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

NCT ID: NCT03788616

Last Updated: 2023-01-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 110 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-11-17
• Study Completion Date: 2019-11-17

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

Conditions

Dental Caries

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Group I

Group I : will consist of 30 teeth that will be restored by high-viscosity glass ionomer (Fuji IX Extra) with ART approach

Group Type: ACTIVE_COMPARATOR

Fuji IX EXTRA

Intervention Type: DRUG

High-viscosity glass ionomer (Fuji IX EXTRA)

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.

Group Type: ACTIVE_COMPARATOR

ACTIVA KIDS bioactive restorative material

Intervention Type: DRUG

Modified composite (ACTIVA KIDS)

Interventions

Fuji IX EXTRA

High-viscosity glass ionomer (Fuji IX EXTRA)

Intervention Type: DRUG

ACTIVA KIDS bioactive restorative material

Modified composite (ACTIVA KIDS)

Intervention Type: DRUG

Other Intervention Names

Extra fast GIC; ACTIVA , Modified composite

Eligibility Criteria

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

• Minimum Eligible Age: 4 Years
• Maximum Eligible Age: 8 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Marina F Fahmy, MD

OTHER

Sponsor Role: lead

Responsible Party

Marina F Fahmy, MD

Assistant lecturer of pediatric dentistry, pediatric dentistry and public health department, Ain Shams University

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Amr Mahmoud Abd EL Aziz

Role: STUDY_CHAIR

Professor of Pediatric Dentistry and Dental Public Health Department -ASU

Reham Khaled Abou El Fadl

Role: STUDY_DIRECTOR

Lecturer of Pediatric Dentistry and Dental Public Health Department -ASU

Locations

Marina Fakhry Fahmy Saad

Cairo, , Egypt

Countries

Egypt

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

PED18-5M

Identifier Type: -

Identifier Source: org_study_id