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NCT Number: NCT04095520

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

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.

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Key information

Conditions

Dental Erosion Stomatognathic Diseases Tooth Demineralization Tooth Diseases Tooth Erosion Tooth Wear

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Van Yuzuncu Yil University, Faculty of Dentistry

Van, 65100, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Laser Etching

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

Procedure

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

Primary outcomes

  1. Evaluation the Changes of Surface Luster

    Time frame: 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.

  2. Evaluation the Changes of Retention

    Time frame: 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.

  3. Evaluation the Changes of Surface Staining

    Time frame: 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.

  4. Evaluation the Changes of Color Stability and Translucency

    Time frame: 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.

  5. Evaluation the Changes of Anatomic Form

    Time frame: 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.

  6. Evaluation the Changes of Marginal Adaptation

    Time frame: 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.

  7. Evaluation the Changes of Wear

    Time frame: 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.

  8. Evaluation the Changes of Patients View

    Time frame: 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.

  9. Evaluation the Changes of Postoperative (hyper-)sensitivity and tooth vitality

    Time frame: 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.

  10. Evaluation the Changes of Recurrence of Caries, Erosion, Abfraction

    Time frame: 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.

  11. Evaluation the Changes of Tooth integrity

    Time frame: 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.

  12. Evaluation the Changes of Periodontal response

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Yuzuncu Yil University

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2022
Study completion
2022
First posted
Sep 19, 2019
Registry last updated
Feb 18, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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