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The study will be two parallel group, triple blinded randomized controlled clinical trial that based on CONSORT (consolidated standards of reporting trials) guideline .The selected participants according to inclusion and exclusion criteria will be randomly allocated in two groups using (Research Randomizer Program) .
Blinding All participants don't know the type of received restorative material (ACTIVA Kids or High -viscosity GI restorative material) and the outcome will be evaluated by a examiner other than operator who doesn't know the type of received restorative material also.
Study setting The study will be performed at pediatric Department and Dental Public Health Department of Faculty of Dentistry, Ain Shams University, and at the institute of Graduate Studies and Research, Ain Shams University.
Sample size: 60 participants Recruitment/Setting The all participants of this study have been selected after complete clinical examination has been done with full medical and dental history , history of medications and history of hospitalization. In patients who receive dental treatment as an usual care in clinics of Pediatric Dentistry and Dental Public Health Department at faculty of dentistry, Ain-Shams University.
Informed consent designed to include all data about dental procedures in this study and clear more details about time consuming in the procedure and follow up visits, used materials and adverse event of this procedure . All participants have the wright to withdraw from this study at any time .The consent will be assigned from each patient by the patient's parents or guardians after explanation of the study.
The full mouth rehabilitation will be performed by postgraduate student registered at the master Degree at the Pediatric Dentistry and Dental Public Health Department Faculty of Dentistry, Ain- Shams University All subjects receive instructions on oral health, particularly in relation to oral hygiene and sugar consumption
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group I | Active Comparator | Group I : will consist of 30 teeth that will be restored by high-viscosity glass ionomer (Fuji IX Extra) with ART approach |
|
| Group II | Active Comparator | Group II : will consist of 30 teeth that will be restored by bioactive restorative material (ACTIVA KIDS bioactive restorative material) with ART approach. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fuji IX EXTRA | Drug | High-viscosity glass ionomer (Fuji IX EXTRA) |
|
| Measure | Description | Time Frame |
|---|---|---|
| the Success Rate of ACTIVA BIOACTIVE and Fuji IX Extra GIC With ART in Class I Carious Cavity of Primary Teeth | Using Atraumatic restorative treatment criteria from 0 to 9, The restorations were considered to have survived when given scores 0,1, or 7 and to have failed with scores 2,3,4,8, while those scores 5,6 were considered to be unrelated to success and failure. | 12 Month |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Amr Mahmoud Abd EL Aziz | Professor of Pediatric Dentistry and Dental Public Health Department -ASU | Study Chair |
| Reham Khaled Abou El Fadl | Lecturer of Pediatric Dentistry and Dental Public Health Department -ASU | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Marina Fakhry Fahmy Saad | Cairo | Egypt |
Excluded (n = 40)
- Tooth not meeting inclusion criteria
Recruitment of patients was done from a convenient sample of children who attended the outpatient clinic of Pediatric Dentistry and Dental Public Health Department, Faculty of Dentistry, Ain-Shams University seeking dental treatment, or for regular checkups. All patients who met the eligibility criteria of the study were invited to participate. Pre-operative comprehensive clinical examination was performed and caries experience was determined using dmft index
| ID | Title | Description |
|---|---|---|
| FG000 | Fuji IX Extra Group I | Group I: will consist of 35 teeth that will be restored by high-viscosity glass ionomer (Fuji IX Extra) with an ART approach Fuji IX EXTRA: High-viscosity glass ionomer (Fuji IX EXTRA) |
| FG001 | Bioactive Composite Group II | Group II: will consist of 35 teeth that will be restored by bioactive restorative material (ACTIVA KIDS bioactive restorative material) with ART approach. ACTIVA KIDS bioactive restorative material: Modified composite (ACTIVA KIDS) |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
carious primary molars limited to occlusal table (class I cavity) in 4-8 yrs old patients
| ID | Title | Description |
|---|---|---|
| BG000 | Group I | Group I: will consist of 35 teeth that will be restored by high-viscosity glass ionomer (Fuji IX Extra) with ART approach Fuji IX EXTRA: High-viscosity glass ionomer (Fuji IX EXTRA) |
| BG001 | Group II |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | not meeting the inclusion criteria |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | the Success Rate of ACTIVA BIOACTIVE and Fuji IX Extra GIC With ART in Class I Carious Cavity of Primary Teeth | Using Atraumatic restorative treatment criteria from 0 to 9, The restorations were considered to have survived when given scores 0,1, or 7 and to have failed with scores 2,3,4,8, while those scores 5,6 were considered to be unrelated to success and failure. | Posted | Number | primary molars | 12 Month | primary molars | primary molars |
|
3 months, 6 months,1 year
failure of restorations in participated primary molars. (non-serious adverse event)
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Fuji IX EXTRA GIC With ART | Group I : will consist of 35 teeth that will be restored by high-viscosity glass ionomer (Fuji IX Extra) with ART approach Fuji IX EXTRA: High-viscosity glass ionomer (Fuji IX EXTRA) |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| failure of restoration | Product Issues | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Marina Fakhry assistant lecturer of pediatric dentistry | Faculty of dentistry, Ain Shams University | 01273731722 | +02 | Dr.marina.fakhry@gmail.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Feb 14, 2018 | Jan 2, 2022 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D003731 | Dental Caries |
| ID | Term |
|---|---|
| D017001 | Tooth Demineralization |
| D014076 | Tooth Diseases |
| D009057 | Stomatognathic Diseases |
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| ACTIVA KIDS bioactive restorative material | Drug | Modified composite (ACTIVA KIDS) |
|
|
Group II: will consist of 35 teeth that will be restored by bioactive restorative material (ACTIVA KIDS bioactive restorative material) with ART approach.
ACTIVA KIDS bioactive restorative material: Modified composite (ACTIVA KIDS)
| BG002 | Total | Total of all reporting groups |
| primary molars |
|
| Mean |
| Standard Deviation |
| years |
| Participants |
|
| Sex: Female, Male |
| Count of Participants | Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants | Participants |
|
Group II: will consist of 35 teeth that will be restored by bioactive restorative material (ACTIVA KIDS bioactive restorative material) with ART approach.
ACTIVA KIDS bioactive restorative material: Modified composite (ACTIVA KIDS)
|
|
|
| 0 |
| 35 |
| 0 |
| 35 |
| 4 |
| 35 |
| EG001 | ACTIVA KIDS With ART | Group II : will consist of 35 teeth that will be restored by bioactive restorative material (ACTIVA KIDS bioactive restorative material) with ART approach. ACTIVA KIDS bioactive restorative material: Modified composite (ACTIVA KIDS) | 0 | 35 | 0 | 35 | 7 | 35 |
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