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

Caries,Dental Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT06211582
• Other study ID #: KA-22015
• Status: Active, not recruiting
• Phase: N/A
• Start date: September 15, 2022
• Est. completion date: March 20, 2024

Study information

• Verified date: January 2024
• Source: Hacettepe University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 47
• Est. completion date: March 20, 2024
• Est. primary completion date: June 15, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Caries,Dental
• Dental Caries

Intervention

Device:
• Cention N (Ivoclar Vivadent, Schaan, Liechtenstein)
The Alkasite-Based Tooth-Colored Material
• Equia Forte HT ( GC, Tokyo, Japan)
Glass Hybrid Restorative Material
• Gradia Direct Posterior ( GC, Tokyo, Japan)
Conventional Composite Resin

Locations

Country	Name	City	State
Turkey	Hacettepe University	Ankara

Sponsors (1)

Lead Sponsor	Collaborator
Hacettepe University

Country where clinical trial is conducted

Turkey, 

References & Publications (2)

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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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

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