Comparison of the Effect of Double Antibiotic Paste Alone or in Combination with Metformin on Regeneration of Non-Vital Immature Teeth: A Pilot Clinical Study
the objective of this study is to compare the effect of Double Antibiotic Paste alone or in combination with Metformin on the Regeneration of nonvital immature teeth
Design
A randomized clinical trial will be performed on 24 patients that were randomly divided as a control and a parallel experimental group, triple blinded that were randomized by random.org software.
Settings and conduct
In this study, in Shiraz Dental School, 24 patients would be selected in order to be treated with two different regeneration medicine in the way that patients, the practitioner, and observers are blind.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Nonvital permanent restorable teeth with open apices with or without radiographic evidence of periapical lesions, negative response to vitality tests, and the participant gave no contributory systemic medical history.
Exclusion criteria:
Severe Periodontal Disease, Internal or External Root Resorption
Intervention groups
Intervention Group: Using the combination of Metformin 500 mg (Abidi co.) and Double Antibiotic Paste (DAP) as a disinfectant in the Regeneration of Nonvital Pulp;
Control group: use of the DAP alone as a disinfectant in the Regeneration of Necrotic Pulp as a suggested protocol.
DAP is a combination of 250 mg Metronidazole( Kosar co.) and 500 mg Ciprofloxacin(Tolidaru co.) and has been proved to have an antibacterial effect and is used in the first session of Regeneration protocol and washed out three weeks later, the cervical segment of root canal system would be sealed with MTA (Angelus, Londrina, PR, Brazil).
Comparison of the Effect of Double Antibiotic Paste Alone or in Combination with Metformin on Regeneration of Non-Vital Immature Teeth: A Pilot Clinical Study
Public title
Effect of Metformin Combination with Double Antibiotic Paste (DAP) in Tooth Pulp Regeneration
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Non- Vital Permanent Teeth with Open Apex(File size equal or more than 60)
With or without Radiographic Radiolucency
Negative Response to Pulp Vitality Test
Restorable Tooth
No Systemic Conditions
Exclusion criteria:
Severe periodontal disease,
Internal and external root resorption
Age
From 7 years old to 11 years old
Gender
Both
Phase
2-3
Groups that have been masked
Participant
Care provider
Outcome assessor
Data analyser
Data and Safety Monitoring Board
Sample size
Target sample size:
24
Randomization (investigator's opinion)
Randomized
Randomization description
Block Randomization Method was used for the Patient's Allocation into two groups with a 1:1 Ratio by RANDOM.ORG Software.
Participants were divided into two Groups of Double Antibiotic Paste Revascularization techniques with and without Metformin.
Blinding (investigator's opinion)
Triple blinded
Blinding description
The Double Antibiotic pastes with the same Color, Consistency, and Volume are delivered in the same Container to the Practitioner.
Participants ( patients) have no idea about the materials that were used for them.
Observers have no Idea about the materials which are used for the Patients.
The Researcher is the only one who knows about suggested Materials which is used for each Patient and leads the Research.
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
Shiraz Dental School , GHasrdasht St..reet
City
Shiraz
Province
Fars
Postal code
71956-15878
Approval date
2020-01-05, 1398/10/15
Ethics committee reference number
IR.SUMS.DENTAL.REC.1398.139
Health conditions studied
1
Description of health condition studied
Tooth Pulp Necrosis
ICD-10 code
-
ICD-10 code description
-
Primary outcomes
1
Description
pulp revitalization
Timepoint
Before intervention and patient follow up for 3 and 12 months after intervention
Method of measurement
Clinical And Radiographic Assessment
2
Description
Changes in diameter of root dentin with the regenerated tissues
Timepoint
Before intervention and patient follow up for 3 and 12 months after intervention
Method of measurement
Clinical And Radiographic Assessment
3
Description
Changes the length of root with the regenerated tissues
Timepoint
Before intervention and patient follow up for 3 and 12 months after intervention
Method of measurement
Clinical And Radiographic Assessment
Secondary outcomes
empty
Intervention groups
1
Description
Control group: the tooth is anesthetized, isolated, and accessed. After determining the working length, the canals should be copiously irrigated with NAOCL 1.5%followed by 17% EDTA. Canals were dried with sterile paper points and double antibiotic paste (DAP) as a mixture of Ciprofloxacin 500 mg (Tolidaru Co.) and Metronidazole 250mg (Kosar Co.) at the concentration of 1mg/ml is placed into the canals for 3-4weeks. In the second appointment, canals should be irrigated with 17%EDTA, and after the creation of bleeding with a No.25 file, on top of the coagulum, about 3 mm of MTA is then placed.
Category
Treatment - Drugs
2
Description
Intervention group: the tooth is anesthetized, isolated, and accessed. After determining the working length, the canals should be copiously irrigated with NAOCL 1.5%followed by 17% EDTA. Canals were dried with sterile paper points and double antibiotic paste (DAP) as a mixture of Ciprofloxacin 500 mg (Tolidaru Co.) and Metronidazole 250mg (Kosar Co.) Adding Metformin 500mg (Abidi Co.) with the same volume of antibiotics at the concentration of 1mg/ml is placed into the canals for 3-4weeks. In the second appointment, canals should be irrigated with 17%EDTA, and after the creation of bleeding with No.25 file, on top of the coagulum, about 3 mm of MTA is then placed.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Shiraz Dental School
Full name of responsible person
Dr. Fariborz Moazami
Street address
Shiraz Dental School , Ghasrdasht street , Shiraz
City
Shiraz
Province
Fars
Postal code
71965-15878
Phone
+98 71 3626 3193
Email
fmoazzami@sums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Dr. Abbas Rezaianzade
Street address
Shiraz medical School, Zand street
City
shiraz
Province
Fars
Postal code
71956- 15878
Phone
+98 71 3235 7282
Fax
+98 71 3212 2430
Email
rezaiana@sums.ac.ir
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 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
Shiraz University of Medical Sciences
Full name of responsible person
Dr. Fariborz Moazami
Position
Full Professor of Endodontics , Shiraz University of Medical Sciences
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Shiraz dental School, Ghasrdasht St.
City
Shiraz
Province
Fars
Postal code
۷۱۹۵۶-۱۵۸۷۸
Phone
+98 71 3626 3193
Email
fmoazzami@sums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Dr, Fariborz Moazmi
Position
Full Professor of Endodontics, Shiraz University of Medical Sciences
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Shiraz dental school , Ghasrdasht St.
City
Shiraz
Province
Fars
Postal code
71956-15878
Phone
+98 71 3626 3194
Email
fmoazzami@sums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Dr. Safoora Sahebi
Position
Associated Professor of Endodontics, Shiraz University of Medical Sciences
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Shiraz dental school , Ghasrdasht St.
City
Shiraz
Province
Fars
Postal code
71956-15878
Phone
+98 71 3626 3194
Email
sahebis@sums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is 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
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
The result of study consist of clinical and radiographic findings of participants due to the kind of materials which was used
When the data will become available and for how long
6 months after publishing
To whom data/document is available
No limit
Under which criteria data/document could be used
With referencing of the article
From where data/document is obtainable
Corresponding author
What processes are involved for a request to access data/document
Written request by email for corresponding author. One month after the permission of all authors