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

NCT ID: NCT05466461

Last Updated: 2025-05-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 34 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-06-01
• Study Completion Date: 2025-01-01

Brief 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

Dental Caries

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Beautifil Flow Plus X.

Giomers is a hybrid material category which contains Surface Pre-Reacted Glass-ionomer filler or S-PRG filler is produced from fluoroboro-alumino-silicate glass and polyacrylic acid through an acid-base reaction to form a stable glass ionomer phase on glass filler particle surfaces. S-PRG fillers can release and recharge fluoride. Also, the S-PRG filler-containing resinous materials are able to release various ions, such as aluminum (Al3+), boron (BO3 3-), fluoride (F- ), sodium (Na+), silicon (SiO3 2-), and strontium (Sr2+), in neutral and acidic conditions.

Group Type: EXPERIMENTAL

Beautifil Flow Plus X.

Intervention Type: PROCEDURE

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

Activa bioactive restorative

Activa BioACTIVE Restorative (Activa), developed by Pulpdent (Watertown, MA, USA), is a new bioactive restorative material that combines the advantages of an RMGIC (resin modified glass ionomer cement) and RBC (resin based composite), representing a new category of restorative materials that are ion releasing. It contains methacrylate- based monomers, a modified polyacrylic acid, modified Diurethane Dimethacrylate (rubberized resin), and fillers

Group Type: ACTIVE_COMPARATOR

Activa bioactive restorative

Intervention Type: PROCEDURE

Class 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.

Interventions

Beautifil 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

Intervention Type: PROCEDURE

Activa bioactive restorative

Class 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.

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• ages 18 to 55 years.
• Male or female patients.
• Patients with no history of allergic reactions to methacrylate compounds and in good general health.
• Patients with good general health.
• Patients with good recall availability. Patients required Class V restoration
• Vital teeth with normal appearance and morphology.
• Absence of clinical symptoms of irreversible pulpitis, such as spontaneous pain or sensitivity to pressure.
• Absence of clinical diagnosis of pulp exposure, fistula, swelling of periodontal tissues, and/or abnormal tooth mobility .
• No defects and lesions for other operative intervention, occlusal and proximal contacts with adjacent teeth.

Exclusion Criteria

• Patients with history of any adverse reaction to clinical materials of the types to be used in the evaluation.

• Pregnant and lactating females.
• Any patients with medical and/or dental histories which could possibly complicate the provision of the proposed restoration and/or influence behavior and performance of the restorations in clinical service.
• They are included in the evaluation of other restorative materials and systems involving the anterior and/or posterior teeth.
• Patients who maintain an unacceptable standard of oral hygiene.
• Teeth with noncarious cervical lesions.
• Severe tooth sensitivity.
• Non-vital or fracture or cracked teeth.
• Tooth with defective restoration.
• Teeth with advanced periodontal diseases.
• There is evidence occlusal parafunctions and/or atypical tooth wear.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Cairo University

OTHER

Sponsor Role: lead

Responsible Party

Bassma Reda Abdelhafeez

Principle Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Cairo University

Cairo, , Egypt

Countries

Egypt

References

Yoshihara K, Nagaoka N, Maruo Y, Sano H, Yoshida Y, Van Meerbeek B. Bacterial adhesion not inhibited by ion-releasing bioactive glass filler. Dent Mater. 2017 Jun;33(6):723-734. doi: 10.1016/j.dental.2017.04.002. Epub 2017 Apr 29.

Reference Type: BACKGROUND

PMID: 28465066 (View on PubMed)

Nomura R, Morita Y, Matayoshi S, Nakano K. Inhibitory effect of surface pre-reacted glass-ionomer (S-PRG) eluate against adhesion and colonization by Streptococcus mutans. Sci Rep. 2018 Mar 22;8(1):5056. doi: 10.1038/s41598-018-23354-x.

Reference Type: BACKGROUND

PMID: 29568011 (View on PubMed)

Tonprasong W, Inokoshi M, Tamura M, Uo M, Wada T, Takahashi R, Hatano K, Shimizubata M, Minakuchi S. Tissue Conditioner Incorporating a Nano-Sized Surface Pre-Reacted Glass-Ionomer (S-PRG) Filler. Materials (Basel). 2021 Nov 4;14(21):6648. doi: 10.3390/ma14216648.

Reference Type: BACKGROUND

PMID: 34772173 (View on PubMed)

Other Identifiers

236756

Identifier Type: -

Identifier Source: org_study_id