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NCT Number: NCT04807465

Different Modes of Universal Adhesive in Smokers and Non-Smokers

The aim of the study was to evaluate the influence of smoking on the clinical performance of a universal adhesive used with different application modes in non-carious cervical lesions.

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Key information

Conditions

Healthy Participant Behavior Smoking

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hacettepe University Faculty of Dentistry

Ankara, 06100, Turkey (Türkiye)

About this study

Forty-seven patients (having at least three noncarious cervical lesions) were participated in this study. After allocation of patients into 2 groups according to their smoking habits (non-smokers; 24, smokers;23), lesions in each patient were restored with a resin composite, (Essentia, GC) using a universal adhesive G-Premio Bond and phosphoric acid (i-Dental) in three different application modes (etch&rinse, selective-etch or self-etch). The restorative treatments were performed by single operator. Two experienced and calibrated examiners evaluated the restorations for retention, marginal discoloration, marginal adaptation, color match, postoperative sensitivity and secondary caries at one week (baseline), at 6-, 12, and 18 months using modified USPHS criteria.While the USPHS criteria measure the clinical performance of the restorative material, it scores according to three different degrees;Alpha:The restoration is clinically perfect. Bravo:All features of the restoration are sufficient, need not be renewed. Charlie: the restoration is clinically unsuccessful, unacceptable. The gingival and plaque index were also assessed with a periodontal probe.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Patients were 18 years of age or older,
  • good general health,
  • acceptable oral hygiene level,
  • no possible health problems (such as allergies) related to resin-based restorations,
  • at least three non-carious cervical lesions with at least 20 teeth in the occlusion.
  • The depth of the lesions should be at least 1 mm, without carious, not previously restored, having teeth with vital, enamel and dentin tissue.
  • Patients who smoke at least 10 cigarettes per day, however patients in non-smokers have never smoked before.

Exclusion criteria

  • Participant had fewer than 20 teeth,
  • having poor oral hygiene,
  • uncontrolled periodontal disease,
  • xerostomia,
  • diagnosis of bruxism,
  • pregnancy or breastfeeding possible health problems (such as allergy) related to resin-based restorations
  • having severe systemic disease,
  • having bleaching treatment or orthodontic treatment.

Treatment and study plan

G-Premio Bond in etch&rinse mode

Device

The phosphoric acid gel was applied to enamel and dentin washed for 5s and was dried gently with air spray. The adhesive system was applied to enamel and dentin surfaces and leave it in place for 10s.

G-Premio Bond in selective-etch mode

Device

The phosphoric acid was applied only on enamel for 10-15s then washed and was gently dried with air spray. The adhesive system was applied to enamel and dentin surfaces.

G-Premio Bond in self-etch mode

Device

The adhesive system was applied to the enamel and dentin surfaces.

Primary outcomes

  1. Retention

    Time frame: baseline (one week)-18-month

    According to the usphs criteria, retention indicates whether a restorative material is functional in the oral environment, and is the most important criterion by which we can evaluate the success of the material.

    Alpha: Retained. Charlie: Mobile or missing; clinically unacceptable.

  2. Marginal Discoloration

    Time frame: baseline (one week)-18-month

    Evaluation of color changes in restoration margins and linear staining along restoration margins. Alfa: No discoloration along the margin. Bravo: Slight and superficial staining (removable, usually localized). Charlie: Deep staining cannot be polished away.

  3. Marginal Adaptation

    Time frame: baseline (one week)-18-month

    The marginal adaptation criterion evaluates the complete achievement of tooth-restoration integrity.

    Alpha: Undetectable. Bravo: Visible evidence of a crevice along the margin, dentin not exposed, clinically acceptable.

    Charlie: Explorer penetrates into crevice, dentin is exposed; clinically unacceptable.

  4. Color match

    Time frame: baseline (one week)-18-month

    Evaluating whether the restoration and adjacent tooth tissue color is compatible.

    Alpha:Matches tooth. Bravo: Acceptable mismatch. Charlie:Unacceptable mismatch.

  5. Post-op Hypersensitivity

    Time frame: baseline (one week)-18-month

    It is the evaluation of sensitivity after dental treatment. Alpha: Hypersensitivity absent. Charlie: Present; clinically unacceptable.

  6. Secondary Caries

    Time frame: baseline (one week)-18-month

    In this criterion, the dark colored area that occurs under the tooth tissue surface and in the tooth tissue adjacent to the restoration is defined as caries.

    Alpha: Caries absent. Charlie: Present; clinically unacceptable.

Secondary outcomes

  1. VAS scale

    Time frame: baseline (one week)-18-month

    Sensitivity to air was assessed by appling a stream of compressed air for three second 1 cm away from the tooth surface while shielding the neighboring teeth with the fingers. After this application, individuals are asked to evaluate the sensitivity of the tooth according to the Visual Analog Scale (VAS). VAS consists of a straight line 10 centimeters (cm) long. The left end of the line is 0 and it means "no pain, the right end is 10", meaning unbearable pain. With the help of this scale, the pain levels in the teeth of individuals with hypersensitivity can be determined.

Other outcomes

  1. Plaque Index

    Time frame: baseline (one week)-18-month

    When evaluating Plaque Index scores, only the amount of plaque in the gingival area of the tooth surfaces is taken into account. Plaque amount is evaluated with periodontal probe and scored.

    Plaque Index Scores 0 When examined with a periodontal probe at the edge of the gum, no plaque accumulation is seen.

    • When examined with a periodontal probe, it is seen that there is plaque accumulation.
    • Visible plaque accumulation at the edge of the gum but not completely filled in the interdental area.
    • An easily visible plaque accumulation on the gum edge and towards the coronal, completely filling the interdental zone

  2. Gingival index

    Time frame: baseline (one week)-18-month

    The periodontal probe is used to evaluate whether there is inflammation, discoloration, and gingival bleeding along the gingival sulcus.

    Gingival Index Scores 0 Healthy gums.

    • Mild inflammation: Slight discoloration and mild edema, but no bleeding on probing.
    • Moderate inflammation: The gingiva is shiny, there is slight redness, edema and bleeding on the gum when touched with the sond.
    • Severe inflammation: There is marked redness, edema and ulceration of the gums, the gum tends to bleed spontaneously.

Sponsors and collaborators

Lead sponsor

Hacettepe University

Other

Registry information

Official study title

How Does Smoking Effect the Clinical Performance of a Universal Adhesive Used With Different Application Modes in Non Carious Cervical Lesions?

Important dates

Study start
2018
Primary completion
2021
Study completion
2028
First posted
Mar 19, 2021
Registry last updated
Jun 26, 2026

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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