12 Months Clinical Follow-up of Non-Carious Cervical Lesions Restored With New Injectable Composite

Study Overview
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Brief Summary
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Non-carious cervical lesions are defined as loss of pathological material not associated with caries in the enamel-cement junction of the tooth. The etiology of these lesions has been defined as brush abrasion, acid-induced erosion and abstraction due to microstructure losses due to stress concentration in a particular region of the tooth. These lesions should be restored using minimally invasive techniques. The necessity of restorative treatment is directly related to the size of the lesion, sensitivity and aesthetic requirements. However, restorative procedures are often challenging because the cavity preparation does not provide adequate retention, and often the cervical end margin is positioned under the gingiva. This leads to contamination of the operation site with blood, saliva and gingival fluid. Several restorative options have been proposed for the treatment of cervical caries-free lesions. However, due to their high aesthetic properties, improved adhesive capacity and mechanical properties, composites have been accepted as the most suitable choice. Clinical studies have demonstrated that marginal adaptation, marginal discoloration, and roughening methods for retention are the most important factors in the clinical performances of composite restorations in cervical lesions. Therefore, injectable composites with wettability and better adaptability to cavity margins have been introduced. However, the low filler contents of fluid composites and their weak mechanical properties compared to conventional composites have led researchers to doubt their use in caries-free cervical lesions. As a result of the developed material technology, injectable composites with high filler which have reduced polymerization shrinkage have been developed with simplified filler procedure. However, investigators have not encountered any studies investigating which etching technique this material will exhibit better clinical performance and comparing it with traditional pasty composites. The aim of this study is to evaluate the clinical performance of traditional paste type and injectable composites which will be made by using two different etching techniques.

Official Title
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Non-Carious Cervical Lesions Restored With Different Etching Methods and New Injectable Composite: One Year Clinical Follow-Up

Conditions
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Dental Erosion

Intervention / Treatment
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* Procedure: Laser Etching
* Procedure: Phosphoric acid etching


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with cervical lesions in the mouth with multiples of 4 and 4, Patients over 18 years of age and in permanent dentition, Patients who do not have a pulpal or endodontic lesion on their teeth to be treated, Patients without sensitivity to percussion in the teeth to be treated. Exclusion Criteria: Patients with any systemic disease, Pregnant or suspected pregnancy and also breastfeeding patients, Patients who are allergic to any dental material, Patients with any periodontal disease, Patients with poor oral hygiene, In cases where the teeth are exposed to excessive load due to excessive rupture, Cervical caries lesions, Patients who continue orthodontic treatment, Desensitizing agents or fluoride treatment.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Paste Type Traditional Composite-GC G Aenial Anterior<br>Non-carious cervical lesions with shallow depth of less than 3 mm will be restored with microhybrid composite | Procedure: Laser Etching<br>* Before the restorations, cavities will be etched Er:Cr YSGG laser with 4W output power, water pressure 95% and air pressure 60% with MGG6 tip with the spot size of 600 µm will be used.<br>Procedure: Phosphoric acid etching<br>* Before the restorations, cavities will be etched with %37 phosphoric acid for 15 seconds.<br>|
| Experimental: Injectable Composite- GC G Aenial Universal Injectable<br>Non-carious cervical lesions with shallow depth of less than 3 mm will be restored with injectable form composite | Procedure: Laser Etching<br>* Before the restorations, cavities will be etched Er:Cr YSGG laser with 4W output power, water pressure 95% and air pressure 60% with MGG6 tip with the spot size of 600 µm will be used.<br>Procedure: Phosphoric acid etching<br>* Before the restorations, cavities will be etched with %37 phosphoric acid for 15 seconds.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation the Changes of Surface Luster | Surface luster of the restorations will be evaluated and scored according to the FDI Direct Restorations Clinical Criteria Scale. | 1st day, 1st week,6th month, 1st year | 
| Evaluation the Changes of Retention | Fractures and retention of the restorations will be evaluated and scored according to the FDI Direct Restorations Clinical Criteria Scale. | 1st day, 1st week,6th month, 1st year | 
| Evaluation the Changes of Surface Staining | Surface staining of the restorations will be evaluated and scored according to the FDI Direct Restorations Clinical Criteria Scale. | 1st day, 1st week,6th month, 1st year | 
| Evaluation the Changes of Color Stability and Translucency | Color Stability and translucency of the restorations will be evaluated and scored according to the FDI Direct Restorations Clinical Criteria Scale. | 1st day, 1st week, 6th month, 1st year | 
| Evaluation the Changes of Anatomic Form | Anatomic form of the restorations will be evaluated and scored according to the FDI Direct Restorations Clinical Criteria Scale. | 1st day, 1st week, 6th month, 1st year | 
| Evaluation the Changes of Marginal Adaptation | Marginal adaptation of the restorations will be evaluated and scored according to the FDI Direct Restorations Clinical Criteria Scale. | 1st day, 1st week, 6th month, 1st year | 
| Evaluation the Changes of Wear | Wear of the restorations will be evaluated and scored according to the FDI Direct Restorations Clinical Criteria Scale. | 1st day, 1st week, 6th month, 1st year | 
| Evaluation the Changes of Patients View | Patients view of the restorations will be evaluated and scored according to the FDI Direct Restorations Clinical Criteria Scale. | 1st day, 1st week, 6th month, 1st year | 
| Evaluation the Changes of Postoperative (hyper-)sensitivity and tooth vitality | Postoperative (hyper-)sensitivity and tooth vitality of the restorations will be evaluated and scored according to the FDI Direct Restorations Clinical Criteria Scale. | 1st day, 1st week, 6th month, 1st year | 
| Evaluation the Changes of Recurrence of Caries, Erosion, Abfraction | Recurrence of Caries, Erosion, Abfraction of the restorations will be evaluated and scored according to the FDI Direct Restorations Clinical Criteria Scale. | 1st day, 1st week, 6th month, 1st year | 
| Evaluation the Changes of Tooth integrity | Tooth integrity of the restorations will be evaluated and scored according to the FDI Direct Restorations Clinical Criteria Scale. | 1st day, 1st week, 6th month, 1st year | 
| Evaluation the Changes of Periodontal response | Periodontal response of the restorations will be evaluated and scored according to the FDI Direct Restorations Clinical Criteria Scale. | 1st day, 1st week, 6th month, 1st year |