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CompletedNCT04095520Updated Feb 18, 2022

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

An interventional study of Laser Etching and Phosphoric acid etching in Dental Erosion, sponsored by Yuzuncu Yıl University. Completed at 1 site in Turkey. Open to participants aged 18 Years to 70 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-02-18.

Sponsored by Yuzuncu Yıl University · Not applicable, Interventional, and Other

Phase
Not applicable
Study type
Interventional
Enrollment
27
Allocation
Randomized
Ages
18 Years to 70 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Dental Erosion

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03

In context

Tooth Erosion

47 studies on the registry are indexed under Tooth Erosion; 7 are open to participants now.

This study's enrollment of 27 is below the median of 33 across 33 interventional studies indexed under Tooth Erosion.

Browse Tooth Erosion studies →

Lead sponsor

Yuzuncu Yıl University is the lead sponsor of 124 studies on the registry; 7 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
27 participants (actual)

Study arms

  • 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 · Procedure: Phosphoric acid etching

  • 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 · Procedure: Phosphoric acid etching

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.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 1st day, 1st week,6th month, 1st year

  2. 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.

    Time frame: 1st day, 1st week,6th month, 1st year

  3. 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.

    Time frame: 1st day, 1st week,6th month, 1st year

  4. 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.

    Time frame: 1st day, 1st week, 6th month, 1st year

  5. 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.

    Time frame: 1st day, 1st week, 6th month, 1st year

  6. 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.

    Time frame: 1st day, 1st week, 6th month, 1st year

  7. Evaluation the Changes of Wear

    Wear of the restorations will be evaluated and scored according to the FDI Direct Restorations Clinical Criteria Scale.

    Time frame: 1st day, 1st week, 6th month, 1st year

  8. 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.

    Time frame: 1st day, 1st week, 6th month, 1st year

  9. 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.

    Time frame: 1st day, 1st week, 6th month, 1st year

  10. 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.

    Time frame: 1st day, 1st week, 6th month, 1st year

  11. 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.

    Time frame: 1st day, 1st week, 6th month, 1st year

  12. 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.

    Time frame: 1st day, 1st week, 6th month, 1st year

07

Study locations

1 site
  • Van Yuzuncu Yil University, Faculty of Dentistry
    Van, 65100, Turkey
08

References and documents

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. PubMed 30206572 ↗
  • 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. PubMed 30120605 ↗

Individual participant data

Plan to share: Undecided

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 18, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04095520
Responsible party
Alperen Degirmenci (Assistant Professor, Yuzuncu Yıl University) — Principal investigator
First posted
Sep 19, 2019
Start date
Sep 1, 2019
Primary completion
Jan 25, 2022
Completion
Jan 25, 2022
Last update
Feb 18, 2022

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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