Trial Outcomes & Findings for Fluoride Release,Compressive Strength and Clinical Performance of a Bioactive Restorative Material in ART (NCT NCT03788616)
NCT ID: NCT03788616
Last Updated: 2023-01-19
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
110 participants
Primary outcome timeframe
12 Month
Results posted on
2023-01-19
Participant Flow
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
Excluded (n = 40) \- Tooth not meeting inclusion criteria
Unit of analysis: primary molars
Participant milestones
| Measure |
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)
|
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)
|
|---|---|---|
|
Overall Study
STARTED
|
35 35
|
35 35
|
|
Overall Study
COMPLETED
|
30 30
|
32 32
|
|
Overall Study
NOT COMPLETED
|
5 5
|
3 3
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
not meeting the inclusion criteria
Baseline characteristics by cohort
| Measure |
Group I
n=35 primary molars
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)
|
Group II
n=35 primary molars
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)
|
Total
n=70 primary molars
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
5.6 years
STANDARD_DEVIATION 1.49 • n=5 Participants • not meeting the inclusion criteria
|
5.9 years
STANDARD_DEVIATION 1.49 • n=7 Participants • not meeting the inclusion criteria
|
5.7 years
STANDARD_DEVIATION 1.4 • n=5 Participants • not meeting the inclusion criteria
|
|
Sex: Female, Male
Female
|
15 Participants
n=5 Participants • 1. not meeting the inclusion criteria 2. not complete the treatment plane
|
21 Participants
n=7 Participants • 1. not meeting the inclusion criteria 2. not complete the treatment plane
|
36 Participants
n=5 Participants • 1. not meeting the inclusion criteria 2. not complete the treatment plane
|
|
Sex: Female, Male
Male
|
20 Participants
n=5 Participants • 1. not meeting the inclusion criteria 2. not complete the treatment plane
|
14 Participants
n=7 Participants • 1. not meeting the inclusion criteria 2. not complete the treatment plane
|
34 Participants
n=5 Participants • 1. not meeting the inclusion criteria 2. not complete the treatment plane
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
35 Participants
n=5 Participants
|
35 Participants
n=7 Participants
|
70 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 12 MonthUsing 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.
Outcome measures
| Measure |
Fuji IX Extra GIC With ART
n=35 primary molars
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)
|
ACTIVA KIDS With ART
n=35 primary molars
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)
|
|---|---|---|
|
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
|
32 primary molars
|
|
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
|
30 primary molars
|
|
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
|
25 primary molars
|
Adverse Events
Fuji IX EXTRA GIC With ART
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
ACTIVA KIDS With ART
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Fuji IX EXTRA GIC With ART
n=35 participants at risk
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)
|
ACTIVA KIDS With ART
n=35 participants at risk
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)
|
|---|---|---|
|
Product Issues
failure of restoration
|
11.4%
4/35 • Number of events 4 • 3 months, 6 months,1 year
failure of restorations in participated primary molars. (non-serious adverse event)
|
20.0%
7/35 • Number of events 7 • 3 months, 6 months,1 year
failure of restorations in participated primary molars. (non-serious adverse event)
|
Additional Information
Dr. Marina Fakhry assistant lecturer of pediatric dentistry
Faculty of dentistry, Ain Shams University
Phone: 01273731722
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place