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

NCT05466461 | Completed DMC

• 1 other identifier: 236756
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

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.

Conditions

Dental Caries

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Assessment of Modified USPHS criteria. (Secondary caries) change over time

  Change between baseline,6 months and 12 months

Study Arms (2)

Beautifil Flow Plus X.

EXPERIMENTAL

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.

Activa bioactive restorative

ACTIVE COMPARATOR

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

Interventions

Beautifil Flow Plus X. 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

Beautifil Flow Plus X.

Activa bioactive restorative 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.

Activa bioactive restorative

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Cairo University

Cairo, 11553, Egypt

Location

Related Publications (3)

• 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.

  PMID: 28465066 BACKGROUND

• 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.

  PMID: 29568011 BACKGROUND

• 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.

  PMID: 34772173 BACKGROUND

MeSH Terms

Conditions

Dental Caries

Interventions

ACTIVA BioACTIVE-RESTORATIVE

Condition Hierarchy (Ancestors)

Tooth Demineralization; Tooth Diseases; Stomatognathic Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: During treatment, the type of material will be concealed from the patient, and the patient will have no information which material will be used. The type of restoration will not mentioned in the patient's file. Instead, it will be replaced by a combination which the evaluators will be not familiar with. The operator will be blinded for the type of restoration during tooth preparation and was informed only at the time of restoration placement. The purpose of this discretion is to ensure double blinding both at the patient, as well as the evaluators level.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle Investigator

Model Details: Compare between S-PRG-containing injectable flowable resin composite (Beautifil Flow Plus X) and smart bioactive flowable resin composite (Activa bioactive restorative) over one year through evaluation of the modified USPHS clinical performance in patients with carious class V moderately deep cavities.

Study Record Dates

• First Submitted: July 15, 2022
• First Posted: July 20, 2022
• Study Start: June 1, 2023
• Primary Completion: January 1, 2025
• Study Completion: January 1, 2025
• Last Updated: May 21, 2025

Record last verified: 2025-05

Locations

EG (1)