Fluoride Release,Compressive Strength and Clinical Performance of a Bioactive Restorative Material in ART
Primary Purpose
Dental Caries
Status
Completed
Phase
Phase 3
Locations
Egypt
Study Type
Interventional
Intervention
Fuji IX EXTRA
ACTIVA KIDS bioactive restorative material
Sponsored by
About this trial
This is an interventional treatment trial for Dental Caries focused on measuring Bioactive Restorative Material , ART
Eligibility Criteria
Inclusion Criteria:
- Children aged from 4 to 8 years old, in good general health
- Children classified as class 3 or 4 based on Frankel et al. classification. (26)
- The children have at least one primary molar with class I carious lesion.
- Asymptomatic teeth (without spontaneous pain)
Exclusion Criteria:
- Medically compromised patient
- Presence of pulp exposure, pain, mobility
- Presence of swelling, abscess or fistula near the tooth
- Not accessible carious lesion to hand instruments
Sites / Locations
- Marina Fakhry Fahmy Saad
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Group I
Group II
Arm Description
Group I : will consist of 30 teeth that will be restored by high-viscosity glass ionomer (Fuji IX Extra) with ART approach
Group II : will consist of 30 teeth that will be restored by bioactive restorative material (ACTIVA KIDS bioactive restorative material) with ART approach.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT03788616
First Posted
December 14, 2018
Last Updated
December 22, 2022
Sponsor
Marina F Fahmy, MD
1. Study Identification
Unique Protocol Identification Number
NCT03788616
Brief Title
Fluoride Release,Compressive Strength and Clinical Performance of a Bioactive Restorative Material in ART
Official Title
Evaluation of Fluoride Release and Compressive Strength of a Bioactive Restorative Material and Its Clinical Performance in Atraumatic Restorative Treatment in Primary Molars (An in Vitro Study & A Randomized Controlled Trial )
Study Type
Interventional
2. Study Status
Record Verification Date
December 2022
Overall Recruitment Status
Completed
Study Start Date
November 17, 2018 (Actual)
Primary Completion Date
November 17, 2019 (Actual)
Study Completion Date
November 17, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Marina F Fahmy, MD
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dental Caries
Keywords
Bioactive Restorative Material , ART
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
110 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Group I
Arm Type
Active Comparator
Arm Description
Group I : will consist of 30 teeth that will be restored by high-viscosity glass ionomer (Fuji IX Extra) with ART approach
Arm Title
Group II
Arm Type
Active Comparator
Arm Description
Group II : will consist of 30 teeth that will be restored by bioactive restorative material (ACTIVA KIDS bioactive restorative material) with ART approach.
Intervention Type
Drug
Intervention Name(s)
Fuji IX EXTRA
Other Intervention Name(s)
Extra fast GIC
Intervention Description
High-viscosity glass ionomer (Fuji IX EXTRA)
Intervention Type
Drug
Intervention Name(s)
ACTIVA KIDS bioactive restorative material
Other Intervention Name(s)
ACTIVA , Modified composite
Intervention Description
Modified composite (ACTIVA KIDS)
Primary Outcome Measure Information:
Title
the Success Rate of ACTIVA BIOACTIVE and Fuji IX Extra GIC With ART in Class I Carious Cavity of Primary Teeth
Description
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
4 Years
Maximum Age & Unit of Time
8 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Children aged from 4 to 8 years old, in good general health
Children classified as class 3 or 4 based on Frankel et al. classification. (26)
The children have at least one primary molar with class I carious lesion.
Asymptomatic teeth (without spontaneous pain)
Exclusion Criteria:
Medically compromised patient
Presence of pulp exposure, pain, mobility
Presence of swelling, abscess or fistula near the tooth
Not accessible carious lesion to hand instruments
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Amr Mahmoud Abd EL Aziz
Organizational Affiliation
Professor of Pediatric Dentistry and Dental Public Health Department -ASU
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Reham Khaled Abou El Fadl
Organizational Affiliation
Lecturer of Pediatric Dentistry and Dental Public Health Department -ASU
Official's Role
Study Director
Facility Information:
Facility Name
Marina Fakhry Fahmy Saad
City
Cairo
Country
Egypt
12. IPD Sharing Statement
Learn more about this trial
Fluoride Release,Compressive Strength and Clinical Performance of a Bioactive Restorative Material in ART
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