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

NCT03788616 | Completed Phase 3 Results DMC FDA Drug

• 1 other identifier: PED18-5M
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 1

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) .

Conditions

Dental Caries

Keywords

Bioactive Restorative Material , ART

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Group I

ACTIVE COMPARATOR

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

Group II

ACTIVE COMPARATOR

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

Interventions

Fuji IX EXTRA DRUG

High-viscosity glass ionomer (Fuji IX EXTRA)

Also known as: Extra fast GIC

Group I

ACTIVA KIDS bioactive restorative material DRUG

Modified composite (ACTIVA KIDS)

Also known as: ACTIVA , Modified composite

Group II

Eligibility Criteria

• Age: 4 Years - 8 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Marina F Fahmy, MD: lead

Study Sites (1)

Marina Fakhry Fahmy Saad

Cairo, Egypt

Location

MeSH Terms

Conditions

Dental Caries

Condition Hierarchy (Ancestors)

Tooth Demineralization; Tooth Diseases; Stomatognathic Diseases

Results Point of Contact

• Title: Dr. Marina Fakhry assistant lecturer of pediatric dentistry
• Organization: Faculty of dentistry, Ain Shams University

Dr.marina.fakhry@gmail.com

01273731722

Study Officials

• Amr Mahmoud Abd EL Aziz

  Professor of Pediatric Dentistry and Dental Public Health Department -ASU

  STUDY CHAIR

• Reham Khaled Abou El Fadl

  Lecturer of Pediatric Dentistry and Dental Public Health Department -ASU

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant lecturer of pediatric dentistry, pediatric dentistry and public health department, Ain Shams University

Study Record Dates

• First Submitted: December 14, 2018
• First Posted: December 27, 2018
• Study Start: November 17, 2018
• Primary Completion: November 17, 2019
• Study Completion: November 17, 2019
• Last Updated: January 19, 2023
• Results First Posted: January 19, 2023

Record last verified: 2022-12

Locations

EG (1)