Fluoride Release,Compressive Strength and Clinical Performance of a Bioactive Restorative Material in ART

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 )

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) .

Study Overview

• Status: Completed
• Conditions: Dental Caries
• Intervention / Treatment: Drug: Fuji IX EXTRA; Drug: ACTIVA KIDS bioactive restorative material

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

• Study Type: Interventional
• Enrollment (Actual): 110
• Phase: Phase 3

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt
    • Marina Fakhry Fahmy Saad

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 4 years to 8 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Group I; Group I : will consist of 30 teeth that will be restored by high-viscosity glass ionomer (Fuji IX Extra) with ART approach	Drug: Fuji IX EXTRA; High-viscosity glass ionomer (Fuji IX EXTRA); Other Names: Extra fast GIC
Active Comparator: Group II; Group II : will consist of 30 teeth that will be restored by bioactive restorative material (ACTIVA KIDS bioactive restorative material) with ART approach.	Drug: ACTIVA KIDS bioactive restorative material; Modified composite (ACTIVA KIDS); Other Names: ACTIVA , Modified composite

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Marina F Fahmy, MD
• Investigators: Study Chair: Amr Mahmoud Abd EL Aziz, Professor of Pediatric Dentistry and Dental Public Health Department -ASU; Study Director: Reham Khaled Abou El Fadl, Lecturer of Pediatric Dentistry and Dental Public Health Department -ASU

Study record dates

Study Major Dates

• Study Start (Actual): November 17, 2018
• Primary Completion (Actual): November 17, 2019
• Study Completion (Actual): November 17, 2019

Study Registration Dates

• First Submitted: December 14, 2018
• First Submitted That Met QC Criteria: December 26, 2018
• First Posted (Actual): December 27, 2018

Study Record Updates

• Last Update Posted (Estimate): January 19, 2023
• Last Update Submitted That Met QC Criteria: December 22, 2022
• Last Verified: December 1, 2022

More Information

Terms related to this study

• Keywords: Bioactive Restorative Material , ART
• Additional Relevant MeSH Terms: Stomatognathic Diseases; Tooth Demineralization; Tooth Diseases; Dental Caries
• Other Study ID Numbers: PED18-5M

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No