Non-carious Cervical LesionsNCT04707898
Clinical Evaluation of Different Universal Adhesive Systems in Non-carious Cervical Lesions.
A study testing Single Bond Universal and G-Premio Bond in people with Non-carious Cervical Lesions, run by Okan University at 1 site in Turkey (Türkiye).
Trial summary
The aim of the study is to compare the performance of universal adhesives containing different-solvent-based in the restoration of non-carious cervical lesions (NCCLs). Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Non-carious Cervical Lesions
- What is being tested?
- Single Bond Universal and G-Premio Bond
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Oct 2020to 15 Nov 2022
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Participant age should be 18-65 years.
- Good general health condition
- Good oral hygiene
- Should have at least 4 noncarious cervical lesion
- Must not have rampant caries
- At least 20 teeth in occlusion
Who cannot join
- Serious medical problems, allergies to product ingredients
- Poor oral hygiene
- Severe periodontal problems
- Caries or restorative treatment on teeth included in the study
- Parafunctional behavior
- Abutment of tested teeth to a removable prosthesis.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Istanbul Okan University Faculty of Dentistry
Istanbul, Tuzla, 34959
About this study
Official title: Clinical Evaluation of Different Solvent-based Universal Adhesive Systems in Non-carious Cervical Lesions.
The aim of the study is to compare the performance of universal adhesives containing different-solvent-based in the restoration of non-carious cervical lesions (NCCLs).
Read the detailed description
The study was approved by the Ethics Committee of the Istanbul University Faculty of Dentistry in accordance with protocol no. 2019/37-Rev/2. All participants will be informed about the study and will sign the written informed consent prior to the first treatment.
The tested materials are the universal adhesive systems: Single Bond Universal (3M ESPE, St. Paul, MN, USA) and G-Premio Bond (GC Corporation, Tokyo, Japan). Both adhesive systems will be used in selective-etch approach. All restorations will replaced by a single experienced dentist. In this study PASS 11 Software was used to calculate the sample size. At least 230 restorations (n=115) will be included for this study.
The patients will be given local anesthesia if required to prevent discomfort during the intervention. Prior to the restorative procedure the teeth will be cleaned with a pumice water slurry, using a rubber cup. The walls of the lesions are gently and superficially roughened using a round coarse diamond bur before adhesive procedures. Isolation of the tooth will be achieved by the use of cotton rolls and a saliva aspirator, a retraction cord (Ultrapak, Ultradent Products, Inc., South Jordan, USA). Both adhesives will be applied in manufacturer' s instructions with random order, by which the first randomly selected adhesive will be used to restore the tooth with the lowest tooth number (according to the FDI system), and the alternative adhesive will be used for the tooth with the second lowest tooth number. This method will be used for every other tooth requiring a cervical restoration. After adhesive procedures, resin composite will be placed and each increment light cured for 20 seconds (Elipar S10, 3M ESPE, St.Paul, MN, USA). The restorations are then finished and polished.
Restorations will be assessed 7 days after placement (baseline) and after 6, 12, 18, and 24months. Clinical examination will be performed by two blinded examiners, who were not involved in the treatments. Each restoration will be evaluated clinically using a dental loupe according to FDI World Dental Federation criteria. Three main groups- esthetic, functional, biological properties- and their sub-categorizes of FDI World Dental Federation criteria will be scored on a scale of 1 to 5.
Esthetic properties: Surface lustre, surface staining, marginal staining, color match and translucency, esthetical anatomical form
Functional properties: Fracture of material and retention, marginal adaptation, wear, approximal anatomical form, patient's view.
Biological properties: Post-operative sensitivity, recurrence of caries, erosion, abfraction, tooth integrity, periodontal response, adjacent mucosa, oral and general health.
Statistical analysis will be performed using IBM SPSS V23 Software. The data is analyzed with Chi- Square, Friedman Test, Bonferroni Test adjustment, Wilcoxon Tests (p < 0.05).
- Conditions
- Non-carious Cervical Lesions
- Being tested
- Single Bond Universal, G-Premio Bond
- Keywords
- universal adhesive, non-carious lesions, randomized clinical trial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Single Bond UniversalDevice
Adhesive system
G-Premio BondDevice
Adhesive system
| Study group | Role | What they receive |
|---|---|---|
| Group Single Bond Universal | Experimental | Single Bond Universal adhesive system with selective-etch approach following the manufacturer's instruction Receives: Device: Single Bond Universal |
| Group G-Premio Bond | Experimental | G-Premio Bond Adhesive System with selective-etch approach following the manufacturer's instruction Receives: Device: G-Premio Bond |
What is being measured
The primary outcome is the main question the study is designed to answer.
FDI World Dental Federation criteria
Retention and marginal adaptation
Measured: 24-months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2021
- Study start15 Oct 2020
- Primary completion15 Oct 2022 (estimated)
- Study completion15 Nov 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Non-carious Cervical LesionsStudies 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
- A randomized controlled clinical trial
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 32 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Okan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gulsah YENIER, Okan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04707898
- Sponsor's protocol ID
- 2019/37-Rev/2
- Status last verified
- Jan 2021
- First submitted
- 10 Jan 2021
- Last updated
- 13 Jan 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Van Landuyt KL, Peumans M, Fieuws S, De Munck J, Cardoso MV, Ermis RB, Lambrechts P, Van Meerbeek B. A randomized controlled clinical trial of a HEMA-free all-in-one adhesive in non-carious cervical lesions at 1 year. J Dent. 2008 Oct;36(10):847-55. doi: 10.1016/j.jdent.2008.06.005. Epub 2008 Jul 25.
PubMed 18656295Ermis RB, Van Landuyt KL, Cardoso MV, De Munck J, Van Meerbeek B, Peumans M. Clinical effectiveness of a one-step self-etch adhesive in non-carious cervical lesions at 2 years. Clin Oral Investig. 2012 Jun;16(3):889-97. doi: 10.1007/s00784-011-0565-4. Epub 2011 May 21.
PubMed 21603966Moretto SG, Russo EM, Carvalho RC, De Munck J, Van Landuyt K, Peumans M, Van Meerbeek B, Cardoso MV. 3-year clinical effectiveness of one-step adhesives in non-carious cervical lesions. J Dent. 2013 Aug;41(8):675-82. doi: 10.1016/j.jdent.2013.05.016. Epub 2013 Jun 6.
PubMed 23747824Lawson NC, Robles A, Fu CC, Lin CP, Sawlani K, Burgess JO. Two-year clinical trial of a universal adhesive in total-etch and self-etch mode in non-carious cervical lesions. J Dent. 2015 Oct;43(10):1229-34. doi: 10.1016/j.jdent.2015.07.009. Epub 2015 Jul 29.
PubMed 26231300Hafer M, Jentsch H, Haak R, Schneider H. A three-year clinical evaluation of a one-step self-etch and a two-step etch-and-rinse adhesive in non-carious cervical lesions. J Dent. 2015 Mar;43(3):350-61. doi: 10.1016/j.jdent.2014.12.009. Epub 2014 Dec 23.
PubMed 25541248Szesz A, Parreiras S, Reis A, Loguercio A. Selective enamel etching in cervical lesions for self-etch adhesives: A systematic review and meta-analysis. J Dent. 2016 Oct;53:1-11. doi: 10.1016/j.jdent.2016.05.009. Epub 2016 Jul 2.
PubMed 27381814Yurdaguven GY, Dogruer I, Cam M, Ulukapi H, Aykor AA. Clinical evaluation of different solvent type and HEMA-content of universal adhesive systems in non-carious cervical lesions: a two-year double-blind split-mouth randomized clinical trial. BMC Oral Health. 2025 Oct 22;25(1):1661. doi: 10.1186/s12903-025-07081-0.
PubMed 41126209
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Evaluation of Different Solvent-based Universal Adhesive Systems in Non-carious Cervical Lesions.
- ClinicalTrials.gov ID
- NCT04707898
- Acronym / sponsor ID
- 2019/37-Rev/2
- Conditions
- Non-carious Cervical Lesions
- Keywords
- universal adhesive, non-carious lesions, randomized clinical trial
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 32 participants (estimated)
- Lead sponsor
- Okan UniversityUniversity, hospital or other
- Study start
- 15 Oct 2020 (actual)
- Primary completion
- 15 Oct 2022 (estimated)
- Study completion
- 15 Nov 2022 (estimated)
- First posted
- 13 Jan 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 is to compare the performance of universal adhesives containing different-solvent-based in the restoration of non-carious cervical lesions (NCCLs).
Detailed description
The study was approved by the Ethics Committee of the Istanbul University Faculty of Dentistry in accordance with protocol no. 2019/37-Rev/2. All participants will be informed about the study and will sign the written informed consent prior to the first treatment.
The tested materials are the universal adhesive systems: Single Bond Universal (3M ESPE, St. Paul, MN, USA) and G-Premio Bond (GC Corporation, Tokyo, Japan). Both adhesive systems will be used in selective-etch approach. All restorations will replaced by a single experienced dentist. In this study PASS 11 Software was used to calculate the sample size. At least 230 restorations (n=115) will be included for this study.
The patients will be given local anesthesia if required to prevent discomfort during the intervention. Prior to the restorative procedure the teeth will be cleaned with a pumice water slurry, using a rubber cup. The walls of the lesions are gently and superficially roughened using a round coarse diamond bur before adhesive procedures. Isolation of the tooth will be achieved by the use of cotton rolls and a saliva aspirator, a retraction cord (Ultrapak, Ultradent Products, Inc., South Jordan, USA). Both adhesives will be applied in manufacturer' s instructions with random order, by which the first randomly selected adhesive will be used to restore the tooth with the lowest tooth number (according to the FDI system), and the alternative adhesive will be used for the tooth with the second lowest tooth number. This method will be used for every other tooth requiring a cervical restoration. After adhesive procedures, resin composite will be placed and each increment light cured for 20 seconds (Elipar S10, 3M ESPE, St.Paul, MN, USA). The restorations are then finished and polished.
Restorations will be assessed 7 days after placement (baseline) and after 6, 12, 18, and 24months. Clinical examination will be performed by two blinded examiners, who were not involved in the treatments. Each restoration will be evaluated clinically using a dental loupe according to FDI World Dental Federation criteria. Three main groups- esthetic, functional, biological properties- and their sub-categorizes of FDI World Dental Federation criteria will be scored on a scale of 1 to 5.
Esthetic properties: Surface lustre, surface staining, marginal staining, color match and translucency, esthetical anatomical form
Functional properties: Fracture of material and retention, marginal adaptation, wear, approximal anatomical form, patient's view.
Biological properties: Post-operative sensitivity, recurrence of caries, erosion, abfraction, tooth integrity, periodontal response, adjacent mucosa, oral and general health.
Statistical analysis will be performed using IBM SPSS V23 Software. The data is analyzed with Chi- Square, Friedman Test, Bonferroni Test adjustment, Wilcoxon Tests (p < 0.05).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- A randomized controlled clinical trial
| Arm | Type | Receives |
|---|---|---|
| Group Single Bond Universal | Experimental | Device: Single Bond UniversalSingle Bond Universal adhesive system with selective-etch approach following the manufacturer's instruction |
| Group G-Premio Bond | Experimental | Device: G-Premio BondG-Premio Bond Adhesive System with selective-etch approach following the manufacturer's instruction |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Participant age should be 18-65 years.
- Good general health condition
- Good oral hygiene
- Should have at least 4 noncarious cervical lesion
- Must not have rampant caries
Key exclusion criteria (6 listed)
- Serious medical problems, allergies to product ingredients
- Poor oral hygiene
- Severe periodontal problems
- Caries or restorative treatment on teeth included in the study
- Parafunctional behavior
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 |
|---|---|---|
| Single Bond UniversalAdhesive system | Device | Group Single Bond Universal |
| G-Premio BondAdhesive system | Device | Group G-Premio Bond |
Primary outcome
FDI World Dental Federation criteria
Time frame: 24-months
Retention and marginal adaptation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2021.
- Background: PubMed 18656295Van Landuyt KL, Peumans M, Fieuws S, De Munck J, Cardoso MV, Ermis RB, Lambrechts P, Van Meerbeek B. A randomized controlled clinical trial of a HEMA-free all-in-one adhesive in non-carious cervical lesions at 1 year. J Dent. 2008 Oct;36(10):847-55. doi: 10.1016/j.jdent.2008.06.005. Epub 2008 Jul 25.
- Background: PubMed 21603966Ermis RB, Van Landuyt KL, Cardoso MV, De Munck J, Van Meerbeek B, Peumans M. Clinical effectiveness of a one-step self-etch adhesive in non-carious cervical lesions at 2 years. Clin Oral Investig. 2012 Jun;16(3):889-97. doi: 10.1007/s00784-011-0565-4. Epub 2011 May 21.
- Background: PubMed 23747824Moretto SG, Russo EM, Carvalho RC, De Munck J, Van Landuyt K, Peumans M, Van Meerbeek B, Cardoso MV. 3-year clinical effectiveness of one-step adhesives in non-carious cervical lesions. J Dent. 2013 Aug;41(8):675-82. doi: 10.1016/j.jdent.2013.05.016. Epub 2013 Jun 6.
- Background: PubMed 26231300Lawson NC, Robles A, Fu CC, Lin CP, Sawlani K, Burgess JO. Two-year clinical trial of a universal adhesive in total-etch and self-etch mode in non-carious cervical lesions. J Dent. 2015 Oct;43(10):1229-34. doi: 10.1016/j.jdent.2015.07.009. Epub 2015 Jul 29.
- Background: PubMed 25541248Hafer M, Jentsch H, Haak R, Schneider H. A three-year clinical evaluation of a one-step self-etch and a two-step etch-and-rinse adhesive in non-carious cervical lesions. J Dent. 2015 Mar;43(3):350-61. doi: 10.1016/j.jdent.2014.12.009. Epub 2014 Dec 23.
- Background: PubMed 27381814Szesz A, Parreiras S, Reis A, Loguercio A. Selective enamel etching in cervical lesions for self-etch adhesives: A systematic review and meta-analysis. J Dent. 2016 Oct;53:1-11. doi: 10.1016/j.jdent.2016.05.009. Epub 2016 Jul 2.
- Derived from this study: PubMed 41126209Yurdaguven GY, Dogruer I, Cam M, Ulukapi H, Aykor AA. Clinical evaluation of different solvent type and HEMA-content of universal adhesive systems in non-carious cervical lesions: a two-year double-blind split-mouth randomized clinical trial. BMC Oral Health. 2025 Oct 22;25(1):1661. doi: 10.1186/s12903-025-07081-0.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Single Bond Universal and G-Premio Bond in people with Non-carious Cervical Lesions, run by Okan 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 6 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 13 Jan 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?
FDI World Dental Federation criteria (time frame: 24-months). 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 NCT04707898, which also lists 7 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 13 Jan 2021.