Clinical trial NCT04488380: Clinical Performance of Glass Ionomer Versus Resin Composite Restorations
Official title: Clinical Performance of Glass Ionomer Versus Resin Composite Restorations Performed Without Rubber-Dam Isolation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dental Caries
Keywords: restorative glass ionomer
Lead sponsor: Tokat Gaziosmanpasa University
Sponsor class: OTHER
Collaborators: name: Izmir Katip Celebi University
First posted: 2020-07-28
Enrollment: 56
Sex: ALL
Minimum age (years): 15
Maximum age (years): 19
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: One of the Glass ionomer restorative or Resin composite restorative materials were applied to carious mandibular 2nd molar teeth.
Primary purpose: TREATMENT

Brief summary: The aim of this randomised-controlled, single-blind, split-mouth, and single-centre clinical trial was to evaluate the 2-year clinical performances of a high-viscosity glass ionomer and nanohybrid composite resin in occlusal restorations on mandibular second molar teeth in patients at risk for salivary contamination.

Detailed description: Occlusal carious lesions on the right and left mandibular second molars of 56 patients (26 females, 30 males) were restored in a split-mouth design. A high-viscosity glass ionomer (Hv-GIC) (Equia, GC) was used to restore the carious lesions in patients in the treatment group, while a nano-hybrid composite resin (GSO) (GrandioSO, Voco) was used for patients in the control group. Clinical evaluations of the restorations were performed at 1-week, 6-month, 1-year, and 2-year follow-up appointments, according to the FDI criteria. Data were analysed using the Friedman's analysis of variance and Mann-Whitney U tests (α=0.05).

Eligibility criteria: Inclusion Criteria:

* good health and oral hygiene,
* occlusal carious lesions on both mandibular second molars,
* mandibular second molars with mesial and occlusal contacts,
* contraindication to the use of rubber dam,
* the ability to return for periodic follow-up visits.

Exclusion Criteria:

* restoration on mandibular second molars.

Primary outcomes:
measure: Surface lustre of dental restorations
timeFrame: Changes of dental restorations regarding surface lustre were observed at 1-week, 6-month, 1-year, and 2-year results were compared between two restorative material and change of material suring the study is observed
measure: Staining restoration surface and restoration margin
timeFrame: Changes of dental restorations regarding surface lustre were observed at 1-week, 6-month, 1-year, and 2-year results were compared between two restorative material and change of material suring the study is observed
measure: Fracture of material and retention
timeFrame: Changes of dental restorations regarding Fracture of material and retention were observed at 1-week, 6-month, 1-year, and 2-year results were compared between two restorative material and change of material suring the study is observed
measure: Recurrence of caries
timeFrame: Changes of dental restorations regarding recurrence of caries were observed at 1-week, 6-month, 1-year, and 2-year results were compared between two restorative material and change of material suring the study is observed
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: Gurgan S, Kutuk ZB, Yalcin Cakir F, Ergin E. A randomized controlled 10 years follow up of a glass ionomer restorative material in class I and class II cavities. J Dent. 2020 Mar;94:103175. doi: 10.1016/j.jdent.2019.07.013. Epub 2019 Jul 25.
citation: Turkun LS, Kanik O. A Prospective Six-Year Clinical Study Evaluating Reinforced Glass Ionomer Cements with Resin Coating on Posterior Teeth: Quo Vadis? Oper Dent. 2016 Nov/Dec;41(6):587-598. doi: 10.2341/15-331-C. Epub 2016 Aug 29.
citation: Hatirli H, Yasa B, Celik EU. Clinical performance of high-viscosity glass ionomer and resin composite on minimally invasive occlusal restorations performed without rubber-dam isolation: a two-year randomised split-mouth study. Clin Oral Investig. 2021 Sep;25(9):5493-5503. doi: 10.1007/s00784-021-03857-0. Epub 2021 Mar 8.