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)

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Dental Caries
• Intervention / Treatment: Procedure: Beautifil Flow Plus X.; Procedure: Activa bioactive restorative

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.

• Study Type: Interventional
• Enrollment (Anticipated): 34
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Bassma Reda AbdelHafeez, Assistant Lecturer; Phone Number: 00201092182646; Email: Basma.reda@dentistry.cu.edu.eg
• Study Contact Backup: Name: Mai Mamdouh, Associate Professor; Email: Mai.Mamdouh@dentistry.cu.edu.eg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: 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.	Procedure: 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
ACTIVE_COMPARATOR: 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	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Assessment of Modified USPHS Criteria (Marginal discoloration) change over time	Alfa: there is no visual evidence of marginal discoloration different from the color of the restorative material and from the color of the adjacent tooth structure. Bravo: there is visual evidence of marginal discoloration at the junction of the tooth structure and the restoration that has not penetrated along the restoration in a pulpal direction. Charlie: there is visual evidence of marginal discoloration at the junction of the tooth structure and the restoration, but the discoloration has penetrated along the restoration in a pulpal direction.	Change between baseline,6 months and 12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Assessment of Modified USPHS criteria. (Secondary caries) change over time	Alfa: no caries is present. Charlie: caries is present.	Change between baseline,6 months and 12 months

Collaborators and Investigators

• Sponsor: Cairo University

Publications and helpful links

General Publications

• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): November 1, 2022
• Primary Completion (ANTICIPATED): November 1, 2023
• Study Completion (ANTICIPATED): January 1, 2024

Study Registration Dates

• First Submitted: July 15, 2022
• First Submitted That Met QC Criteria: July 18, 2022
• First Posted (ACTUAL): July 20, 2022

Study Record Updates

• Last Update Posted (ACTUAL): September 22, 2022
• Last Update Submitted That Met QC Criteria: September 20, 2022
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Stomatognathic Diseases; Tooth Demineralization; Tooth Diseases; Dental Caries
• Other Study ID Numbers: 236756

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No