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Completed

NCT Number: NCT03932929

36-Month Clinical Evaluation of a Universal Adhesive

The aim of this clinical trial was to evaluate and compare the performance of a universal adhesive with different adhesive strategies in the restoration of non-carious cervical lesions (NCCLs) over a 36-month period.

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Key information

Conditions

Non-carious Cervical Lesions

Age range

18 year–81 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hacettepe University

Ankara, 06100, Turkey (Türkiye)

About this study

One hundred sixty-five NCCLs in 35 patients (13 female, 22 male) with at least 3 lesions were included in this study. Three groups were formed according to adhesive strategies used (n=55): selective-etch mode; etch-and-rinse mode (ER); or self-etch (SE) mode of a universal adhesive, Single Bond Universal. The same nanofilled resin composite, Filtek Ultimate was used for all restorations by a single operator. The restorations were evaluated by two calibrated examiners at baseline and at 6-, 12-, 18-, 24- and 36- months in accordance with the modified USPHS criteria. The Chi-square test was used for intergroup, the Cochran Q test was used for intragroup comparison.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • over 18 years old
  • good oral hygiene
  • available for recall
  • at least 20 teeth under occlusion
  • the presence of at least three non-carious cervical lesions

Exclusion criteria

  • poor oral hygiene
  • bruxism habits
  • severe or chronic periodontitis
  • If the teeth selected for study, were nonvital, or had any restorations on other surfaces were not included.

Treatment and study plan

Scotchbond Universal Adhesive (3M ESPE)

Device

Adhesive system

Primary outcomes

  1. Marginal adaptation

    Time frame: From baseline to 36 month

    Observers evaluated the restorations was performed using the modified United State Public Health Service criteria regarding marginal adaptation. Marginal adaptation was evaluated by 2 independent clinicians. Visual inspection with a mirror was performed . Scores; Alfa: Closely adapted, no visible crevice. Bravo: Visible crevice, explorer will penetrate. Charlie: Crevice in which dentin is exposed

  2. Marginal staining

    Time frame: From baseline to 36 month

    Observers evaluated the restorations was performed using the modified United State Public Health Service criteria regarding marginal staining. Marginal staining was evaluated by 2 independent clinicians. Visual inspection with a mirror was performed . Scores: Alfa: No discoloration. Bravo: Discoloration without. Charlie: Discoloration with penetration in pulpal direction

  3. Retention

    Time frame: From baseline to 36 month

    Observers evaluated the restorations was performed using the modified United State Public Health Service criteria regarding retention rate. Retention rate was evaluated by 2 independent clinicians. Scores: Alfa: No loss of restorative material. Charlie: Any loss of restorative material

  4. Postoperative sensitivity

    Time frame: From baseline to 36 month

    Observers evaluated the restorations was performed using the modified United State Public Health Service criteria regarding retention rate. Retention rate was evaluated by 2 independent clinicians. Scores: Alfa: Not present. Bravo: sensitive but diminishing in intensity. Charlie:constant sensitivity, not diminishing in intensity

  5. Seconder caries

    Time frame: From baseline to 36 month

    Observers evaluated the restorations was performed using the modified United State Public Health Service criteria regarding retention rate. Retention rate was evaluated by 2 independent clinicians. Scores: Alfa: No caries present. Charlie: Caries present

Sponsors and collaborators

Lead sponsor

Hacettepe University

Other

Registry information

Official study title

36-Month Clinical Evaluation of Different Adhesive Strategies of a Universal Adhesive

Important dates

Study start
2015
Primary completion
2018
Study completion
2018
First posted
May 1, 2019
Registry last updated
May 6, 2019

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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