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

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ClinicalTrials.gov Identifier: NCT03788616
Recruitment Status : Recruiting
First Posted : December 27, 2018
Last Update Posted : July 9, 2019
Sponsor:
Information provided by (Responsible Party):
Marina F Fahmy, MD, Ain Shams University

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
Dental Caries 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


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 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 : November 17, 2018
Estimated Primary Completion Date : July 2019
Estimated Study Completion Date : July 2019

Resource links provided by the National Library of Medicine


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 Name: 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 Name: ACTIVA , Modified composite




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 [ Time Frame: 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




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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03788616


Contacts
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Contact: Marina fahmy saad, resident 01273731722 ext 02 dr.marina.fakhry@gmail.com
Contact: Abanoub Fayez Aziz 01202248330 ext 02 captin.abanoub106@gmail.com

Locations
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Egypt
Marina Fakhry Fahmy Saad Recruiting
Cairo, Egypt
Contact: marina fakhry fahmy saad    01273731722 ext 02    dr.marina.fakhry@gmail.com   
Sponsors and Collaborators
Marina F Fahmy, MD
Investigators
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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

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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     History of Changes
Other Study ID Numbers: PED18-5M
First Posted: December 27, 2018    Key Record Dates
Last Update Posted: July 9, 2019
Last Verified: July 2019

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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, Ain Shams University:
Bioactive Restorative Material , ART
Additional relevant MeSH terms:
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Dental Caries
Tooth Demineralization
Tooth Diseases
Stomatognathic Diseases
Fluorides
Cariostatic Agents
Protective Agents
Physiological Effects of Drugs