Healthy ParticipantNCT04814836

Laser Etching Effect on Application Mode of Universal Adhesive

A study testing Total-etch mode with 35% phosphoric acid (K-ETCHANT) (TE-A group), Selective-etch mode with 35% phosphoric acid (K-ETCHANT) (SE-A group) and Total-etch mode with Er, Cr: YSGG laser (Waterlase MD) (TE-L group) in people with Healthy Participant, run by Hacettepe University at 1 site in Turkey (Türkiye).

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record

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Trial summary

To evaluate the clinical performance of the restorations by applying the universal adhesive in different modes under the influence of different surface treatments, with Erbium Chromium:Yttrium-Scandium-Gallium-Garnet (Er,Cr:YSGG) laser and acid etching 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?: Total-etch mode with 35% phosphoric acid (K-ETCHANT) (TE-A group), Selective-etch mode with 35% phosphoric acid (K-ETCHANT) (SE-A group) and Total-etch mode with Er, Cr: YSGG laser (Waterlase MD) (TE-L group)
Type of treatment: Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 41 participants
Where: 1 siteTurkey (Türkiye)
Study dates: 10 Jul 2019to 25 Mar 2025
Phase: Interventional
Are there results?: None posted in the registry

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

Participants were 18 years of age or older,
no possible health problems (such as allergies) related to resin-based restorations,
good general health,
having at least five non-carious cervical lesions.
The depth of the lesions were at least 1 mm, without carious, not previously restored, having teeth with vital, enamel and dentin tissue.

Who cannot join

Participant had fewer than 20 teeth,
having poor oral hygiene,
uncontrolled periodontal disease,
xerostomia,
pregnancy or breastfeeding possible health problems (such as allergy) related to resin-based restorations,
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

Other trials in Turkey (Türkiye)

About this study

Official title: Clinical Evaluation of Cervical Composite Restorations Placed Using Universal Adhesive in Different Modes and Different Etching Methods

Read the detailed description

Forty-one patients (at least five non-carious cervical lesions) have participated in this study. The non-carious cervical lesions in each patient were divided into five groups (total-etch mode with phosphoric acid, selective-etch mode with phosphoric acid, total-etch mode with laser, selective-etch mode with laser and self-etch mode) according to different modes and application methods of universal adhesive (Clearfil Universal Bond Quick, Kuraray). Lesions were restored with a resin composite, Clearfil Majesty ES-2 (Kuraray). All restorative procedures were performed by a single operator. Restorations were evaluated at one week (baseline), at 6-, 12-, 18- and 24-month according to modified USPHS criteria (retention, marginal discoloration, marginal adaptation, color match, postoperative sensitivity, and secondary caries) by two experienced and calibrated investigators.

Conditions: Healthy Participant
Being tested: Total-etch mode with 35% phosphoric acid (K-ETCHANT) (TE-A group), Selective-etch mode with 35% phosphoric acid (K-ETCHANT) (SE-A group), Total-etch mode with Er, Cr: YSGG laser (Waterlase MD) (TE-L group), Selective-etch mode with Er, Cr: YSGG laser (Waterlase MD) (SE-L group)., Self-etch mode Clearfil Universal Bond Quick (Kuraray, Japan) (SE group)
Keywords: non-carious cervical lesions, universal adhesives, laser etching

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Total-etch mode with 35% phosphoric acid (K-ETCHANT) (TE-A group)Procedure or surgery
35% phosphoric acid was applied to enamel and dentin for 10 s, washed and dried for 5 s. The universal adhesive, Clearfil Universal Bond Quick (CBQ) was applied to enamel and dentin surfaces with a single-use applicator, then gently air-dried for 5 s without waiting, and light-cured for 10 s.
Selective-etch mode with 35% phosphoric acid (K-ETCHANT) (SE-A group)Procedure or surgery
35% phosphoric acid was used only on enamel for 10 s, then washed and dried for 5 seconds. Subsequently, the adhesive was applied in a similar manner to the TE-A group.
Total-etch mode with Er, Cr: YSGG laser (Waterlase MD) (TE-L group)Procedure or surgery
the enamel margin and dentin surfaces of lesions were irradiated with an Er,Cr:YSGG laser (2780 nm, Waterlase MD, BioLase Technology, Inc., San Clemente, CA). Then the adhesive was applied in a similar manner to the TE-A group.
Selective-etch mode with Er, Cr: YSGG laser (Waterlase MD) (SE-L group).Procedure or surgery
The laser system was applied in the same way as described in the TE-L group only on enamel surface. Subsequently, the adhesive was applied in the same way as described in the TE-A group.
Self-etch mode Clearfil Universal Bond Quick (Kuraray, Japan) (SE group)Procedure or surgery
Universal adhesive system (CBQ) was applied to enamel and dentin surfaces without any previous etching. Then gently air-dried for 5 s without waiting, and light-cured for 10 s.

Study groups in NCT04814836
Study group	Role	What they receive
Group I	Other	Total-etch mode with 35% phosphoric acid Receives: Procedure: Total-etch mode with 35% phosphoric acid (K-ETCHANT) (TE-A group)
Group II	Other	Selective-etch mode with 35% phosphoric acid Receives: Procedure: Selective-etch mode with 35% phosphoric acid (K-ETCHANT) (SE-A group)
Group III	Other	Total-etch mode with laser (Er,Cr:YSGG) Receives: Procedure: Total-etch mode with Er, Cr: YSGG laser (Waterlase MD) (TE-L group)
Group IV	Other	Selective-etch mode with laser (Er,Cr:YSGG) Receives: Procedure: Selective-etch mode with Er, Cr: YSGG laser (Waterlase MD) (SE-L group).
Group V	Other	Self-etch mode Receives: Procedure: Self-etch mode Clearfil Universal Bond Quick (Kuraray, Japan) (SE group)

What is being measured

The primary outcome is the main question the study is designed to answer.

Retention,
The retention criterion determines how long a restorative material functions in the oral environment, it is the most important criterion that shows the success of the material.
Alpha: The restoration is present. Charlie: The restoration is absent.
Measured: From baseline to 2 year the change of restorations was evaluated
Marginal Discoloration
The marginal discoloration that occur at the edge staining restoration boundaries are generally thought to be due to microleakage.
Alpha: No discoloration at margins. Bravo: Shallow discoloration, clinically acceptable. Charlie: Deep discoloration clinically unacceptable.
Measured: From baseline to 2 year the change of restorations was evaluated
Marginal Adaptation
Marginal adaptation is achieved by fully ensuring the integrity of the tooth-restoration joint border.
Alpha: Restoration is closely adapted to the tooth. 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: From baseline to 2 year the change of restorations was evaluated
Color match
Color match is the evaluation of the restoration according to the darkening or lightening of the color, taking into account the tooth tissue surrounding restoration.
Alpha:Matches tooth. Bravo: Acceptable mismatch. Charlie:Unacceptable mismatch.
Measured: From baseline to 2 year the change of restorations was evaluated
Post-op Hypersensitivity
Determination of sensitivity after restorations are placed. Alpha: Absent. Charlie: Present; clinically unacceptable.
Measured: From baseline to 2 year the change of restorations was evaluated
Secondary Caries
Secondary caries is the progression of caries in the tooth tissue adjacent to the restorations. Caries formation means restoration failure.
Alpha: Absent. Charlie: Present; clinically unacceptable.
Measured: From baseline to 2 year the change of restorations was evaluated

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

10 Jul 201925 Mar 2025

First posted24 Mar 2021
Study start10 Jul 2019
Primary completion10 Jan 2021
Study completion25 Mar 2025 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (2)Papers the sponsor has linked to this study.
Other trials for Healthy ParticipantStudies of the same condition, open and under way.
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: This study was carried out to investigate different etching methods used for application modes of universal adhesive on clinical performance of non-carious cervical lesions. The 35% phosphoric acid (K-ETCHANT) or Er,Cr:YSGG laser (2780 nm, Waterlase MD, BioLase Technology, Inc.) etching was applied to the tooth before these application modes in order to bond the universal adhesive, Clearfil Universal Bond Quick. Accordingly, the restorations were completed with 5 different application methods to five different teeth. The allocation of etching method and application mode on each tooth was determined in an order that was assigned by Biostatistics Department. This randomization was blinded to participants and evaluators. It was not known which etching method and application mode was applied to which teeth of the participants.
Masking: None (open label)
Enrolment: 41 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04814836
Sponsor's protocol ID: KA180076
Status last verified: Mar 2021
First submitted: 11 Mar 2021
Last updated: 26 Mar 2021
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

Publications

Atalay C, Uslu A, Yazici AR. Does laser etching have an effect on application mode of a universal adhesive?-A microleakage and scanning electron microscopy evaluation. Microsc Res Tech. 2021 Jan;84(1):125-132. doi: 10.1002/jemt.23573. Epub 2020 Aug 27.
PubMed 32852126
Atalay C, Ozgunaltay G, Yazici AR. Thirty-six-month clinical evaluation of different adhesive strategies of a universal adhesive. Clin Oral Investig. 2020 Apr;24(4):1569-1578. doi: 10.1007/s00784-019-03052-2. Epub 2019 Aug 30.
PubMed 31468262

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Healthy Participant trials

Study at a glance

From the registry record, last updated by the sponsor on 26 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Clinical Evaluation of Cervical Composite Restorations Placed Using Universal Adhesive in Different Modes and Different Etching Methods
ClinicalTrials.gov ID: NCT04814836
Acronym / sponsor ID: KA180076
Conditions: Healthy Participant
Keywords: non-carious cervical lesions, universal adhesives, laser etching
Study type: Interventional
Recruitment status: Unknown status
Enrolment: 41 participants (actual)
Lead sponsor: Hacettepe UniversityUniversity, hospital or other
Study start: 10 Jul 2019 (actual)
Primary completion: 10 Jan 2021 (actual)
Study completion: 25 Mar 2025 (estimated)
First posted: 24 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.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 5
Model description: This study was carried out to investigate different etching methods used for application modes of universal adhesive on clinical performance of non-carious cervical lesions. The 35% phosphoric acid (K-ETCHANT) or Er,Cr:YSGG laser (2780 nm, Waterlase MD, BioLase Technology, Inc.) etching was applied to the tooth before these application modes in order to bond the universal adhesive, Clearfil Universal Bond Quick. Accordingly, the restorations were completed with 5 different application methods to five different teeth. The allocation of etching method and application mode on each tooth was determined in an order that was assigned by Biostatistics Department. This randomization was blinded to participants and evaluators. It was not known which etching method and application mode was applied to which teeth of the participants.

Arm	Type	Receives
Group I	Other	Procedure: Total-etch mode with 35% phosphoric acid (K-ETCHANT) (TE-A group)Total-etch mode with 35% phosphoric acid
Group II	Other	Procedure: Selective-etch mode with 35% phosphoric acid (K-ETCHANT) (SE-A group)Selective-etch mode with 35% phosphoric acid
Group III	Other	Procedure: Total-etch mode with Er, Cr: YSGG laser (Waterlase MD) (TE-L group)Total-etch mode with laser (Er,Cr:YSGG)
Group IV	Other	Procedure: Selective-etch mode with Er, Cr: YSGG laser (Waterlase MD) (SE-L group).Selective-etch mode with laser (Er,Cr:YSGG)
Group V	Other	Procedure: Self-etch mode Clearfil Universal Bond Quick (Kuraray, Japan) (SE group)Self-etch mode

Who may qualify

Ages: 18 to 75 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

Participants were 18 years of age or older,
no possible health problems (such as allergies) related to resin-based restorations,
good general health,
having at least five non-carious cervical lesions.
The depth of the lesions were at least 1 mm, without carious, not previously restored, having teeth with vital, enamel and dentin tissue.

Key exclusion criteria (6 listed)

Participant had fewer than 20 teeth,
having poor oral hygiene,
uncontrolled periodontal disease,
xerostomia,
pregnancy or breastfeeding possible health problems (such as allergy) related to resin-based restorations,

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
Total-etch mode with 35% phosphoric acid (K-ETCHANT) (TE-A group)35% phosphoric acid was applied to enamel and dentin for 10 s, washed and dried for 5 s. The universal adhesive, Clearfil Universal Bond Quick (CBQ) was applied to enamel and dentin surfaces with a single-use applicator, then gently air-dried for 5 s without waiting, and light-cured for 10 s.	Procedure or surgery	Group I
Selective-etch mode with 35% phosphoric acid (K-ETCHANT) (SE-A group)35% phosphoric acid was used only on enamel for 10 s, then washed and dried for 5 seconds. Subsequently, the adhesive was applied in a similar manner to the TE-A group.	Procedure or surgery	Group II
Total-etch mode with Er, Cr: YSGG laser (Waterlase MD) (TE-L group)the enamel margin and dentin surfaces of lesions were irradiated with an Er,Cr:YSGG laser (2780 nm, Waterlase MD, BioLase Technology, Inc., San Clemente, CA). Then the adhesive was applied in a similar manner to the TE-A group.	Procedure or surgery	Group III
Selective-etch mode with Er, Cr: YSGG laser (Waterlase MD) (SE-L group).The laser system was applied in the same way as described in the TE-L group only on enamel surface. Subsequently, the adhesive was applied in the same way as described in the TE-A group.	Procedure or surgery	Group IV
Self-etch mode Clearfil Universal Bond Quick (Kuraray, Japan) (SE group)Universal adhesive system (CBQ) was applied to enamel and dentin surfaces without any previous etching. Then gently air-dried for 5 s without waiting, and light-cured for 10 s.	Procedure or surgery	Group V

Primary outcome

Retention,
Time frame: From baseline to 2 year the change of restorations was evaluated
The retention criterion determines how long a restorative material functions in the oral environment, it is the most important criterion that shows the success of the material. Alpha: The restoration is present. Charlie: The restoration is absent.
Marginal Discoloration
Time frame: From baseline to 2 year the change of restorations was evaluated
The marginal discoloration that occur at the edge staining restoration boundaries are generally thought to be due to microleakage. Alpha: No discoloration at margins. Bravo: Shallow discoloration, clinically acceptable. Charlie: Deep discoloration clinically unacceptable.
Marginal Adaptation
Time frame: From baseline to 2 year the change of restorations was evaluated
Marginal adaptation is achieved by fully ensuring the integrity of the tooth-restoration joint border. Alpha: Restoration is closely adapted to the tooth. 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: From baseline to 2 year the change of restorations was evaluated
Color match is the evaluation of the restoration according to the darkening or lightening of the color, taking into account the tooth tissue surrounding restoration. Alpha:Matches tooth. Bravo: Acceptable mismatch. Charlie:Unacceptable mismatch.
Post-op Hypersensitivity
Time frame: From baseline to 2 year the change of restorations was evaluated
Determination of sensitivity after restorations are placed. Alpha: Absent. Charlie: Present; clinically unacceptable.
Secondary Caries
Time frame: From baseline to 2 year the change of restorations was evaluated
Secondary caries is the progression of caries in the tooth tissue adjacent to the restorations. Caries formation means restoration failure. Alpha: Absent. Charlie: Present; clinically unacceptable.

Results and safety

Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 26 Mar 2021.
Background: PubMed 32852126Atalay C, Uslu A, Yazici AR. Does laser etching have an effect on application mode of a universal adhesive?-A microleakage and scanning electron microscopy evaluation. Microsc Res Tech. 2021 Jan;84(1):125-132. doi: 10.1002/jemt.23573. Epub 2020 Aug 27.
Background: PubMed 31468262Atalay C, Ozgunaltay G, Yazici AR. Thirty-six-month clinical evaluation of different adhesive strategies of a universal adhesive. Clin Oral Investig. 2020 Apr;24(4):1569-1578. doi: 10.1007/s00784-019-03052-2. Epub 2019 Aug 30.
Related InfoLink provided by the sponsor.

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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

Hacettepe University

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 5 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 26 Mar 2021. 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?

Results are not available in the source record.

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: From baseline to 2 year the change of restorations was evaluated). 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 NCT04814836, which also lists 2 linked publications.

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 Mar 2021; AzTrials last refreshed its copy on 29 Oct 2026.