Clinical trial NCT06211582: Clinical Performances of 3-different Tooth-colored Restorative Materials in Class-II Cavities
Official title: Clinical Performances of 3-different Tooth-colored Restorative Materials in Class-II Cavities
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Caries,Dental
Keywords: Alkasite-based
Posterior resin composite
Class II restoration
Glass Hybrid
Lead sponsor: Hacettepe University
Sponsor class: OTHER
First posted: 2024-01-18
Enrollment: 47
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The goal of this clinical trial comparatively investigate the clinical performances of 3 different tooth-colored restorative materials in the treatment of Class II cavities after 6 months and one year.

Detailed description: High plaque accumulation at the proximal surfaces of posterior teeth can lead to the development of caries and the necessity of dental treatments.The complexity of application methods for resin composites could influence the risk of secondary caries due to bacterial microleakage.In modern dentistry, simplified, esthetic, and satisfactory restoration of tooth decay has led to innovative material developments.Rapidly cured restorative materials applied in large increments with self-adhesive properties became an important solution for easy and effective applications.

Restorative materials with bioactive or caries-protective abilities have been introduced, such as glass hybrid materials. Recently, to overcome the limitations of restorative materials, it was attempted to add caries-protective ions, especially alkaline and alkaline earth ions, such as calcium, in addition to phosphate or fluoride. This newly introduced material contains alkalizing properties due to the release of hydroxyl ions.

In 2016, Ivoclar Vivadent developed a new restorative material consisting of a powder and a liquid part and commercially named this product "Cention N".

Cention N has bioactive properties like glass ionomer cements. It has been developed to prevent demineralisation by neutralising acids through ion release. It contains alkaline fillers. Therefore, a new classification as "Alkasites" has emerged.

One lesion in each patient will be randomly assigned to be restored using either the GC Gradia Direct Posterior, Cention N and Equia Forte HT. The adhesive, GC Solare Universal Bond will be used for adhesive procedures. The clinical procedure for the restorations will be performed by a single operator. The restorations will be evaluated by two calibrated examiners at baseline and at 6, 12, months in accordance with the FDI criteria. Data will be statistically analyzed using the Chi-square and Fischer's exact tests (p \< 0.05).

Eligibility criteria: Inclusion Criteria:

* Healthy individuals who do not have any systemic disease that prevents restorative treatment
* Individuals between the ages of 18-65
* Brushing your teeth twice a day
* Having at least 20 teeth in occlusion and at least 3 approximal lesions with antagonist teeth in the opposite arch
* Volunteer individuals who agree to participate in the research and sign the informed consent form and who have undergone initial periodontal treatment will be included in the study.

Exclusion Criteria:

* Pregnant or breastfeeding women
* Individuals with advanced periodontal disease
* Individuals using removable partial dentures
* Individuals with bruxism
* Individuals with malocclusion
* Patients with known allergies to resin-based restorative materials and bonding agents
* Patients with a history of allergy to local anesthesia
* Endodontic treatment, teeth that need pulp capping or endodontic treatment is available

Primary outcomes:
measure: Surface gloss/lustre and roughness
timeFrame: From Baseline to 12 Month
measure: Surface and marginal staining
timeFrame: From Baseline to 12 Month
measure: Colour match/stability and translucency
timeFrame: From Baseline to 12 Month
measure: Anatomic form
timeFrame: From Baseline to 12 Month
measure: Fracture of restorative material and retention
timeFrame: From Baseline to 12 Month
measure: Marginal adaptation
timeFrame: From Baseline to 12 Month
measure: Proximal contact point and food impaction
timeFrame: From Baseline to 12 Month
measure: Radiographic examination
timeFrame: From Baseline to 12 Month
measure: Postoperative sensitivity and tooth vitality
timeFrame: From Baseline to 12 Month
measure: Recurrence of initial pathology (secondary caries)
timeFrame: From Baseline to 12 Month
measure: Tooth cracks and fractures
timeFrame: From Baseline to 12 Month
measure: Localised reactions of soft tissue
timeFrame: From Baseline to 12 Month
measure: Oral and somatic/ psychiatric symptoms
timeFrame: From Baseline to 12 Month
Secondary outcomes:
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Hacettepe University
Study officials:
affiliation: Hacettepe University
name: Filiz Yalçın Çakır, Prof.
role: PRINCIPAL_INVESTIGATOR
affiliation: Hacettepe University
name: Uzay Koç Vural, Assoc. Prof.
role: PRINCIPAL_INVESTIGATOR
affiliation: Hacettepe University
name: Kemal Işıklı
role: PRINCIPAL_INVESTIGATOR
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: Bektas Donmez S, Uysal S, Dolgun A, Turgut MD. Clinical performance of aesthetic restorative materials in primary teeth according to the FDI criteria. Eur J Paediatr Dent. 2016 Sep;17(3):202-212.