Non Carious Cervical LesionNCT05635981
Effect of an Additional Hydrophobic Adhesive Layer Application on the Class V Composite Restorations
A study testing Clearfil Majesty ES-2 Resin Composit Application to Non-carious Cervical Lesions in people with Non Carious Cervical Lesion, run by Istanbul University at 1 site in Turkey (Türkiye).
Trial summary
In restorative dentistry, to enhance bond strength between dentin and simplified adhesive systems, new materials or applications are constantly being developed all the time. In order to create a better hybrid layer quality, modifications are made to the chemical contents and application methods of the adhesives. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Non Carious Cervical Lesion
- What is being tested?
- Clearfil Majesty ES-2 Resin Composit Application to Non-carious Cervical Lesions
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 20 Jan 2019to 1 Apr 2021
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 18 and over 18 years old
- Having acceptable oral hygiene
- Good general health
- Having at least 20 teeth in occlusion
- Presence of at least 4 non-carious cervical lesions in the mouth that require treatment
- Lesions without caries
Show all 9Show fewer
- Patient's consent to come to control appointments
- Vital and non-mobility of the tooth with the lesion
- During occlusion, the tooth with the lesion is in contact with the antagonist tooth.
Who cannot join
- Under 18 years old
- Having poor oral hygiene
- Poor general health condition
- Pregnancy or breastfeeding status
- Orthodontic application in the last 3 months
- The tooth with the lesion has pulpitis, mobility or it is non-vital
Show all 9Show fewer
- Presence of advanced bruxism
- The tooth with the lesion is a prosthetic abutment
- Presence of advanced periodontitis or periodontal surgery in the last 3 months
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of an Additional Hydrophobic Adhesive Layer Application on the Clinical Performance of Class V Composite Restorations: an 18-month Randomized Clinical Trial
In restorative dentistry, to enhance bond strength between dentin and simplified adhesive systems, new materials or applications are constantly being developed all the time. In order to create a better hybrid layer quality, modifications are made to the chemical contents and application methods of the adhesives. For inhibition or slow down of collagen or resin matrix degradation at the adhesive interface, procedures like using protease enzyme inhibitors or additional hydrophobic layer applications are tested by in vitro and in vivo studies.
The main goal of this double-blind randomized clinical trial is to evaluate the 18-month clinical performances of two different one-step dentin adhesives that were applied alone or with an additional hydrophobic adhesive layer to non-carious cervical lesions.
The hypotheses are that (1) Additional Hydrophobic Adhesive layer application can provide better clinical performance in class V restorations and, (2) the HEMA content will cause statistically different clinical performances.
Read the detailed description
In this study, Clearfil S3 Bond Plus (one-step self-etch adhesive), G-Premio Bond (Universal adhesive), Heliobond (additional hydrophobic adhesive), and Clearfil Majesty ES-2 (nano-hybrid composite) materials will be used. After performing selective etching with Scotchbond Universal Etchant, four different adhesive procedures will be applied according to manufacturers' instructions to the non-carious cervical lesions selected by the randomized method. In the first group Clearfil S3 Bond Plus, in the second group Clearfil S3 Bond Plus and additional hydrophobic adhesive layer (Heliobond), in the third group G-Premio Bond, in the fourth group, G-Premio Bond and additional hydrophobic adhesive layer (Heliobond) will be applied to the NCCL lesions. Restorations will be accomplished by using Clearfil Majesty ES-2 composite material. Restorations will be evaluated according to FDI criteria. Esthetic properties will be evaluated with surface luster, marginal staining, color match and translucency, esthetic anatomical form parameters. Functional properties will be evaluated with fracture and retention, and marginal adaptation parameters. Biological properties will be evaluated with post-operative sensitivity, periodontal response, and secondary caries parameters. Scores 1, 2, and 3 represent clinically acceptable restorations, and scores 4 and 5 represent clinically unacceptable restorations.
- Conditions
- Non Carious Cervical Lesion
- Being tested
- Clearfil Majesty ES-2 Resin Composit Application to Non-carious Cervical Lesions
- Keywords
- Non Carious Cervical Lesion, Additional Adhesive Layer Application, FDI Criteria, Class V Restorations, Split-Mouth Clinical Study
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Clearfil Majesty ES-2 Resin Composit Application to Non-carious Cervical LesionsOther
A restorative treatment method that is applied to non-carious cervical lesions using composite resin restoration after adhesive material application.
| Study group | Role | What they receive |
|---|---|---|
| Clearfil S3 Bond Plus | Active comparator | After selective etching is applied to the enamel surface, Clearfil S3 Bond Plus is applied according to the manufacturer's instructions, restorations are completed with Clearfil Majesty ES-2.
Clearfil S3 Bond Plus: one-step self-etch adhesive with HEMA Receives: Other: Clearfil Majesty ES-2 Resin Composit Application to Non-carious Cervical Lesions |
| Clearfil S3 Bond Plus with Additional Hydrophobic Adhesive Layer Application | Experimental | After selective etching is applied to the enamel surface, Clearfil S3 Bond Plus is applied according to the manufacturer's instructions. Heliobond is applied as an additional hydrophobic adhesive layer and restorations are completed with Clearfil Majesty ES-2.
Clearfil S3 Bond Plus: one-step self-etch adhesive with HEMA Heliobond: hydrophobic adhesive with Bis-GMA and TEGDMA Receives: Other: Clearfil Majesty ES-2 Resin Composit Application to Non-carious Cervical Lesions |
| G-Premio Bond | Active comparator | After selective etching is applied to the enamel surface, G-Premio Bond is applied according to the manufacturer's instructions, restorations are completed with Clearfil Majesty ES-2.
G-Premio Bond: universal adhesive without HEMA Receives: Other: Clearfil Majesty ES-2 Resin Composit Application to Non-carious Cervical Lesions |
| G-Premio Bond with Additional Hydrophobic Adhesive Layer Application | Experimental | After selective etching is applied to the enamel surface, G-Premio Bond is applied according to the manufacturer's instructions. Heliobond is applied as an additional hydrophobic adhesive layer and restorations are completed with Clearfil Majesty ES-2.
G-Premio Bond: universal adhesive without HEMA Heliobond: hydrophobic adhesive with Bis-GMA and TEGDMA Receives: Other: Clearfil Majesty ES-2 Resin Composit Application to Non-carious Cervical Lesions |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fracture and Retention
While scoring the fracture and retention parameters, restoration; If there is no fracture with a score of 1 if there are linear cracks with a score of 2 if there are large cracks and fractures that do not affect the marginal integrity and contact with a score of 3 if there are small fractures affecting the marginal integrity or contact or if there are fractures less than half the size of the restoration a score of 4 is a large part of the restoration or In case of losing all, it is evaluated with a score of 5.
Measured: 18 month
Surface Luster
Restoration; A score of 1 if the surface's glossiness is at the same level as enamel, a score of 2 if there are opacity and pores that cannot be noticed from the speaking distance, an acceptable opacity when covered with saliva, or a score of 3 if more than 1/3 of the surface has pores, and a score of 4 if there is a roughness that cannot be masked with saliva and cannot be removed by polishing. If there is a roughness that causes plaque retention, it is evaluated with a score of 5.
Measured: 18 month
Marginal Staining
It is scored as 1 if there is no discoloration on the marginal edges, 2 if there is discoloration that can be easily removed by polishing, 3 if there is moderate discoloration that cannot be accepted aesthetically, 4 if there is noticeable large discoloration that requires repair, and 5 if there is deep marginal discoloration that cannot be repaired.
Measured: 18 month
Marginal Adaptation
If there is no gap at the marginal margins and the tooth tissue is compatible 1, if there is a small gap, line, fracture or step that can be removed by polishing, 2 if there are indentations, if there is a small gap that cannot be removed by polishing, if there is more than one marginal fracture or large indentations 3, if the dentin is exposed repair It is scored 4 if there are large openings, fractures, or indentations that require it, and 5 if there are large openings and irregularities where part of the restoration is lost.
Measured: 18 month
Color Match and Translucency
While scoring the color match and translucency, the restoration and the tissue color are compatible with each other and there is no difference in translucency 1, if there are minor changes in color or translucency 2, if there is a clear but acceptable color difference (more opaque-translucent-light-dark) 3, at a level that can be corrected with repair and 4 if there is a significant color difference, and 5 if there is an unacceptable color difference.
Measured: 18 month
Esthetic Anatomical Form
While scoring the aesthetic anatomical form, the form of the restoration is scored 1 if it is ideal, 2 if it is not ideal but will be ideal with a small intervention, 3 if it is not ideal but aesthetically acceptable, 4 if it is not aesthetically acceptable and repair is required, and 5 if it is unacceptable and needs to be changed.
Measured: 18 month
Periodontal Response
During periodontal response scoring, if there is no plaque accumulation, pocket formation or inflammation in the restored tooth, 1, if there is a small amount of plaque accumulation and no inflammation and pocket formation, 2, if the papillary bleeding index increases by 1 point compared to the baseline, 3 if the papillary bleeding index increases by more than 1 point and periodontal bleeding index increases by more than 1 point It is scored 4 if there is an increase in the pocket more than 1 mm, and 5 if there is acute gingivitis or acute periodontitis.
Measured: 18 month
Post Operative Sensitivity
Restoration; It is evaluated with a score of 1 if there is no sensitivity complaint, with a score of 2 if there is a small amount of sensitivity for a short time, and a score of 3 if the patient has no complaints and moderate sensitivity, with a score of 3 if there is hypersensitivity that does not require restoration replacement but requires repair, and a score of 4 if endodontic treatment is required.
Measured: 18 month
Secondary Caries
Restoration; It is evaluated with a score of 1 if there is no caries formation, with a score of 2 if there is small and localized demineralization, and a score of 3 if there is demineralization in a large area that requires only precautions, and a score of 4 if there is cavitation that requires repair, and a score of 5 if there is a deep caries that cannot be repaired.
Measured: 18 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2022
- Study start20 Jan 2019
- Primary completion10 Mar 2021
- Study completion1 Apr 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non Carious Cervical LesionStudies of the same condition, open and under way.
- More trials run by Istanbul 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
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Meric Berkman, Istanbul University
- Investigators
- Meriç Berkman, pHD, Principal investigator, Istanbul UniversitySafa Tuncer, Professor, Study chair, Istanbul University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05635981
- Sponsor's protocol ID
- 2018/76
- Status last verified
- Nov 2022
- First submitted
- 28 Oct 2022
- Last updated
- 2 Dec 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of an Additional Hydrophobic Adhesive Layer Application on the Clinical Performance of Class V Composite Restorations: an 18-month Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT05635981
- Acronym / sponsor ID
- 2018/76
- Conditions
- Non Carious Cervical Lesion
- Keywords
- Non Carious Cervical Lesion, Additional Adhesive Layer Application, FDI Criteria, Class V Restorations, Split-Mouth Clinical Study
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- Istanbul UniversityUniversity, hospital or other
- Study start
- 20 Jan 2019 (actual)
- Primary completion
- 10 Mar 2021 (actual)
- Study completion
- 1 Apr 2021 (actual)
- First posted
- 2 Dec 2022 (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.
In restorative dentistry, to enhance bond strength between dentin and simplified adhesive systems, new materials or applications are constantly being developed all the time. In order to create a better hybrid layer quality, modifications are made to the chemical contents and application methods of the adhesives. For inhibition or slow down of collagen or resin matrix degradation at the adhesive interface, procedures like using protease enzyme inhibitors or additional hydrophobic layer applications are tested by in vitro and in vivo studies.
The main goal of this double-blind randomized clinical trial is to evaluate the 18-month clinical performances of two different one-step dentin adhesives that were applied alone or with an additional hydrophobic adhesive layer to non-carious cervical lesions.
The hypotheses are that (1) Additional Hydrophobic Adhesive layer application can provide better clinical performance in class V restorations and, (2) the HEMA content will cause statistically different clinical performances.
Detailed description
In this study, Clearfil S3 Bond Plus (one-step self-etch adhesive), G-Premio Bond (Universal adhesive), Heliobond (additional hydrophobic adhesive), and Clearfil Majesty ES-2 (nano-hybrid composite) materials will be used. After performing selective etching with Scotchbond Universal Etchant, four different adhesive procedures will be applied according to manufacturers' instructions to the non-carious cervical lesions selected by the randomized method. In the first group Clearfil S3 Bond Plus, in the second group Clearfil S3 Bond Plus and additional hydrophobic adhesive layer (Heliobond), in the third group G-Premio Bond, in the fourth group, G-Premio Bond and additional hydrophobic adhesive layer (Heliobond) will be applied to the NCCL lesions. Restorations will be accomplished by using Clearfil Majesty ES-2 composite material. Restorations will be evaluated according to FDI criteria. Esthetic properties will be evaluated with surface luster, marginal staining, color match and translucency, esthetic anatomical form parameters. Functional properties will be evaluated with fracture and retention, and marginal adaptation parameters. Biological properties will be evaluated with post-operative sensitivity, periodontal response, and secondary caries parameters. Scores 1, 2, and 3 represent clinically acceptable restorations, and scores 4 and 5 represent clinically unacceptable restorations.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Clearfil S3 Bond Plus | Active comparator | Other: Clearfil Majesty ES-2 Resin Composit Application to Non-carious Cervical LesionsAfter selective etching is applied to the enamel surface, Clearfil S3 Bond Plus is applied according to the manufacturer's instructions, restorations are completed with Clearfil Majesty ES-2. Clearfil S3 Bond Plus: one-step self-etch adhesive with HEMA |
| Clearfil S3 Bond Plus with Additional Hydrophobic Adhesive Layer Application | Experimental | Other: Clearfil Majesty ES-2 Resin Composit Application to Non-carious Cervical LesionsAfter selective etching is applied to the enamel surface, Clearfil S3 Bond Plus is applied according to the manufacturer's instructions. Heliobond is applied as an additional hydrophobic adhesive layer and restorations are completed with Clearfil Majesty ES-2. Clearfil S3 Bond Plus: one-step self-etch adhesive with HEMA Heliobond: hydrophobic adhesive with Bis-GMA and TEGDMA |
| G-Premio Bond | Active comparator | Other: Clearfil Majesty ES-2 Resin Composit Application to Non-carious Cervical LesionsAfter selective etching is applied to the enamel surface, G-Premio Bond is applied according to the manufacturer's instructions, restorations are completed with Clearfil Majesty ES-2. G-Premio Bond: universal adhesive without HEMA |
| G-Premio Bond with Additional Hydrophobic Adhesive Layer Application | Experimental | Other: Clearfil Majesty ES-2 Resin Composit Application to Non-carious Cervical LesionsAfter selective etching is applied to the enamel surface, G-Premio Bond is applied according to the manufacturer's instructions. Heliobond is applied as an additional hydrophobic adhesive layer and restorations are completed with Clearfil Majesty ES-2. G-Premio Bond: universal adhesive without HEMA Heliobond: hydrophobic adhesive with Bis-GMA and TEGDMA |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 18 and over 18 years old
- Having acceptable oral hygiene
- Good general health
- Having at least 20 teeth in occlusion
- Presence of at least 4 non-carious cervical lesions in the mouth that require treatment
Key exclusion criteria (9 listed)
- Under 18 years old
- Having poor oral hygiene
- Poor general health condition
- Pregnancy or breastfeeding status
- Orthodontic application in the last 3 months
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 |
|---|---|---|
| Clearfil Majesty ES-2 Resin Composit Application to Non-carious Cervical LesionsA restorative treatment method that is applied to non-carious cervical lesions using composite resin restoration after adhesive material application. | Other | Clearfil S3 Bond Plus, Clearfil S3 Bond Plus with Additional Hydrophobic Adhesive Layer Application, G-Premio Bond, G-Premio Bond with Additional Hydrophobic Adhesive Layer Application |
Primary outcome
Fracture and Retention
Time frame: 18 month
While scoring the fracture and retention parameters, restoration; If there is no fracture with a score of 1 if there are linear cracks with a score of 2 if there are large cracks and fractures that do not affect the marginal integrity and contact with a score of 3 if there are small fractures affecting the marginal integrity or contact or if there are fractures less than half the size of the restoration a score of 4 is a large part of the restoration or In case of losing all, it is evaluated with a score of 5.
Surface Luster
Time frame: 18 month
Restoration; A score of 1 if the surface's glossiness is at the same level as enamel, a score of 2 if there are opacity and pores that cannot be noticed from the speaking distance, an acceptable opacity when covered with saliva, or a score of 3 if more than 1/3 of the surface has pores, and a score of 4 if there is a roughness that cannot be masked with saliva and cannot be removed by polishing. If there is a roughness that causes plaque retention, it is evaluated with a score of 5.
Marginal Staining
Time frame: 18 month
It is scored as 1 if there is no discoloration on the marginal edges, 2 if there is discoloration that can be easily removed by polishing, 3 if there is moderate discoloration that cannot be accepted aesthetically, 4 if there is noticeable large discoloration that requires repair, and 5 if there is deep marginal discoloration that cannot be repaired.
Marginal Adaptation
Time frame: 18 month
If there is no gap at the marginal margins and the tooth tissue is compatible 1, if there is a small gap, line, fracture or step that can be removed by polishing, 2 if there are indentations, if there is a small gap that cannot be removed by polishing, if there is more than one marginal fracture or large indentations 3, if the dentin is exposed repair It is scored 4 if there are large openings, fractures, or indentations that require it, and 5 if there are large openings and irregularities where part of the restoration is lost.
Color Match and Translucency
Time frame: 18 month
While scoring the color match and translucency, the restoration and the tissue color are compatible with each other and there is no difference in translucency 1, if there are minor changes in color or translucency 2, if there is a clear but acceptable color difference (more opaque-translucent-light-dark) 3, at a level that can be corrected with repair and 4 if there is a significant color difference, and 5 if there is an unacceptable color difference.
Esthetic Anatomical Form
Time frame: 18 month
While scoring the aesthetic anatomical form, the form of the restoration is scored 1 if it is ideal, 2 if it is not ideal but will be ideal with a small intervention, 3 if it is not ideal but aesthetically acceptable, 4 if it is not aesthetically acceptable and repair is required, and 5 if it is unacceptable and needs to be changed.
Periodontal Response
Time frame: 18 month
During periodontal response scoring, if there is no plaque accumulation, pocket formation or inflammation in the restored tooth, 1, if there is a small amount of plaque accumulation and no inflammation and pocket formation, 2, if the papillary bleeding index increases by 1 point compared to the baseline, 3 if the papillary bleeding index increases by more than 1 point and periodontal bleeding index increases by more than 1 point It is scored 4 if there is an increase in the pocket more than 1 mm, and 5 if there is acute gingivitis or acute periodontitis.
Post Operative Sensitivity
Time frame: 18 month
Restoration; It is evaluated with a score of 1 if there is no sensitivity complaint, with a score of 2 if there is a small amount of sensitivity for a short time, and a score of 3 if the patient has no complaints and moderate sensitivity, with a score of 3 if there is hypersensitivity that does not require restoration replacement but requires repair, and a score of 4 if endodontic treatment is required.
Secondary Caries
Time frame: 18 month
Restoration; It is evaluated with a score of 1 if there is no caries formation, with a score of 2 if there is small and localized demineralization, and a score of 3 if there is demineralization in a large area that requires only precautions, and a score of 4 if there is cavitation that requires repair, and a score of 5 if there is a deep caries that cannot be repaired.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2022.
- Individual participant dataSharing planned: Yes
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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.
Meriç Berkman, pHD principal investigator
Istanbul University
Safa Tuncer, Professor study chair
Istanbul University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Clearfil Majesty ES-2 Resin Composit Application to Non-carious Cervical Lesions in people with Non Carious Cervical Lesion, run by Istanbul 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 9 inclusion and 9 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: finished, as of the sponsor's last update on 2 Dec 2022. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Fracture and Retention (time frame: 18 month). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 2 Dec 2022.