Clinical Trials Directory

Trials / Completed

CompletedNCT05466461

Clinical Assessment of Giomer Based Technology Versus Smart Bioactive Restoration in Carious Class V Cavities

Clinical Assessment of Injectable Flowable Composite With Giomer Based Technology Versus Smart Bioactive Restoration in Carious Class V Cavities (A Randomized Clinical Trial)

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
34 (actual)
Sponsor
Cairo University · Academic / Other
Sex
All
Age
18 Years – 55 Years
Healthy volunteers
Accepted

Summary

This study will compare between S-PRG-containing injectable flowable resin composite (Beautifil Flow Plus X) and smart bioactive flowable resin composite (Activa bioactive restorative) through evaluation of the modified USPHS clinical performance in patients with carious class V moderately deep cavities.

Detailed description

Bioactive glass has an amorphous structure, whereas glass-ceramics are crystallized glasses and composites of a crystalline phase in a residual glassy phase. Bioactive glass consists solely of the elements found in the body material, mainly being silicon (Si), calcium (Ca), sodium (Na), phosphorous (P), and oxygen (O) . Among the diverse kinds of bioactive glass filler, surface pre- reacted glass ionomer (S-PRG) filler has already been used for a relatively long time in some specific commercial RBCs. Most studies investigating this material assortment have focused on ion-release degree and potentially associated antibacterial effects. The restoration's surface integrity may be a key factor determining the eventual clinical beneficial effect of the alleged antibacterial properties. The antibacterial efficacy of bioactive glass depends on the concentration of the ions released from the glass. As inorganic bioactive fillers, S-PRGs have the additional ability to release ions. S-PRG filler is considered a multifunctional bioactive glass because it can release several types of ions including Al, B, F, Na, Si, and Sr. The released ions can exhibit a variety of bioactive behaviors, such as preventing fungal and bacterial adhesion, antibacterial activity, neutralizing acids, inhibiting demineralization, and enhancing remineralization. The biological effects of S-PRG fillers have been studied for several types of oral pathogens. It was reported that the elute of the S-PRG filler has a protective effect against Streptococcus mutans. Moreover, the elute of S-PRG filler reduced the density and thickness of the formed biofilm.

Conditions

Interventions

TypeNameDescription
PROCEDUREBeautifil Flow Plus X.Class V cavities will be prepared, Selective etching technique will be used with phosphoric acid etching gel for 15 seconds on enamel.Single Bond TM Universal will be applied to cavity walls and margins with agitation for 20 seconds.The adhesive will be light-cured for 20 seconds. Then Beautifil Flow Plus X composite will be placed
PROCEDUREActiva bioactive restorativeClass V cavities will be prepared, Selective etching technique will be used with phosphoric acid etching gel for 15 seconds on enamel. Bonding agent will be applied on the entire cavity and light-cured for 20 seconds then Activa bioactive restorative composite will be applied and cured for 20 seconds.

Timeline

Start date
2023-06-01
Primary completion
2025-01-01
Completion
2025-01-01
First posted
2022-07-20
Last updated
2025-05-21

Locations

1 site across 1 country: Egypt

Source: ClinicalTrials.gov record NCT05466461. Inclusion in this directory is not an endorsement.