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Completed

NCT Number: NCT03788616

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

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) .

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Key information

Conditions

Dental Caries Stomatognathic Diseases Tooth Demineralization Tooth Diseases

Age range

4 year–8 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Marina Fakhry Fahmy Saad

Cairo, Egypt

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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)

Exclusion criteria

  • 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

Treatment and study plan

Fuji IX EXTRA

Drug

High-viscosity glass ionomer (Fuji IX EXTRA)

Other names: Extra fast GIC

ACTIVA KIDS bioactive restorative material

Drug

Modified composite (ACTIVA KIDS)

Other names: ACTIVA , Modified composite

Primary outcomes

  1. the Success Rate of ACTIVA BIOACTIVE and Fuji IX Extra GIC With ART in Class I Carious Cavity of Primary Teeth

    Time frame: 12 Month

    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.

Sponsors and collaborators

Lead sponsor

Marina F Fahmy, MD

Other

Registry information

Official study 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 )

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Dec 27, 2018
Registry last updated
Jan 19, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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