzadegan@yahoo.com
Web page address:
Name of organization / entity - English: Name of organization / entity - Persian: Full name of responsible person - English: Arash Ghanbarzadegan Full name of responsible person - Persian: آرش قنبرزادگان Position - English: Dental researcher Position - Persian: دندانپزشک پژوهشگر Latest degree: med_doctor Area of specialty/work: 43 Area of specialty/work title - English: Area of specialty/work title - Persian: Street address - English: Moalem st. aja dental school, endodontics department Street address - Persian: خیابان معلم، دانشکده دندانپزشکی آجا، بخش اندودنتیکس City - English: Tehran City - Persian: تهران Province: Tehran Province - English: Province - Persian: contact.provinces_available: 1 Country: Iran (Islamic Republic of) Postal code: 71347981561411718541 Phone: +98 71 1235 037821 8609 6351 Mobile: +98 930 109 2412 Fax: Email: arash.ghanbarzadegan@yahoo.com Web page address:
Trial results
No
Yes
1
empty
2023-01-29, 1401/11/09
2023-01-29 05:05:39
empty
2019-01-20, 1397/10/30
2019-01-20 00:00:00
empty
https://doi.org/10.22037/iej.v14i1.22815
https://doi.org/10.22037/iej.v14i1.22815
empty
Abstract
Introduction: After treating the tooth root canal, pain is one of the problems that many patients are facing. In order to reduce pain, and regarding the advice of treating necrotic teeth during several sessions, intra-canal medicaments can be used between sessions. The purpose of this study is to compare pain relieving effect of calcium hydroxide combined with three solutions of normal saline, chlorhexidine 2% and dexamethasone. Materials and methods: This triple blind randomized clinical trial was performed on 90 necrotic molars and premolars. The patients were classified in three medicaments' groups including mixture of calcium hydroxide and normal saline (G1), chlorhexidine 2% (G2) or dexamethasone (G3) that were placed in the canal during the first treatment session. The patients were provided with a Heft-Parker Visual Analog Scale form to record their pain in different intervals of 4, 24, 48, 72 and 96 h after cleaning and shaping the root canal. Data analysis was carried out using the Chi-Square, one-way ANOVA and Repeated Measure tests. Results: No significant difference was observed in the mean pain of the groups after 4 h (P>0.05). However, a significant difference was found between G1 and G3 in the mean pain from day 1 to 72 h after treatment. The mean pain was less in dexamethasone (G3) group (P<0.05), but the difference was not statistically significant at 96 h after treatment (P>0.05). No significant difference was found between "G2-G1" and "G2-G3" groups at different time intervals (P>0.05). Conclusion: The mixture of calcium hydroxide and dexamethasone compared to calcium hydroxide and normal saline in short and medium time had a significant effect on reducing pain after cleaning and shaping the root canal. It seems that the mixture of calcium hydroxide and dexamethasone can be considered as an effective medicament on reducing pain during root canal treatment sessions.
Abstract Introduction: After treating the tooth root canal, pain is one of the problems that many patients are facing. In order to reduce pain, and regarding the advice of treating necrotic teeth during several sessions, intra-canal medicaments can be used between sessions. The purpose of this study is to compare pain relieving effect of calcium hydroxide combined with three solutions of normal saline, chlorhexidine 2% and dexamethasone. Materials and methods: This triple blind randomized clinical trial was performed on 90 necrotic molars and premolars. The patients were classified in three medicaments' groups including mixture of calcium hydroxide and normal saline (G1), chlorhexidine 2% (G2) or dexamethasone (G3) that were placed in the canal during the first treatment session. The patients were provided with a Heft-Parker Visual Analog Scale form to record their pain in different intervals of 4, 24, 48, 72 and 96 h after cleaning and shaping the root canal. Data analysis was carried out using the Chi-Square, one-way ANOVA and Repeated Measure tests. Results: No significant difference was observed in the mean pain of the groups after 4 h (P>0.05). However, a significant difference was found between G1 and G3 in the mean pain from day 1 to 72 h after treatment. The mean pain was less in dexamethasone (G3) group (P<0.05), but the difference was not statistically significant at 96 h after treatment (P>0.05). No significant difference was found between "G2-G1" and "G2-G3" groups at different time intervals (P>0.05). Conclusion: The mixture of calcium hydroxide and dexamethasone compared to calcium hydroxide and normal saline in short and medium time had a significant effect on reducing pain after cleaning and shaping the root canal. It seems that the mixture of calcium hydroxide and dexamethasone can be considered as an effective medicament on reducing pain during root canal treatment sessions.
Protocol summary
Study aim
Assessment and comparison of pain relief effect of three intracanal medicament after cleaning and shaping of tooth root canal.
Design
Three blinded randomized trial (randomized by random number table) which will conduct to compare pain relieving effect of three root canal medicaments.
Settings and conduct
Patients referring to office of the conductor dentist of the study are the target group. Patient, dentist and statistical analyzer will be blinded and drugs will be prepared and given to the dentist by the dental assistant
Participants/Inclusion and exclusion criteria
inclusion criteria: without any systemic diseases, molar or premolar tooth with necrotic pulp, permanent and closed apex tooth, tooth shouldn't have any kind of resorption and patient should not use any NSAIDS in last three hours before treatment.
exclusion criteria: patient won't come for the following treatment appointment, patient doesn't prefer to collaborate and don't complete the pain in the charts by the patient.
Intervention groups
this study includes three case groups: treatment will done by mixture of "calcium hydroxide and %0/9 normal saline", "calcium hydroxide and %2 Chlorhexidine" and "calcium hydroxide and dexamethasone (8mg/2cc)". after cleaning and shaping one of these mentioned medicament will apply in root canal for comparison of their pain relieving effect.
Main outcome variables
inter appointments pain.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180521039766N1
Registration date:2018-06-25, 1397/04/04
Registration timing:registered_while_recruiting
Last update:2023-01-29, 1401/11/09
Update count:1
Registration date
2018-06-25, 1397/04/04
Registrant information
Name
Arash Ghanbarzadegan
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 71 1235 0378
Email address
arash.ghanbarzadegan@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-06-22, 1397/04/01
Expected recruitment end date
2018-09-23, 1397/07/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Study of the Efficacy of Intracanal Medicaments on Tooth Root Canal Treatment Pain Management
Public title
Intracanal Medicaments and Root Canal Treatment Pain
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
without any systemic diseases
molar or premolar tooth with necrotic pulp
permanent and closed apex tooth
tooth shouldn't have any kind of resorption
patient should not use any NSAIDS in last three hours before treatment
Exclusion criteria:
patient won't come for the following treatment appointment
patient doesn't prefer to collaborate
don't complete the pain in the charts by the patient
Age
No age limit
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Investigator
Sample size
Target sample size:
90
Randomization (investigator's opinion)
Randomized
Randomization description
patient will be select by random number table.
Blinding (investigator's opinion)
Triple blinded
Blinding description
Patient, dentist and statistical analyzer will be blinded and drugs will be prepared and given to the dentist by the dental assistant.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Aja University of Medical Sciences
Street address
Etemadzadeh St., West Fatemi St.
City
Tehran
Province
Tehran
Postal code
1411718541
Approval date
2018-06-03, 1397/03/13
Ethics committee reference number
IR.AJAUMS.REC.1397.005
Health conditions studied
1
Description of health condition studied
inter appointments pain after cleaning and shaping of root canal
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
inter appointments pain after cleaning and shaping of tooth root canal
Timepoint
4 hours after treatment, the first day, the second day, the third day and the fourth day.
Method of measurement
Visual Analog Scale
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: treated by mixture of calcium hydroxide and %0/9 normal saline.
Category
Treatment - Drugs
2
Description
Intervention group: treated by mixture of calcium hydroxide and %2 Chlorhexidine.
Category
Treatment - Drugs
3
Description
Intervention group: treated by mixture of calcium hydroxide and dexamethasone (8mg/2cc).
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Vali- Asr clinic
Full name of responsible person
Arash Ghanbarzadegan
Street address
Meimand entrance St
City
Meimand
Province
Fars
Postal code
---------
Phone
+98 71 3877 2007
Email
arash.ghanbarzadegan@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Artesh University of Medical Sciences
Full name of responsible person
Dr. Mostafa Shahrezaei
Street address
Etemadzadeh St., West Fatemi St.
City
Tehran
Province
Tehran
Postal code
1411718541
Phone
+98 21 8609 6351
Email
info@ajaums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Artesh University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Artesh University of Medical Sciences
Full name of responsible person
Arash Ghanbarzadegan
Position
Researcher Dentist
Latest degree
Medical doctor
Other areas of specialty/work
Dentistry
Street address
Etemadzadeh St., West Fatemi St.
City
Tehran
Province
Fars
Postal code
1411718541
Phone
+98 21 8609 6351
Email
Arash.ghanbarzadegan@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Artesh University of Medical Sciences
Full name of responsible person
Arash Ghanbarzadegan
Position
Dental researcher
Latest degree
Medical doctor
Other areas of specialty/work
Dentistry
Street address
Moalem st. aja dental school, endodontics department
City
Tehran
Province
Tehran
Postal code
1411718541
Phone
+98 21 8609 6351
Fax
Email
arash.ghanbarzadegan@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Artesh University of Medical Sciences
Full name of responsible person
Arash Ghanbarzadegan
Position
Dental researcher
Latest degree
Medical doctor
Other areas of specialty/work
Dentistry
Street address
Moalem st. aja dental school, endodontics department
City
Tehran
Province
Tehran
Postal code
1411718541
Phone
+98 21 8609 6351
Fax
Email
arash.ghanbarzadegan@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Not applicable
Data Dictionary
Not applicable
Trial results
Please tick if results have been published
Yes
Summary result posting date
2023-01-29, 1401/11/09
Table of baseline comparison
Participant flow diagram
Table of variable outcomes' results
Table of adverse events
First publication date
2019-01-20, 1397/10/30
Abstract of published paper
Abstract
Introduction: After treating the tooth root canal, pain is one of the problems that many patients are facing. In order to reduce pain, and regarding the advice of treating necrotic teeth during several sessions, intra-canal medicaments can be used between sessions. The purpose of this study is to compare pain relieving effect of calcium hydroxide combined with three solutions of normal saline, chlorhexidine 2% and dexamethasone. Materials and methods: This triple blind randomized clinical trial was performed on 90 necrotic molars and premolars. The patients were classified in three medicaments' groups including mixture of calcium hydroxide and normal saline (G1), chlorhexidine 2% (G2) or dexamethasone (G3) that were placed in the canal during the first treatment session. The patients were provided with a Heft-Parker Visual Analog Scale form to record their pain in different intervals of 4, 24, 48, 72 and 96 h after cleaning and shaping the root canal. Data analysis was carried out using the Chi-Square, one-way ANOVA and Repeated Measure tests. Results: No significant difference was observed in the mean pain of the groups after 4 h (P>0.05). However, a significant difference was found between G1 and G3 in the mean pain from day 1 to 72 h after treatment. The mean pain was less in dexamethasone (G3) group (P<0.05), but the difference was not statistically significant at 96 h after treatment (P>0.05). No significant difference was found between "G2-G1" and "G2-G3" groups at different time intervals (P>0.05). Conclusion: The mixture of calcium hydroxide and dexamethasone compared to calcium hydroxide and normal saline in short and medium time had a significant effect on reducing pain after cleaning and shaping the root canal. It seems that the mixture of calcium hydroxide and dexamethasone can be considered as an effective medicament on reducing pain during root canal treatment sessions.