Clinical trial NCT05466461: Clinical Assessment of Giomer Based Technology Versus Smart Bioactive Restoration in Carious Class V Cavities
Official title: Clinical Assessment of Injectable Flowable Composite With Giomer Based Technology Versus Smart Bioactive Restoration in Carious Class V Cavities (A Randomized Clinical Trial)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dental Caries
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2022-07-20
Enrollment: 34
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Assessment of Modified USPHS Criteria (Marginal discoloration) change over time
timeFrame: Change between baseline,6 months and 12 months
Secondary outcomes:
measure: Assessment of Modified USPHS criteria. (Secondary caries) change over time
timeFrame: Change between baseline,6 months and 12 months
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Cairo University
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.