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

Not Applicable

Completed

• Conditions: Dental Erosion
• Interventions: Procedure: Laser Etching; Procedure: Phosphoric acid etching

• Registration Number: NCT04095520
• Lead Sponsor: Yuzuncu Yıl University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-09-01
• Study First Submitted: 2019-09-11
• Study First Submitted QC: 2019-09-16
• Study First Posted: 2019-09-19
• Primary Completion: 2022-01-25
• Study Completion: 2022-01-25
• Status Verified: 2022-02
• Last Update Submitted: 2022-02-17
• Last Update Posted: 2022-02-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 27

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Injectable Composite- GC G Aenial Universal Injectable	Phosphoric acid etching	Non-carious cervical lesions with shallow depth of less than 3 mm will be restored with injectable form composite
Injectable Composite- GC G Aenial Universal Injectable	Laser Etching	Non-carious cervical lesions with shallow depth of less than 3 mm will be restored with injectable form composite
Paste Type Traditional Composite-GC G Aenial Anterior	Laser Etching	Non-carious cervical lesions with shallow depth of less than 3 mm will be restored with microhybrid composite
Paste Type Traditional Composite-GC G Aenial Anterior	Phosphoric acid etching	Non-carious cervical lesions with shallow depth of less than 3 mm will be restored with microhybrid composite

Primary Outcome Measures

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

Trial Locations

Locations (1)

Van Yuzuncu Yil University, Faculty of Dentistry; 🇹🇷 Van, Turkey