Comparison of clinical efficacy of primary anterior restoration with two different types of post systems with reconstruction of severely damaged teeth in3-5 years old children
Specifying the clinical success of anterior deciduous repairing through two systems of customized glass fiber post and composite post postal systems in dental restoration with extensive destruction in patients referred to the specialist Pediatric Clinic of the Faculty of Dentistry Islamic Azad University of Medical Sciences, Tehran in 2020.
Design
This was a clinical trial study with a parallel, double-blind group, randomized for 32 patients with 64 samples, which used coins in order to determine care quadrants and the opening envelops for treating each tooth.
Settings and conduct
Samples will be selected from 3-5-year-old children who go to the Pediatric Clinic of the School of Dentistry of the Islamic Azad University of Medical Sciences in Tehran
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Cooperator on the basis Frankel I and II
Mentally and physically healthy children
The maxillary anterior deciduous tooth in which its pulp was involved and had similar caries on both sides and more than two-thirds of its root length remained without analysis.
At least 1 mm of the supragingival structure without caries
Exclusion criteria:
Children with mental and physical disorders
History of trauma
Existence of destructive oral habits
Teeth with hypoplasia
poor oral hygiene
Intervention groups
The first group made use of customized glass fiber post as a post so that 3 mm of it remained inside the canal, and the remaining was placed out of the canal as the core.
The second group used composite as a post. After applying bonding in this group, one layer of flow composite was placed inside the canal. Then the micro-hybrid composite was condensed inside the canal and consequently placed as a layer up to a height of 3 mm.
Comparison of clinical efficacy of primary anterior restoration with two different types of post systems with reconstruction of severely damaged teeth in3-5 years old children
Public title
Comparison of clinical efficacy of primary anterior restoration with two different types of post systems in severely damaged teeth
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Cooperator on the basis Frankel I and II
Mentally and physically healthy children who were not involved in systemic disease
The maxillary anterior deciduous tooth which its pulp was involved
The maxillary anterior deciduous tooth with similar caries on both sides
A tooth with more than two-thirds of its root length without physiological or pathological analysis (internal and external)
At least 1 mm of the supragingival structure without caries
Exclusion criteria:
History of trauma
Existence of destructive oral habits
Teeth with hypoplasia
Children involved in poor oral hygiene
Age
From 3 years old to 5 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Outcome assessor
Sample size
Target sample size:
32
More than 1 sample in each individual
Number of samples in each individual:
2
-
Randomization (investigator's opinion)
Randomized
Randomization description
The teeth of each patient were randomly selected to be repaired through a composite post or customized glass fiber post. The randomization method was that the side that started first was determined by a coin, and then it was decided on the treatment when opening a closed envelope.
Blinding (investigator's opinion)
Double blinded
Blinding description
The consequence assessors were different from the therapist, and the assessor was not aware of the information of patients and the type of treatment taken on the teeth. The patient was not also informed of the type of treatment on the teeth.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Islamic Azad university of medical sciences,dental school
Street address
No.9, Neyestan 9th alley, Pasdaran Ave.
City
Tehran
Province
Tehran
Postal code
1946853314
Approval date
2020-05-27, 1399/03/07
Ethics committee reference number
IR.IAU.DENTAL.REC.1399.031
Health conditions studied
1
Description of health condition studied
Primary dental caries
ICD-10 code
K02.63
ICD-10 code description
Dental caries on smooth surface penetrating into pulp
Primary outcomes
1
Description
Surface texture
Timepoint
3,6 months after treatment
Method of measurement
Observation
2
Description
Marginal integrity
Timepoint
3,6 months after treatment
Method of measurement
Examination with dental explorer
3
Description
Marginal discoloration
Timepoint
3,6 months after treatment
Method of measurement
Observation
4
Description
Secondary caries
Timepoint
3,6 months after treatment
Method of measurement
Radiography
5
Description
Restoration failure
Timepoint
3,6 months after treatment
Method of measurement
Observation
6
Description
Retention
Timepoint
3,6 months after treatment
Method of measurement
Observation
7
Description
Gingival health
Timepoint
3,6 months after treatment
Method of measurement
Probing
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: All treatments (pulpectomy and repair) were carried out by a therapist. In the first session of treatment, adequate anesthesia was imposed on teeth. Mechanical and chemical measures were prepared by rotary files (easyinsmile international cord-NITI Engine File, USA) (usually up to file number 30) and solutions such as normal saline. In the following, the canals were dried by paper points. Root canals would be filled by metapex paste (Metapex, META, Korea). In the second session, from the beginning of the canal, it was emptied by a fissure bar connected to angle number 008 (Tizkavan Company, Tehran, Iran) to create a post space of 4 mm. After cleaning and drying the layer post space, a 1 mm thick layer of optical glass ionomer cement (Willmann & Pein- Glass liner,Germany) was replaced (on metapex). Then 3 mm post space was standardized for all samples. After cleaning and rinsing 3 mm at the beginning of the canal, 1-2 second pure air was applied to dry the canal, and then bonding was carried out through the method of self-etching according to the factory instructions. 1-2 bonding drop (Bisco-ALL-BOND UNIVERSAL, USA) was rubbed in the canal in the form of two separate layers, and its additions were removed by pure air. Then, customized strip-shaped fibers (Angelus,Brazil) of customized glass fiber post was applied in accordance with factory instructions. 1-2 bonding drop (Bisco-ALL-BOND UNIVERSAL, USA) was rubbed in the canal in the form of two separate layers, and its additions were removed by pure air.Then, customized strip-shaped fibers (Angelus,Brazil) of customized glass fiber post was used in accordance with factory instructions. So that, 3 mm of it remained inside the canal, and the remaining (2mm) was placed outside of the canal as a core. Some 5 mm strip-shaped fibers were packed inside the canal along with a thin layer of resinous cement (Bisco-DOU-LINK UNIVERSAL, USA), until the space inside the channel was completely filled. After that, it was cured for 20 seconds by a dental light curing device with a power of 800 mw / cm2. To rebuild the crown, the enamel was etched for 15 seconds by 35% phosphoric acid (Scotchbond ™ Etchant, 3M ESPE, MN, USA). Bonding was applied in the same way as addressed above and after 10 seconds of curing, and the crown was restored by microhybrid composite (Bisco-AELITE ALL / PURPOSE BODY, USA) and the method of incremental.
Category
Treatment - Other
2
Description
Control group:All treatments (pulpectomy and repair) were carried out by a therapist. In the first session of treatment, adequate anesthesia was imposed on teeth. Mechanical and chemical measures were prepared by rotary files (easyinsmile international cord-NITI Engine File, USA) (usually up to file number 30) and solutions such as normal saline. In the following, the canals were dried by paper points. Root canals would be filled by metapex paste (Metapex, META, Korea). In the second session, from the beginning of the canal, it was emptied by a fissure bar connected to angle number 008 (Tizkavan Company, Tehran, Iran) to create a post space of 4 mm. After cleaning and drying the layer post space, a 1 mm thick layer of optical glass ionomer cement (Willmann & Pein- Glass liner,Germany) was replaced (on metapex). Then 3 mm post space was standardized for all samples. After cleaning and rinsing 3 mm at the beginning of the canal, 1-2 second pure air was applied to dry the canal, and then bonding was carried out through the method of self-etching according to the factory instructions. 1-2 bonding drop (Bisco-ALL-BOND UNIVERSAL, USA) was rubbed in the canal in the form of two separate layers, and its additions were removed by pure air. Then, customized strip-shaped fibers (Angelus,Brazil) of customized glass fiber post was applied in accordance with factory instructions. 1-2 bonding drop (Bisco-ALL-BOND UNIVERSAL, USA) was rubbed in the canal in the form of two separate layers, and its additions were removed by pure air.In the following, bonding was applied by the self-etching method based on the factory instructions. 1-2 bonding drop (Bisco-ALL-BOND UNIVERSAL, USA) was rubbed in the canal in the form of two separate layers, and its additions were removed by pure air. The composite was then utilized as a post (as a control group). In this group, after applying the bonding in the same mentioned method and its curing for 20-30 seconds (based on factory instructions), one layer of flow composites (Bisco- AELITEFLO /AELITEFLO LV,USA) was placed inside the canal and was layered up to a height of 3 mm. The crown rebuild was performed by microhybrid composite
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Pediatric dentistry department of Islamic Azad university of medical sciences, Tehran branch
Full name of responsible person
Nahid Askarizadeh
Street address
No.9, 9th Neyestan alley,Pasdaran Ave
City
Tehran
Province
Tehran
Postal code
1946853314
Phone
+98 21 2258 0966
Email
nahidaskarizadeh@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Islamic Azad University
Full name of responsible person
Nahid Askarizadeh
Street address
No9, 9th Neyestan alley,Pasdaran Ave.
City
Tehran
Province
Tehran
Postal code
1946853314
Phone
+98 21 2258 0966
Email
nahidaskarizadeh@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Islamic Azad University
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
Other
Person responsible for general inquiries
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Faezeh Abedi
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Dentistry
Street address
No18, Noshad dead-end, Gordafrid Ave, North Kargar Ave