Clinical Trials Logo

Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT04365283
Other study ID # 25091992
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date November 1, 2020
Est. completion date May 1, 2022

Study information

Verified date September 2020
Source Cairo University
Contact Rana Kamal, BDS
Phone 01226000747
Email rana.ayman747@gmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

ACTIVA BioACTIVE products are allegedly the first dental resins with a bioactive ionic resin matrix, shock-absorbing rubberized resin component, and reactive ionomer glass fillers that mimic the physical and chemical properties of natural teeth. These bioactive materials actively participate in the cycles of ionic exchange that regulate the natural chemistry of our teeth and saliva and contribute to the maintenance of tooth structure and oral health. They are claimed to have the strength, esthetics and physical properties of composites and are more bioactive than glass ionomers, combining the best attributes of both materials without compromising either one.


Description:

High caries risk patients are those who have high DMF index, high sugar intake, poor oral hygiene, inadequate salivary flow, low pH level, as well as deficient fluoride exposure.

Therefore, their management has to be adequate and proper. To overcome these setbacks, glass ionomer cements that have advantages such as similar coefficient of thermal expansion to natural tooth tissue, physicochemical adhesion to tooth structure, biocompatability, fluoride release, low shrinkage and low marginal leakage as well as anticaries properties and increased remineralization interproximally ,which is especially beneficial in high risk caries patients, have been considered as an alternative restorative material to composite and amalgam. To enhance the mechanical properties of GIs, their constituents have been modified Comparatively, resin-modified glass ionomer (RMGIs) with a longer working time, faster setting, higher early strength, and improved appearance and translucency. Unfortunately, the RMGI's mechanical properties of are different to resin composites. Progressive development of material sciences has resulted in the introduction of bioactive restorative materials. These materials can activate a tissue repair mechanism for or synthesis and elicit a response from teeth and surrounding environment. ACTIVA BioACTIVE products are allegedly the first dental resins with a bioactive ionic resin matrix, shock-absorbing rubberized resin component, and reactive ionomer glass fillers that mimic the physical and chemical properties of natural teeth. These bioactive materials actively participate in the cycles of ionic exchange that regulate the natural chemistry of our teeth and saliva and contribute to the maintenance of tooth structure and oral health. They are claimed to have the strength, esthetics and physical properties of composites and are more bioactive than glass ionomers, combining the best attributes of both materials without compromising either one.

Activa Presto light-cured material from Pulpdent is the company's latest product that features biomimicry as Activa Bioactive dual-cured material. The material diffuses fluoride, calcium, and phosphate ions that fortify the saliva and help replace essential minerals that are lost in the decay process. This highly esthetic, light-cured resin contains these ions in a stackable resin matrix that holds its shape and does not slump. This durable product is resistant to fracturing and wear, especially so on the thin areas of enamel bevels, and is indicated for all restorative procedures replacing dentin and/or enamel, anterior or posterior.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 22
Est. completion date May 1, 2022
Est. primary completion date September 1, 2021
Accepts healthy volunteers No
Gender All
Age group 20 Years to 40 Years
Eligibility Inclusion Criteria:

Proximal lesions in posterior premolars and molars and Age 20-40 years

Exclusion Criteria:

Low caries risk patients. Lack of compliance Class V in molars Systemic diseases or severe medical complications. Pregnancy. Rampant caries Disabilities

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
New Bioactive Restorative Material (ACTIVA Presto)
New Bioactive Restorative Material
Other:
High Viscosity Glass Hybrid Reinforced Glass Ionomer (EQUIA Forte)
High Viscosity Glass Hybrid Reinforced Glass Ionomer

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Rana Ayman Kamal

Outcome

Type Measure Description Time frame Safety issue
Primary Proximal Contact (modified USPHS criteria) Ordinal(Alfa/Bravo/Charlie) 6 months
Primary Proximal Contact (modified USPHS criteria) Ordinal(Alfa/Bravo/Charlie) 1 Year
Secondary Retention(modified USPHS criteria) Ordinal(Alpha/Charlie) 6 Months
Secondary Retention(modified USPHS criteria) Ordinal(Alpha/Charlie) 1 Year
See also
  Status Clinical Trial Phase
Recruiting NCT03812653 - Sleep for Stroke Management and Recovery Trial N/A
Terminated NCT05415293 - Commerical DHA Supplementation N/A
Terminated NCT03026049 - Stent Versus Conservative Treatment in Patients With Deep Venous Obstruction N/A
Completed NCT05402007 - Effects of Cardiopulmonary Rehabilitation in Participants With Post-COVID 19 Syndrome. N/A
Completed NCT03751475 - Optimizing Acute Malnutrition Management in Children Aged 6 to 59 Months in Democratic Republic of Congo N/A
Terminated NCT00589953 - High-Dose Erythropoietin in Extremely Premature Infants to Prevent/Attenuate Brain Injury: A Phase II Study Phase 2
Completed NCT01269567 - Drainage After Rectal Excision for Rectal Cancer Phase 3
Completed NCT05843591 - Exercise Interventions on Problematic Mobile Phone Use: a Multi-arm Randomized Controlled Trial
Completed NCT05529368 - Effect of Conventional Exercise and Tai Chi Exercise on College Students N/A
Completed NCT04753138 - Outcome of SBO With Calcium Silicate Sealer vs WVC With Resin Based Sealer N/A
Recruiting NCT06267989 - The Effectiveness of Early Intervention to Correct the Position of PDC:s N/A
Recruiting NCT03640091 - Pre-extractive Inter-radicular Implant Bed Preparation Versus Conventional Post-extractive Inter-radicular Implant Bed Preparation in Mandibular Molars N/A