Clinical trial NCT04127929: Investigation of Glass Carbomer Performance
Official title: 12-Month Clinical Performance Evaluation of a Current Glass Carbomer Restorative System
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dental Caries
Keywords: glass ionomer, composite, clinical
Lead sponsor: Okan University
Sponsor class: OTHER
Collaborators: name: Bezmialem Vakif University
First posted: 2019-10-16
Enrollment: 36
Sex: ALL
Minimum age (years): 25
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this in vivo study was to evaluate the clinical 1 year follow-up of silica and flouroapatite reinforced glass carbomer filling material.

Detailed description: The aim of this in vivo study was to evaluate the clinical 1 year follow-up of silica and flouroapatite reinforced glass carbomer filling material.

In this study, total of 100 (46 class I, 54 class II) restorations were performed in 36 patients. All cavities were prepared conventionally. Half of the restorations were restored with nano composite resin (Tokuyama Estelite, Tokuyama Dental, Japan) and the other half were restored with glass carbomer material (GCP Dental, The Netherlands). Rubber-dam was used for isolation. Before the replacement of composite restorations, enamel edges were etched according to selective etching method. Then universal adhesive system was applied. Composite resin was applied to the cavity in 2 mm layers by incramental technique. Glass carbomer was placed with bulk technique by applying finger pressure with surface covering. Composite restorations were polymerized with LED light curing unit. Glass carbomer restorations were cured its own special curing unit. Restorations were evaluated with modified USPHS criteria at the end of the first week, 6 months and 12 months. Data were analyzed using Fisher's Exact Chi-Square test, Fisher Freeman Halton Test and Continuity (Yates) Correction. Wilcoxon sign test was used for intra-group comparisons of the parameters. Statistically significance was evaluated at p \<0.05.

Eligibility criteria: Inclusion Criteria:

1. 20-25 years of age
2. No systemic diseases
3. Presence of molar / premolar teeth with occlusal and / or interface caries
4. Lack of parafunctional habits such as clenching and grinding of teeth
5. Lack of cooperation problems
6. Accepted regular visits -

Exclusion Criteria:

* 1-Any endodontic treatment or withdrawal indications (abscess, swelling and fistula complaints, palpation and percussion pain, spontaneous or night pain) 2- Teeth with congenital developmental defect 3- Teeth with pathological mobility 4- Teeth which do not have normal occlusion due to skeletal or pathological reasons 5- Lack of contact or opposite teeth

Primary outcomes:
measure: Evaluation of criterias
timeFrame: 1 week
Secondary outcomes:
measure: Evaluation of criterias
timeFrame: 6-months
Other outcomes:
measure: Evaluations of criterias
timeFrame: 12-months
Locations:
city: Istanbul
country: Turkey
facility: Bezmialem vakif university
state: Fatih
Study officials:
affiliation: Bezmialem Vakif University
name: Zeynep Buket Kaynar, Dr
role: PRINCIPAL_INVESTIGATOR
References: