Skip to content

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04095520
Enrollment
27
Registered
2019-09-19
Start date
2019-09-01
Completion date
2022-01-25
Last updated
2022-02-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dental Erosion

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.

Interventions

PROCEDURELaser 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.

PROCEDUREPhosphoric acid etching

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

Sponsors

Yuzuncu Yil University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Evaluation the Changes of Surface Luster1st day, 1st week,6th month, 1st yearSurface luster of the restorations will be evaluated and scored according to the FDI Direct Restorations Clinical Criteria Scale.
Evaluation the Changes of Retention1st day, 1st week,6th month, 1st yearFractures and retention of the restorations will be evaluated and scored according to the FDI Direct Restorations Clinical Criteria Scale.
Evaluation the Changes of Surface Staining1st day, 1st week,6th month, 1st yearSurface staining of the restorations will be evaluated and scored according to the FDI Direct Restorations Clinical Criteria Scale.
Evaluation the Changes of Color Stability and Translucency1st day, 1st week, 6th month, 1st yearColor Stability and translucency of the restorations will be evaluated and scored according to the FDI Direct Restorations Clinical Criteria Scale.
Evaluation the Changes of Anatomic Form1st day, 1st week, 6th month, 1st yearAnatomic form of the restorations will be evaluated and scored according to the FDI Direct Restorations Clinical Criteria Scale.
Evaluation the Changes of Marginal Adaptation1st day, 1st week, 6th month, 1st yearMarginal adaptation of the restorations will be evaluated and scored according to the FDI Direct Restorations Clinical Criteria Scale.
Evaluation the Changes of Wear1st day, 1st week, 6th month, 1st yearWear of the restorations will be evaluated and scored according to the FDI Direct Restorations Clinical Criteria Scale.
Evaluation the Changes of Patients View1st day, 1st week, 6th month, 1st yearPatients view of the restorations will be evaluated and scored according to the FDI Direct Restorations Clinical Criteria Scale.
Evaluation the Changes of Postoperative (hyper-)sensitivity and tooth vitality1st day, 1st week, 6th month, 1st yearPostoperative (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 Recurrence of Caries, Erosion, Abfraction1st day, 1st week, 6th month, 1st yearRecurrence 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 Tooth integrity1st day, 1st week, 6th month, 1st yearTooth integrity of the restorations will be evaluated and scored according to the FDI Direct Restorations Clinical Criteria Scale.
Evaluation the Changes of Periodontal response1st day, 1st week, 6th month, 1st yearPeriodontal response of the restorations will be evaluated and scored according to the FDI Direct Restorations Clinical Criteria Scale.

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026