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

Sponsor
Marina F Fahmy, MD (Other)
Overall Status
Completed
CT.gov ID
NCT03788616
Collaborator
(none)
70
Enrollment
1
Location
2
Arms
12
Actual Duration (Months)
5.8
Patients Per Site Per Month

Study Details

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) .

Condition or Disease Intervention/Treatment Phase
  • Drug: Fuji IX EXTRA
  • Drug: ACTIVA KIDS bioactive restorative material
 Phase 2/Phase 3

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 Design

Study Type:
Interventional
Actual Enrollment :
70 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
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 )
Actual Study Start Date :
Nov 17, 2018
Actual Primary Completion Date :
Nov 17, 2019
Actual Study Completion Date :
Nov 17, 2019

Arms and Interventions

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. the longevity of ACTIVA BIOACTIVE restorative material versus high -viscosity glass ionomer in (ART) in Class I carious cavity of primary teeth [9 Month]

      according to the Frencken and Holmgren criteria in the class I restoration. 0 Present, good 1 Present, slight marginal defect for whatever reason, at any one place which is less than 0.5 mm in depth. No repair is needed. 2 Present, marginal defect for whatever reason, at any one place which is deeper than 0.5 mm but less than 1.0 mm. Repair is needed. 3 Present, gross defect of more than 1.0 mm in depth. Repair is needed. 4 Not present, restoration has (almost) completely disappeared. Treatment is needed. 5 Not present, other restorative treatment has been performed. 6 Not present, tooth has been extracted. 7 Present wear and tear gradually over larger parts of the restoration but is less than 0.5 mm at the deepest point. No repair is needed. 8 Present, wear and tear gradually over larger parts of the restoration which is deeper than 0.5 mm Repair is needed. 9 Unable to diagnosis

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    4 Years to 8 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Marina Fakhry Fahmy Saad Cairo Egypt

    Sponsors and Collaborators

    • 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 Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Marina F Fahmy, MD, Resident and candidate in master degree at pediatric dentistry and public health department, Ain Shams University, Ain Shams University
    ClinicalTrials.gov Identifier:
    NCT03788616
    Other Study ID Numbers:
    • PED18-5M
    First Posted:
    Dec 27, 2018
    Last Update Posted:
    Jan 10, 2020
    Last Verified:
    Jul 1, 2019
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Marina F Fahmy, MD, Resident and candidate in master degree at pediatric dentistry and public health department, Ain Shams University, Ain Shams University
    Bioactive Restorative Material , ART
    Additional relevant MeSH terms:
    Dental Caries

    Study Results

    No Results Posted as of Jan 10, 2020