The object of this study is to compare the effect of calcium hydroxide and nano calcium hydroxide 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 that will perform in shiraz dental school, 24 patients would be selected to be treated with two different medicine for regeneration of necrotic pulp in the way that patients, practitioners, and evaluators are blind
Participants/Inclusion and exclusion criteria
Patients with a restorable tooth with necrotic pulp and open apices, with or without radiographic evidence of periapical lesion, and a negative response to vitality tests without any medical history of systemic conditions will be included in the study.
Teeth having periodontal disease, internal o external resorption, and fracture in the root will exclude from the study
Intervention groups
Intervention group: Nano calcium hydroxide paste with a creamy consistency will use for disinfection of root canal in the regeneration of a tooth with necrotic pulp.
Control group: Calcium hydroxide paste with a creamy consistency will use for disinfection of root canal in the regeneration of a tooth with necrotic pulp.
Medicaments of both groups will deliver into the root canal at the first appointment and will irrigate from the root canal after three weeks. the cervical portion of the root will restore with MTA as a sealing material
Comparison of the Effect of Calcium Hydroxide and Nano Calcium Hydroxide on Regeneration of Immature Permanent Teeth : A Clinical Pilot Study
Public title
Effect of Nano Calcium Hydroxide in tooth pulp Regeneration
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Non-Vital Permanent teeth with Open Apex (file size number equal or more than 60)
With or Without Radiographic Radiolucency
Negative Response to Pulp Vitality Test
Restorable Tooth
No Systemic Conditions
Patients’ age between 6-16 years old
Exclusion criteria:
With Radiographic Evidence of Internal or External Resorption
With Root Fractures
With Periodontal Involvement
Those Who Do Not Cooperate
Age
From 6 years old to 16 years old
Gender
Both
Phase
2-3
Groups that have been masked
Participant
Care provider
Outcome assessor
Data analyser
Sample size
Target sample size:
24
Randomization (investigator's opinion)
Randomized
Randomization description
Individual 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 Pulp revitalization with calcium hydroxide and nano calcium hydroxide paste.
Blinding (investigator's opinion)
Triple blinded
Blinding description
Calcium hydroxide and nano calcium hydroxide pastes will give to the practitioner in a similar volume, consistency, and color, as well as a similar container.
Participants ( patients) will not be aware of the type of material used in the therapy as same as the evaluators of the treatment results. The researcher is the only one who knows which medicament has been 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 science
Street address
Shiraz Dental School, Ghasrodasht Street, Shiraz
City
Shiraz
Province
Fars
Postal code
7195615878
Approval date
2021-05-26, 1400/03/05
Ethics committee reference number
IR.SUMS.DENTAL.REC.1400.029
Health conditions studied
1
Description of health condition studied
Immature tooth pulp necrosis
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Pulp revitalization
Timepoint
Evaluation of pulp revitalization would perform in 3, 6, and 9 month after treatment.
Method of measurement
Cold test and electrical pulp test for evaluating pulp revitalization
2
Description
Root dentin diameter change
Timepoint
Evaluation of changes in root dentin diameter would perform in 3, 6, and 9 month after treatment.
Method of measurement
The difference between the external root thickness and the width of the pulpal area of the canal will evaluate radiographically.
3
Description
Root length chages
Timepoint
Evaluation of changes in root length would perform in 3, 6, and 9 month after treatment.
Method of measurement
Distance between Cemento-Enamel-Junction on the mesial portion and the mesial and distal point at the end of the apex will evaluate radiographically.
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Regeneration treatment of dental pulp would perform using nano-calcium hydroxide paste (Polymer and Petrochemical Institute, Tehran, Iran) with a creamy consistency obtained by a combination of nano-calcium hydroxide powder and 0.9% saline in three to one ratio, According to the American Association of Endodontics protocol.
Category
Treatment - Drugs
2
Description
Control group: Regeneration treatment of dental pulp would perform using calcium hydroxide paste (Merck, Darmstadt, Germany) with a creamy consistency obtained by a combination of calcium hydroxide powder and 0.9% saline in three to one ratio, According to the American Association of Endodontics protocol.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Shiraz Dental School
Full name of responsible person
Dr Safoora Sahebi
Street address
Shiraz Dental School, Ghasrodasht Street, Shiraz
City
Shiraz
Province
Fars
Postal code
7196515878
Phone
+98 71 3193 3626
Email
sahebisafoora@gmail.com
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
7195615878
Phone
+98 71 7282 3235
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 Safoora Sahebi
Position
Associated Professor of Endodontics, Shiraz University of Medical Science
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Shiraz Dental School, Ghasrodasht Street, Shiraz
City
Shiraz
Province
Fars
Postal code
7195615878
Phone
+98 71 3194 3626
Email
sahebisafoora@gmail.com
Person responsible for scientific inquiries
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 Science
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Shiraz Dental School, Ghasrodasht Street, Shiraz
City
Shiraz
Province
Fars
Postal code
7195615878
Phone
+98 71 3194 3626
Email
sahebisafoora@gmail.com
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 Science
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Shiraz Dental School, Ghasrodasht Street, Shiraz
City
Shiraz
Province
Fars
Postal code
7195615878
Phone
+98 71 3194 3626
Email
sahebisafoora@gmail.com
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 results of the study consist of clinical and radiographic findings of participants due to the kind of materials which were used.
When the data will become available and for how long
6 months after publication
To whom data/document is available
there is no limit.
Under which criteria data/document could be used
with referencing of the article
From where data/document is obtainable
the corresponding author
What processes are involved for a request to access data/document
the written request should be sent through an email to the corresponding author - data will give in one month after the permission of all authors