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

NCT ID: NCT04095520

Last Updated: 2022-02-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 27 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-09-01
• Study Completion Date: 2022-01-25

Brief Summary

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.

Conditions

Dental Erosion

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

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

Group Type: ACTIVE_COMPARATOR

Laser Etching

Intervention Type: PROCEDURE

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.

Phosphoric acid etching

Intervention Type: PROCEDURE

Before the restorations, cavities will be etched with %37 phosphoric acid for 15 seconds.

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

Group Type: EXPERIMENTAL

Laser Etching

Intervention Type: PROCEDURE

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.

Phosphoric acid etching

Intervention Type: PROCEDURE

Before the restorations, cavities will be etched with %37 phosphoric acid for 15 seconds.

Interventions

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.

Intervention Type: PROCEDURE

Phosphoric acid etching

Before the restorations, cavities will be etched with %37 phosphoric acid for 15 seconds.

Intervention Type: PROCEDURE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Yuzuncu Yıl University

OTHER

Sponsor Role: lead

Responsible Party

Alperen Degirmenci

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Van Yuzuncu Yil University, Faculty of Dentistry

Van, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

References

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.

Reference Type: RESULT

PMID: 30206572 (View on PubMed)

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.

Reference Type: RESULT

PMID: 30120605 (View on PubMed)

Other Identifiers

15/ 06.08.2019

Identifier Type: -

Identifier Source: org_study_id