Clinical Performances of 3-different Tooth-colored Restorative Materials in Class-II Cavities

NCT06211582 | Completed

• 1 other identifier: KA-22015
• Study Type: interventional
• Target: 47
• Locations: 1 country
• Sites: 1

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.

Conditions

Caries,Dental

Keywords

Alkasite-based; Posterior resin composite; Class II restoration; Glass Hybrid

Outcome Measures

Primary Outcomes (13)

• Surface gloss/lustre and roughness

  Observers evaluated the restorations was performed using FDI criteria regarding surface gloss/lustre and roughness. Surface gloss/lustre and roughness was evaluated by 2 independent clinicians. Visual inspection with a mirror was performed.Scores; 1: Comparable to enamel 2: Slightly dull, not noticeable from speaking distance 3: Dull surface but acceptable if covered with film of saliva 4: Rough surface, cannot be masked by saliva film, simple polishing is not sufficient 5: Quite rough, unacceptable plaque retentive surface

  From Baseline to 12 Month

• Surface and marginal staining

  Observers evaluated the restorations was performed using FDI criteria regarding surface and marginal staining. Surface and marginal staining was evaluated by 2 independent clinicians. Visual inspection with a mirror was performed. Scores; 1: No marginal or surface staining 2: . Minor staining, easily removable 3: Moderate staining not noticeable from a speaking distance, also present on other teeth. Not aesthetically unacceptable 4: Surface staining recognizable from speaking distance. Or severe localized marginal staining not removable by polishing 5: Severe surface staining or unacceptable. Generalized and profound marginal discoloration.

  From Baseline to 12 Month

• Colour match/stability and translucency

  Observers evaluated the restorations was performed using FDI criteria regarding colour match/stability and translucency. Colour match/stability and translucency was evaluated by 2 independent clinicians. Visual inspection with a mirror was performed. Scores; 1: Colour and translucency of the restoration have a clinically excellent match with the surrounding enamel 2: Minor deviations in shade between tooth and restoration are apparent 3: Clear deviation but acceptable. Does not affect aesthetics 4: Colour and/ or translucency are clinically unsatisfactory, recognisable from speaking distance 5: Colour match and/or translucency are clinically unsatisfactory

  From Baseline to 12 Month

• Anatomic form

  Observers evaluated the restorations was performed using FDI criteria regarding anatomic form. Anatomic form was evaluated by 2 independent clinicians. Visual inspection with a mirror was performed. Scores; 1: Form is ideal 2: Form deviates slightly from the remainder of the tooth 3: Form differs but is not aesthetically displeasing 4: Anatomic form is altered, the aesthetic result is unacceptable 5: Anatomic form is unsatisfactory and/or lost

  From Baseline to 12 Month

• Fracture of restorative material and retention

  Observers evaluated the restorations was performed using FDI criteria regarding fracture of restorative material and retention. Fracture of restorative material and retention was evaluated by 2 independent clinicians. Visual inspection with a mirror was performed. Scores; 1: Restoration retained, no fractures, cracks or chipping 2: Small hairline crack 3: Two or more or larger hairline cracks and/or chipping (not affecting the marginal integrity or proximal contact) 4: Chipping fractures affect marginal quality and/or proximal contacts; bulk fractures with or without partial loss of (\<1/2 of the restoration) 5: (Partial or complete) loss of the restoration

  From Baseline to 12 Month

• Marginal adaptation

  Observers evaluated the restorations was performed using FDI criteria regarding marginal adaptation. Marginal adaptation was evaluated by 2 independent clinicians. Visual inspection with a mirror was performed. Scores; 1: Harmonious outline, no gaps, no discoloration 2: Small marginal chip fracture can be eliminated by polishing 3: Vertical/horizontal gap \<250 μm, easily perceptible with a blunt explorer with a tip diameter of 250 μm. Several small marginal fractures cannot be modified without damage and are unlikely to cause longterm effects 4: Vertical/horizontal gap \> 250 μm, may result in exposure of dentine or base 5: Restoration is loose but in situ

  From Baseline to 12 Month

• Proximal contact point and food impaction

  Observers evaluated the restorations was performed using FDI criteria regarding proximal contact point and food impaction. Proximal contact point and food impaction was evaluated by 2 independent clinicians. Visual inspection with a dental floss and metal blades was performed. Scores; 1: Normal contact point (dental floss can be inserted but not 50 μm blade) 2: Slightly too strong but acceptable. Floss can only be passed with force 3: Slightly too weak (50 μm metal blade can pass easily whereas 100 μm \[two blades\] cannot) 4: 100 μm (two 50 μm metal blades) can easily pass and possible damage (food impaction) 5: Too weak and/ or clear damage (food impaction) and/or pain gingivitis

  From Baseline to 12 Month

• Radiographic examination

  Observers evaluated the restorations was performed using FDI criteria regarding radiographic examination. Radiographic examination was evaluated by 2 independent clinicians.Scores; 1: No pathology, harmonious transition between restoration and tooth 2: Small visible but acceptable excess and/or a positive/ negative step or gap \<150 μm 3: Gaps and/or positive/negative step \<250 μm 4: Gaps and/or positive/negative step \>250 μm and/or marked interradicular excess material 5: Gaps \>500 μm and/ or secondary caries or apical pathology, tooth/ restoration fracture

  From Baseline to 12 Month

• Postoperative sensitivity and tooth vitality

  Observers evaluated the restorations was performed using FDI criteria regarding postoperative sensitivity and tooth vitality. Postoperative sensitivity and tooth vitality was evaluated by 2 independent clinicians. Scores; 1: No hypersensitivity, normal vitality 2: Low hypersensitivity for a limited period of time, normal vitality 3: Premature/slightly more intense or delayed/weak hypersensitivity. No subjective complaints 4:Premature/very intense or extremely delayed/weak hypersensitivity with subjective complaints. Or negative sensitivity 5: Very intense, acute pulpitis or non vital tooth. Removal of restoration with or without immediate root canal treatment is required or the tooth must be extracted

  From Baseline to 12 Month

• Recurrence of initial pathology (secondary caries)

  Observers evaluated the restorations was performed using FDI criteria regarding recurrence of initial pathology (secondary caries). Recurrence of initial pathology (secondary caries) was evaluated by 2 independent clinicians. Visual inspection with a mirror was performed. Scores; 1: No secondary or primary caries 2: Very small, localized demineralization area 3: Larger areas of demineralisation, preventive measures necessary (dentine not exposed) 4: Caries with cavitation 5: Deep secondary caries or exposed dentine that is not accessible for repair

  From Baseline to 12 Month

• Tooth cracks and fractures

  Observers evaluated the restorations was performed using FDI criteria regarding tooth cracks and fractures. Tooth cracks and fractures was evaluated by 2 independent clinicians. Visual inspection with a mirror was performed. Scores; 1: Complete integrity 2: Minor marginal crack or a hairline crack which cannot be probed. The patient has no clinical symptoms 3: Enamel split or crack \<250 μm. No adverse effects 4: Major enamel split (gap \>250 μm or dentine/base exposed. Or crack\>250 μm (explorer penetrates) 5: Cusp or tooth fracture

  From Baseline to 12 Month

• Localised reactions of soft tissue

  Observers evaluated the restorations was performed using FDI criteria regarding localised reactions of soft tissue. Localised reactions of soft tissue in direct contact with the restoration was evaluated by 2 independent clinicians. Scores; 1: Healthy mucosa adjacent to restoration 2: Healthy after minor removal of mechanical irritations (sharp edges etc.) 3: Alteration of mucosa but no suspicion of causal relationship with filling material 4: Suspected mild allergic, lichenoid or toxicological reaction 5: Suspected severe allergic, lichenoid or toxicological reaction

  From Baseline to 12 Month

• Oral and somatic/ psychiatric symptoms

  Observers evaluated the restorations was performed using FDI criteria regarding oral and somatic/ psychiatric symptoms. Oral and somatic/ psychiatric symptoms in direct contact with the restoration was evaluated by 2 independent clinicians. Scores; 1: No symptoms of adverse effects 2: Short-term minor transient symptoms 3: Minor oral and/or general symptoms of malaise 4: Persistent oral/general symptoms, recurrent symptoms 5: Acute/severe oral/general symptoms requires immediate replacement

  From Baseline to 12 Month

Study Arms (3)

Cention N (Ivoclar Vivadent, Schaan, Liechtenstein)

EXPERIMENTAL

Powder: Calcium-fluoro-silicate glass, barium glass, calcium-barium-aluminium fluoro-silicate glass, iso-fillers, ytterbium trifluoride, initiators and pigments. Liquid: Dimethacrylates, initiators, stabilizers, additives and mint flavour. The mixing ratio was 2 parts powder and 2 drops of liquid or 3 parts powder and 3 drops.After distributing the powder and liquid side by side on a mixing pad, the liquid was spread to expand the surface.The first part of the powder was mixed with the entire liquid dispensed on the mixing pad.After the components have been thoroughly mixed, add the remaining powder and stirred again until a homogeneous consistency is obtained (45 - 60 seconds). After careful adaptation to the cavity and densification, occlusal excesses were removed.

Device: Cention N (Ivoclar Vivadent, Schaan, Liechtenstein)

Equia Forte HT ( GC, Tokyo, Japan)

EXPERIMENTAL

Powder: 95% strontium fluoroalumino-silicate glass. Liquid: 5% polyacrilic acid. Equia Forte HT was mixed in a capsule (10 seconds) and injected into the cavity. After a 2.5 min curing time, occlusal excesses were removed. Equia Coat (GC, Tokyo, Japan) was then applied and light-cured (D-Light Pro, GC, Tokyo, Japan 1,400 mW/cm2) for 20 seconds.

Device: Equia Forte HT ( GC, Tokyo, Japan)

Gradia Direct Posterior ( GC, Tokyo, Japan)

EXPERIMENTAL

Matrix: Urethanedimethacrylate (UDMA), dymethacrylate camphorquinone. Filler: fluoro-alumino-silicate glass silica powder. After completing the cavity, the enamel surface was selectively roughened using 37% orthophosphoric acid for 30 seconds. Subsequently, GC Solare Universal Bond adhesive agent (GC Corp., Tokyo, Japan) was utilized. It was applied in 2mm layers in accordance with the composite manufacturer's instructions. Each layer was polymerized for 20 seconds.

Device: Gradia Direct Posterior ( GC, Tokyo, Japan)

Interventions

Cention N (Ivoclar Vivadent, Schaan, Liechtenstein) DEVICE

The Alkasite-Based Tooth-Colored Material

Cention N (Ivoclar Vivadent, Schaan, Liechtenstein)

Equia Forte HT ( GC, Tokyo, Japan) DEVICE

Glass Hybrid Restorative Material

Equia Forte HT ( GC, Tokyo, Japan)

Gradia Direct Posterior ( GC, Tokyo, Japan) DEVICE

Conventional Composite Resin

Gradia Direct Posterior ( GC, Tokyo, Japan)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Hacettepe University: lead

Study Sites (1)

Hacettepe University

Ankara, Ankara, 06100, Turkey (Türkiye)

Location

Related Publications (2)

• 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.

  PMID: 31351909 RESULT

• 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.

  PMID: 27759409 RESULT

Related Links

• Related info
• Related info
• Related info

MeSH Terms

Conditions

Dental Caries

Condition Hierarchy (Ancestors)

Tooth Demineralization; Tooth Diseases; Stomatognathic Diseases

Study Officials

• Filiz Yalçın Çakır, Prof.

  Hacettepe University

  PRINCIPAL INVESTIGATOR

• Uzay Koç Vural, Assoc. Prof.

  Hacettepe University

  PRINCIPAL INVESTIGATOR

• Kemal Işıklı

  Hacettepe University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, Research Assistant

Study Record Dates

• First Submitted: January 9, 2024
• First Posted: January 18, 2024
• Study Start: August 28, 2022
• Primary Completion: February 28, 2025
• Study Completion: February 28, 2025
• Last Updated: December 5, 2025

Record last verified: 2025-11

Locations

TU (1)