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

Dental Caries Clinical Trial

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 )

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03788616
• Other study ID #: PED18-5M
• Status: Completed
• Phase: Phase 3
• Start date: November 17, 2018
• Est. completion date: November 17, 2019

Study information

• Verified date: December 2022
• Source: Ain Shams University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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) .

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 110
• Est. completion date: November 17, 2019
• Est. primary completion date: November 17, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 4 Years to 8 Years

Eligibility

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

Related Conditions & MeSH terms

• Dental Caries

Intervention

Drug:
• Fuji IX EXTRA
High-viscosity glass ionomer (Fuji IX EXTRA)
• ACTIVA KIDS bioactive restorative material
Modified composite (ACTIVA KIDS)

Locations

Country	Name	City	State
Egypt	Marina Fakhry Fahmy Saad	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Marina F Fahmy, MD

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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.	12 Month