To compare the frequency of post-operative/post-obturation pain experienced by the patient with ibuprofen/ dexamethasone infiltration compared to ibuprofen alone in a single visit endodontic procedure.
Design
Single blinded , Randomized Controlled Trial (RCT)
Settings and conduct
Operative Dentistry Department of Islamic International Dental Hospital - Islamabad, Pakistan
All patients were assigned randomly into two equal groups, group A and group B, using randomization codes in opaque sealed envelopes.
In Group A, after RCT, single shot local infiltration of 0.5 mg dexamethasone was given in periapical area. In Group B, after RCT local infiltration of placebo was given. Both patient groups were prescribed ibuprofen 400mg three times a day.
only the participants were blinded by the placebo infiltration .
Participants/Inclusion and exclusion criteria
INCLUSION : Patients of both genders aged 16-45 years with non-vital asymptomatic maxillary single rooted tooth with necrotic pulp.
EXCLUSION : • Teeth having extensive intra canal calcification.
• Teeth with incompletely formed apices.
• Teeth requiring retreatment.
• Taking analgesics, anti-inflammatory or tri-cyclic anti-depressants. 5
• Allergy to endodontic medication.
• Teeth with grade II or III mobility (more than 2 mm)
Intervention groups
In Group A, after RCT, single shot local infiltration of 0.5 mg dexamethasone was given in periapical area. In Group B, after RCT local infiltration of silane ( placebo) was given. Both patient groups were prescribed ibuprofen 400mg three times a day.
Main outcome variables
Pain reported by patient at the end of endodontic treatment after 24, 48 and 72 hours using Visual Analogue Scale (VAS).
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20230713058771N2
Registration date:2023-09-26, 1402/07/04
Registration timing:registered_while_recruiting
Last update:2023-09-26, 1402/07/04
Update count:0
Registration date
2023-09-26, 1402/07/04
Registrant information
Name
Asim Qureshi
Name of organization / entity
Ayub medical and dental college
Country
Pakistan
Phone
+92 340 9053423
Email address
asim@ayubmed.edu.pk
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-08-10, 1402/05/19
Expected recruitment end date
2024-01-10, 1402/10/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of Ibuprofen and Ibuprofen/Dexamethasone Infiltration on Post- Operative Pain in Single Visit Endodontics
Public title
Effect of Ibuprofen and Ibuprofen/Dexamethasone Infiltration on Post- Operative Pain in Single Visit Endodontics
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients of both genders aged 16-45 years with non-vital asymptomatic maxillary single rooted tooth with necrotic pulp.
Exclusion criteria:
• Teeth having extensive intra canal calcification.
• Teeth with incompletely formed apices
• Teeth requiring retreatment
• Taking analgesics, anti-inflammatory or tri-cyclic anti-depressants
• Allergy to endodontic medication
• Teeth with grade II or III mobility (more than 2 mm)
Age
From 16 years old to 45 years old
Gender
Both
Phase
2
Groups that have been masked
Participant
Sample size
Target sample size:
90
Randomization (investigator's opinion)
Randomized
Randomization description
After proper history taking , investigations and formal consent. Subject was considered in one of our two groups by random allocation (lottery method). In this method each subject was asked to pick a sealed envelope out of the total 90. Each sealed envelope marked which group the subject will be put in. This was concealed from the subject.
Blinding (investigator's opinion)
Single blinded
Blinding description
In Group A, after RCT, single shot local infiltration of 0.5 mg dexamethasone will given in periapical area. In Group B, after RCT local infiltration single shot of placebo(saline) 0.5 mg will be given at periapical area. ( similar delivery method for both groups)Both patient groups were prescribed ibuprofen 400mg three times a day.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
The ethical committee at Islamic International Dental Hospital
Street address
7th avenue G7/4 , Islamabad
City
Islamabad
Postal code
25000
Approval date
2023-08-04, 1402/05/13
Ethics committee reference number
IIDC/08/023
Health conditions studied
1
Description of health condition studied
non vital asymptomatic teeth with necrotic pulp that require endodontic treatment
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
post operative pain
Timepoint
24, 48, 72 hours after procedure
Method of measurement
visual analog scale.
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: group A ibuprofen/dexamethasone infiltration. for this group all participants were given a single infiltration of 0.5 mg dexamethasone at the periapical tissue region. After the completion of root canal therapy
Category
Treatment - Drugs
2
Description
Control group: group B. for this group of participants a single infiltration of 0.5 mg of normal saline ( placebo) was given at the periapical region after completion of root canal therapy
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Operative Dentistry Department of Islamic International Dental Hospital - Islamabad, Pakistan
Full name of responsible person
Dr. ABID HUSSAIN
Street address
St. 41 7th Ave, G-7/4 G 7/4 G-7, Islamabad, Islamabad Capital Territory
City
Islamabad
Postal code
P34H+5Q9,
Phone
+92 51 8108795
Email
asimovtm@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Islamic International Dental Hospital
Full name of responsible person
Dr. ABID HUSSAIN
Street address
St. 41 7th Ave, G-7/4 G 7/4 G-7, Islamabad, Islamabad Capital Territory
City
ISLAMABAD
Postal code
P34H+5Q9
Phone
+92 51 8108795
Email
qazii.abid@hotmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Islamic International Dental Hospital
Proportion provided by this source
5
Public or private sector
Private
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
Islamic International Dental Hospital
Full name of responsible person
Dr. ABID HUSSAIN
Position
RESIDENT
Latest degree
Bachelor
Other areas of specialty/work
Dentistry
Street address
St. 41 7th Ave, G-7/4 G 7/4 G-7, Islamabad, Islamabad Capital Territory
City
ISLAMABAD
Province
FEDERAL CAPITAL
Postal code
P34H+5Q9
Phone
+92 51 8108795
Email
qazii.abid@hotmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ayub medical & dental college
Full name of responsible person
Dr. Asim Qureshi
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Riaz house hill street opposite hotel one
City
Abbottabad
Province
khyber pakhtunkhwa
Postal code
224400
Phone
+92 992 406585
Email
asimovtm@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Islamic International Dental Hospital
Full name of responsible person
Dr. ABID HUSSAIN
Position
RESIDENT
Latest degree
Bachelor
Other areas of specialty/work
Dentistry
Street address
St. 41 7th Ave, G-7/4 G 7/4 G-7, Islamabad, Islamabad Capital Territory
City
ISLAMABAD
Province
FEDERAL CAPITAL
Postal code
P34H+5Q9
Phone
+92 51 8108795
Email
qazii.abid@hotmail.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
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Not applicable
Title and more details about the data/document
collective data of all participants data ( data sheet) will be made available. assuring that the data provided is de identifed. .
When the data will become available and for how long
once it has been published. always availably on demand
To whom data/document is available
any researcher, that contacts the corresponding author for data with vailed justification
Under which criteria data/document could be used
For researcher only . But complete data sheets will be provided where authors seems the reason is justified.
From where data/document is obtainable
upon contact with the corresponding researcher. by mail
asim@ayubmed.edu.pk. Dr asim qureshi
What processes are involved for a request to access data/document
a formal request to the author with proof of research activity on the same topic.