Different Modes of Universal Adhesive in Smokers and Non-Smokers

NCT04807465 | Unknown

• 1 other identifier: interventional study
• Study Type: interventional
• Target: 47
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Healthy Participant

Keywords

non-carious cervical lesions; universal adhesives; smoking

Outcome Measures

Primary Outcomes (6)

• Retention

  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.

  baseline (one week)-18-month

• Marginal Discoloration

  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.

  baseline (one week)-18-month

• Marginal Adaptation

  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.

  baseline (one week)-18-month

• Color match

  Evaluating whether the restoration and adjacent tooth tissue color is compatible. Alpha:Matches tooth. Bravo: Acceptable mismatch. Charlie:Unacceptable mismatch.

  baseline (one week)-18-month

• Post-op Hypersensitivity

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

  baseline (one week)-18-month

• Secondary Caries

  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.

  baseline (one week)-18-month

Secondary Outcomes (1)

• VAS scale

  baseline (one week)-18-month

Other Outcomes (2)

• Plaque Index

  baseline (one week)-18-month

• Gingival index

  baseline (one week)-18-month

Study Arms (2)

G-Premio universal adhesive used in smoker participants

OTHER

Participants who smoke at least 10 cigarettes per day

Device: G-Premio Bond in etch&rinse mode; Device: G-Premio Bond in selective-etch mode; Device: G-Premio Bond in self-etch mode

G-Premio universal adhesive used in non-smoker participants

OTHER

participants who non-smoke have never smoked before

Device: G-Premio Bond in etch&rinse mode; Device: G-Premio Bond in selective-etch mode; Device: G-Premio Bond in self-etch mode

Interventions

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 universal adhesive used in non-smoker participants; G-Premio universal adhesive used in smoker participants

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 universal adhesive used in non-smoker participants; G-Premio universal adhesive used in smoker participants

G-Premio Bond in self-etch mode DEVICE

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

G-Premio universal adhesive used in non-smoker participants; G-Premio universal adhesive used in smoker participants

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hacettepe University: lead

Study Sites (1)

Hacettepe University Faculty of Dentistry

Ankara, 06100, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Smoking

Condition Hierarchy (Ancestors)

Behavior

Study Officials

• A. Ruya Yazici

  Study Principal Investigator

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor

Model Details: 47 participants having at least three non-carious cervical lesions were included in the study. Participants were divided into two groups as smokers and non-smokers. Before treatment, the dimensions and depth of the lesions were measured with periodontal probe and the sensitivity of each tooth was determined using VAS scale. All of the non-carious cervical lesions were restored with a resin composite, Essentia,GC using one of three different application modes of universal adhesive, G-Premio Bond (etch\&rinse, selective-etch, self-etch). The restorations were placed by a single operator. Two calibrated examiners who were fully blind to restorative procedure evaluated the restorations in terms of retention, marginal discoloration, marginal adaptation, color match, postoperative sensitivity and secondary caries using modified USPHS criteria. The plaque and gingival index were also asessed at baseline and every 6 months of clinical service for 18 months.

Study Record Dates

• First Submitted: March 13, 2021
• First Posted: March 19, 2021
• Study Start: September 1, 2018
• Primary Completion: March 1, 2021
• Study Completion: January 1, 2025
• Last Updated: March 23, 2021

Record last verified: 2021-03

Locations

TU (1)