Healthy ParticipantNCT04807465
Different Modes of Universal Adhesive in Smokers and Non-Smokers
A study testing G-Premio Bond in etch&rinse mode, G-Premio Bond in selective-etch mode and G-Premio Bond in self-etch mode in people with Healthy Participant, run by Hacettepe University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Participant
- What is being tested?
- G-Premio Bond in etch&rinse mode, G-Premio Bond in selective-etch mode and G-Premio Bond in self-etch mode
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 47 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Sep 2018to 1 Jan 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Hacettepe University Faculty of Dentistry
Ankara, 06100
About this study
Official title: How Does Smoking Effect the Clinical Performance of a Universal Adhesive Used With Different Application Modes in Non Carious Cervical Lesions?
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.
Read the detailed description
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.
- Conditions
- Healthy Participant
- Being tested
- G-Premio Bond in etch&rinse mode, G-Premio Bond in selective-etch mode, G-Premio Bond in self-etch mode
- Keywords
- non-carious cervical lesions, universal adhesives, smoking
- Medical subject headings
- Smoking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
G-Premio Bond in etch&rinse modeDevice
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 modeDevice
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 modeDevice
The adhesive system was applied to the enamel and dentin surfaces.
| Study group | Role | What they receive |
|---|---|---|
| G-Premio universal adhesive used in smoker participants | Other | Participants who smoke at least 10 cigarettes per day Receives: 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 Receives: Device: G-Premio Bond in etch&rinse mode; Device: G-Premio Bond in selective-etch mode; Device: G-Premio Bond in self-etch mode |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: baseline (one week)-18-month
Post-op Hypersensitivity
It is the evaluation of sensitivity after dental treatment. Alpha: Hypersensitivity absent. Charlie: Present; clinically unacceptable.
Measured: 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.
Measured: baseline (one week)-18-month
Secondary outcomes (1)
VAS scale
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.
Measured: baseline (one week)-18-month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2021
- Study start1 Sep 2018
- Primary completion1 Mar 2021
- Study completion1 Jan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Healthy ParticipantStudies of the same condition, open and under way.
- More trials run by Hacettepe UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 47 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hacettepe University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, A Ruya Yazici, Hacettepe University
- Investigators
- A. Ruya Yazici, Principal investigator, Study Principal Investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04807465
- Sponsor's protocol ID
- interventional study
- Status last verified
- Jun 2026
- First submitted
- 13 Mar 2021
- Last updated
- 26 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Publications
Aydemir G, Gorucu J, Yazici AR. How does smoking affect the clinical performance of a universal adhesive in non-carious cervical lesions? -An 18-month randomized clinical trial. BMC Oral Health. 2026 Aug 4;26(1):1666. doi: 10.1186/s12903-026-09521-x.
PubMed 42698095
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- How Does Smoking Effect the Clinical Performance of a Universal Adhesive Used With Different Application Modes in Non Carious Cervical Lesions?
- ClinicalTrials.gov ID
- NCT04807465
- Acronym / sponsor ID
- interventional study
- Conditions
- Healthy Participant
- Keywords
- non-carious cervical lesions, universal adhesives, smoking
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 47 participants (actual)
- Lead sponsor
- Hacettepe UniversityUniversity, hospital or other
- Study start
- 1 Sep 2018 (actual)
- Primary completion
- 1 Mar 2021 (actual)
- Study completion
- 1 Jan 2028 (estimated)
- First posted
- 19 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| G-Premio universal adhesive used in smoker participants | Other | Device: G-Premio Bond in etch&rinse mode, Device: G-Premio Bond in selective-etch mode, Device: G-Premio Bond in self-etch modeParticipants who smoke at least 10 cigarettes per day |
| G-Premio universal adhesive used in non-smoker participants | Other | Device: G-Premio Bond in etch&rinse mode, Device: G-Premio Bond in selective-etch mode, Device: G-Premio Bond in self-etch modeparticipants who non-smoke have never smoked before |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (8 listed)
- Participant had fewer than 20 teeth,
- having poor oral hygiene,
- uncontrolled periodontal disease,
- xerostomia,
- diagnosis of bruxism,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| G-Premio Bond in etch&rinse modeThe 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. | Device | G-Premio universal adhesive used in non-smoker participants, G-Premio universal adhesive used in smoker participants |
| G-Premio Bond in selective-etch modeThe 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. | Device | G-Premio universal adhesive used in non-smoker participants, G-Premio universal adhesive used in smoker participants |
| G-Premio Bond in self-etch modeThe adhesive system was applied to the enamel and dentin surfaces. | Device | G-Premio universal adhesive used in non-smoker participants, G-Premio universal adhesive used in smoker participants |
Primary outcome
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.
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.
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.
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.
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.
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.
1 secondary outcome
VAS scale
Time frame: baseline (one week)-18-month
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2026.
- Derived from this study: PubMed 42698095Aydemir G, Gorucu J, Yazici AR. How does smoking affect the clinical performance of a universal adhesive in non-carious cervical lesions? -An 18-month randomized clinical trial. BMC Oral Health. 2026 Aug 4;26(1):1666. doi: 10.1186/s12903-026-09521-x.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
A. Ruya Yazici principal investigator
Study Principal Investigator
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing G-Premio Bond in etch&rinse mode, G-Premio Bond in selective-etch mode and G-Premio Bond in self-etch mode in people with Healthy Participant, run by Hacettepe University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 26 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Retention (time frame: baseline (one week)-18-month). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04807465, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jun 2026.