Dental Caries
Conditions
Keywords
Bioactive Restorative Material , ART
Brief summary
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) .
Detailed description
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
Interventions
DRUGFuji IX EXTRA
High-viscosity glass ionomer (Fuji IX EXTRA)
DRUGACTIVA KIDS bioactive restorative material
Modified composite (ACTIVA KIDS)
Sponsors
Marina F Fahmy, MD
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
4 Years to 8 Years
Healthy volunteers
Yes
Inclusion criteria
1. Children aged from 4 to 8 years old, in good general health 2. Children classified as class 3 or 4 based on Frankel et al. classification. (26) 3. The children have at least one primary molar with class I carious lesion. 4. Asymptomatic teeth (without spontaneous pain)
Exclusion criteria
1. Medically compromised patient 2. Presence of pulp exposure, pain, mobility 3. Presence of swelling, abscess or fistula near the tooth 4. Not accessible carious lesion to hand instruments
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| the Success Rate of ACTIVA BIOACTIVE and Fuji IX Extra GIC With ART in Class I Carious Cavity of Primary Teeth | 12 Month | 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. |
Countries
Egypt
Participant flow
Recruitment details
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
Pre-assignment details
Excluded (n = 40) \- Tooth not meeting inclusion criteria
Participants by arm
| Arm | Count |
|---|---|
| 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) | 35 |
| 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) | 35 |
| 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) | 35 |
| 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) | 35 |
| Total | 140 |
Baseline characteristics
| Characteristic | Group II | Total | Group I |
|---|---|---|---|
| Age, Continuous | 5.9 years STANDARD_DEVIATION 1.49 | 5.7 years STANDARD_DEVIATION 1.4 | 5.6 years STANDARD_DEVIATION 1.49 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 35 Participants | 70 Participants | 35 Participants |
| Race (NIH/OMB) White | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Female | 21 Participants | 36 Participants | 15 Participants |
| Sex: Female, Male Male | 14 Participants | 34 Participants | 20 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 35 | 0 / 35 |
| other Total, other adverse events | 4 / 35 | 7 / 35 |
| serious Total, serious adverse events | 0 / 35 | 0 / 35 |
Outcome results
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.
Time frame: 12 Month
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Fuji IX Extra GIC With ART | the Success Rate of ACTIVA BIOACTIVE and Fuji IX Extra GIC With ART in Class I Carious Cavity of Primary Teeth | success rate after 3 Months | 30 primary molars |
| Fuji IX Extra GIC With ART | the Success Rate of ACTIVA BIOACTIVE and Fuji IX Extra GIC With ART in Class I Carious Cavity of Primary Teeth | success rate after 6 months | 28 primary molars |
| Fuji IX Extra GIC With ART | the Success Rate of ACTIVA BIOACTIVE and Fuji IX Extra GIC With ART in Class I Carious Cavity of Primary Teeth | success rate after 12 months | 26 primary molars |
| ACTIVA KIDS With ART | the Success Rate of ACTIVA BIOACTIVE and Fuji IX Extra GIC With ART in Class I Carious Cavity of Primary Teeth | success rate after 3 Months | 32 primary molars |
| ACTIVA KIDS With ART | the Success Rate of ACTIVA BIOACTIVE and Fuji IX Extra GIC With ART in Class I Carious Cavity of Primary Teeth | success rate after 6 months | 30 primary molars |
| ACTIVA KIDS With ART | the Success Rate of ACTIVA BIOACTIVE and Fuji IX Extra GIC With ART in Class I Carious Cavity of Primary Teeth | success rate after 12 months | 25 primary molars |
p-value: 0.478t-test, 2 sided