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

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

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.

Study Overview

• Status: Completed
• Conditions: Dental Erosion
• Intervention / Treatment: Procedure: Laser Etching; Procedure: Phosphoric acid etching

• Study Type: Interventional
• Enrollment (Actual): 27
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Van, Turkey, 65100
    • Van Yuzuncu Yil University, Faculty of Dentistry

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Paste Type Traditional Composite-GC G Aenial Anterior; Non-carious cervical lesions with shallow depth of less than 3 mm will be restored with microhybrid composite	Procedure: Laser Etching; 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.; Procedure: Phosphoric acid etching; Before the restorations, cavities will be etched with %37 phosphoric acid for 15 seconds.
Experimental: Injectable Composite- GC G Aenial Universal Injectable; Non-carious cervical lesions with shallow depth of less than 3 mm will be restored with injectable form composite	Procedure: Laser Etching; 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.; Procedure: Phosphoric acid etching; Before the restorations, cavities will be etched with %37 phosphoric acid for 15 seconds.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Yuzuncu Yıl University

Publications and helpful links

General Publications

• Celik EU, Tunac AT, Yilmaz F. A Randomized, Controlled, Split-mouth Trial Evaluating the Clinical Performance of High-viscosity Glass-ionomer Restorations in Noncarious Cervical Lesions: Two-year Results. J Adhes Dent. 2018;20(4):299-305. doi: 10.3290/j.jad.a40985.
• Celik EU, Tunac AT, Yilmaz F. Three-year clinical evaluation of high-viscosity glass ionomer restorations in non-carious cervical lesions: a randomised controlled split-mouth clinical trial. Clin Oral Investig. 2019 Mar;23(3):1473-1480. doi: 10.1007/s00784-018-2575-y. Epub 2018 Aug 17.

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2019
• Primary Completion (Actual): January 25, 2022
• Study Completion (Actual): January 25, 2022

Study Registration Dates

• First Submitted: September 11, 2019
• First Submitted That Met QC Criteria: September 16, 2019
• First Posted (Actual): September 19, 2019

Study Record Updates

• Last Update Posted (Actual): February 18, 2022
• Last Update Submitted That Met QC Criteria: February 17, 2022
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Stomatognathic Diseases; Tooth Diseases; Tooth Wear; Tooth Erosion
• Other Study ID Numbers: 15/ 06.08.2019

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No