Non-carious Cervical LesionsPhase 2NCT04565938
Clinical Performance of a One-step Self-etch Adhesive in Non-carious Cervical Lesions at 2 Years
A Phase 2 study testing Application of adhesive for the restoration of dental lesions with resin composite in people with Non-carious Cervical Lesions and Adhesive Performance, run by University of Athens at 1 site in Greece.
Trial summary
Objectives: One-step self-etch adhesives are the latest adhesives introduced into the market. The aim of this randomized controlled clinical trial was to test the hypothesis that a one-step self-etch adhesive performs equally well as a two-step etch-and-rinse adhesive. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Non-carious Cervical Lesions, Adhesive Performance
- What is being tested?
- Application of adhesive for the restoration of dental lesions with resin composite
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteGreece
- Study dates
- 21 Jul 2020to 10 Oct 2020
- Phase
- Phase 2
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- At least three non-carious cervical lesions on incisors, canines and premolars of the upper or lower jaw. Each lesion should be located at the cervical third of the buccal side of the tooth, be either at the same level or above the gums, have its cervical wall on dentin, not extend on adjacent surfaces and not exceed 5mm in length, 3mm in height and 1.5mm in depth
Who cannot join
- Patients receiving periodontal therapy, presenting high caries activity or TMJ problems needing treatment with mouthguards, were excluded from the study.
Trial locations and contacts
1 site in 1 country.
About this study
Objectives: One-step self-etch adhesives are the latest adhesives introduced into the market. The aim of this randomized controlled clinical trial was to test the hypothesis that a one-step self-etch adhesive performs equally well as a two-step etch-and-rinse adhesive.
Materials and methods: Thirty two patients with 96 non-carious cervical lesions received composite-resin restorations (Tetric Evo Ceram - Ivoclar/Vivadent), which were bonded either with a one-step self-etch adhesive (AdheSE One - Ivoclar/Vivadent) with or without enamel etching, or with a two-step etch-and-rinse adhesive (ExiTE - Ivoclar/Vivadent). All restorations were evaluated by two examiners at baseline, 6, 12, 18 and 24 months regarding retention, caries recurrence, marginal integrity and discoloration. Retention loss, severe marginal defects and/or discoloration that needed intervention (repair or replacement) and occurrence of caries, were considered as clinical failures. A logistic regression analysis with generalized estimating equations was used to account for the clustered data (three restorations per patient).
Read the detailed description
Sample selection Patients, receiving dental treatment in the Clinic of Restorative Dentistry, constituted the selection pool. Written informed consent was obtained from all participants before starting treatment. A total of 32 participants were examined to check if they met the inclusion and exclusion criteria by two precalibrated operative dentistry residents. The qualified patients were recruited in the order in which they reported for the screening session, thus forming a convenience sample.
Patients, irrespective of age and gender, should have at least three non-carious cervical lesions on incisors, canines and premolars of the upper or lower jaw. Each lesion should be located at the cervical third of the buccal side of the tooth, be either at the same level or above the gums, have its cervical wall on dentin, not extend on adjacent surfaces and not exceed 5mm in length, 3mm in height and 1.5mm in depth.
Patients receiving periodontal therapy, presenting high caries activity or TMJ problems needing treatment with mouthguards, were excluded from the study.
A total of thirty two patients with ninety six lesions, were eventually included in the study.
Restoration process
All restorations were performed by only one experienced dentist. All three lesions per patient were restored with Tetric EvoCeram (Ivoclar/Vivadent, AG, Shaan, Lichtenstein) (Table X) following one of next adhesive procedures for each tooth, in a statistical random order:
- st method 1. Mechanical removal of sclerotic dentin with a round bur 2. Enamel beveling 3. Enamel (30sec) and dentin (15sec) etching with phosphoric acid 4. Application of ExciTE (Ivoclar/Vivadent, AG, Shaan, Lichtenstein) (Table X) and curing for 10sec with 800mW/cm2 light intensity (Cure TC-01, Spring Health Products, Inc, Norristown, PA, USA) 5. Composite-resin application using a transparent cervical matrix (Kerr-Hawe, Orange, CA, USA) and curing for 40sec 6. Finishing and polishing
- nd method 1. Mechanical removal of sclerotic dentin with a round bur 2. Enamel beveling 3. Application of AdheSE One (Ivoclar/Vivadent, AG, Shaan, Lichtenstein) (Table X) and curing for 10sec 4. Composite-resin application using a transparent cervical matrix and curing for 40sec 5. Finishing and polishing
- rd method 1. Mechanical removal of sclerotic dentin with a round bur 2. Enamel beveling 3. Enamel (30sec) etching with phosphoric acid 4. Application of AdheSE One and curing for 10sec 5. Composite-resin application using a transparent cervical matrix and curing for 40sec 6. Finishing and polishing
Randomization
The methods were applied in random order (using randomization tables), by which the first randomly selected method was used to restore the tooth with the lowest tooth number (according to the FDI system), the second method was used for the tooth with the second lowest tooth number and the third one for the lowest. In case of more than three lesions, an equal number of restorations with each method was ensured. In instances of an uneven number of restorations placed in one patient, the inequality of number of teeth restored with each method was adjusted for by restoring the lesions with the respective methods in the next patient (again according to the respective randomization tables).
Restoration evaluation
Two experienced and calibrated dentists, not involved with the placement of the restorations and therefore blinded to the group assignment, performed the evaluation. For training purposes, the examiners observed 10 photographs that were representative of each score for each criterion. They evaluated 10 to 15 subjects each on 2 consecutive days. These subjects had cervical restorations and they did not participate in this project. An intraexaminer and interexaminer agreement of at least 85% was necessary before the beginning of the evaluation. All restorations were evaluated at baseline, 6, 12, 18 and 24 months according to ….. criteria. The parameters evaluated were retention of the restoration, marginal integrity, marginal discoloration and recurrent caries (Table X).
The parameters were evaluated using the criteria introduced by Hickel et al. 2007, 2010. The overall clinical effectiveness of the tested adhesives was recorded in terms of retention, marginal integrity, marginal discoloration, caries recurrence. Retention loss, occurrence of caries along the restoration margins, severe marginal defects and/or discoloration that needed clinical intervention (repair or replacement) were considered as clinical failure. The clinical effectiveness of the three methods was compared for the abovementioned parameters.
- Conditions
- Non-carious Cervical Lesions, Adhesive Performance
- Being tested
- Application of adhesive for the restoration of dental lesions with resin composite
- Keywords
- One-step Adhesive, Self-etch Adhesive, Non-carious cervical lesions, Clinical trial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Application of adhesive for the restoration of dental lesions with resin compositeProcedure or surgery
- Mechanical removal of sclerotic dentin with a round bur
- Enamel beveling
- Enamel (30sec) and dentin (15sec) etching with phosphoric acid
- Application of ExciTE (Ivoclar/Vivadent, AG, Shaan, Lichtenstein) and curing for 10sec with 800mW/cm2 light intensity (Cure TC-01, Spring Health Products, Inc, Norristown, PA, USA)
- Composite-resin application using a transparent cervical matrix (Kerr-Hawe, Orange, CA, USA) and curing for 40sec
- Finishing and polishing
Application of adhesive for the restoration of dental lesions with resin compositeProcedure or surgery
- Mechanical removal of sclerotic dentin with a round bur
- Enamel beveling
- Application of AdheSE One (Ivoclar/Vivadent, AG, Shaan, Lichtenstein) and curing for 10sec
- Composite-resin application using a transparent cervical matrix and curing for 40sec
- Finishing and polishing
Application of adhesive for the restoration of dental lesions with resin compositeProcedure or surgery
- Mechanical removal of sclerotic dentin with a round bur
- Enamel beveling
- Enamel (30sec) etching with phosphoric acid
- Application of AdheSE One and curing for 10sec
- Composite-resin application using a transparent cervical matrix and curing for 40sec
- Finishing and polishing
| Study group | Role | What they receive |
|---|---|---|
| one-step self-etch adhesive with enamel etching | Experimental | Non carious cervical lesions which will receive composite-resin restorations, with one-step self-etch adhesive with enamel etching Receives: Procedure: Application of adhesive for the restoration of dental lesions with resin composite |
| one-step self-etch adhesive without enamel etching | Experimental | Non carious cervical lesions which will receive composite-resin restorations, with one-step self-etch adhesive without enamel etching Receives: Procedure: Application of adhesive for the restoration of dental lesions with resin composite |
| two-step etch-and-rinse adhesive | Experimental | Non carious cervical lesions which will receive composite-resin restorations, with a two step etch-and-rinse adhesive Receives: Procedure: Application of adhesive for the restoration of dental lesions with resin composite |
What is being measured
The primary outcome is the main question the study is designed to answer.
Retention of the restorations
percentage of retained restorations
Measured: 2 years
Recurrent caries during examination
percentage of lesion with recurrent caries
Measured: 2 years
Marginal adaptation of the restorations
Measured in μm
Measured: 2 years
Marginal discolouration of the restorations
percentage of stained lesions
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2020
- Study start21 Jul 2020
- Primary completion1 Oct 2020 (estimated)
- Study completion10 Oct 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Athens
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Effie Pappa, University of Athens
- Investigators
- Effie Pappa, DDs, MSc, PhD, Principal investigator, University of Athens
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04565938
- Sponsor's protocol ID
- 118/12-3-2009
- Status last verified
- Sep 2020
- First submitted
- 22 Sep 2020
- Last updated
- 28 Sep 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Performance of a One-step Self-etch Adhesive in Non-carious Cervical Lesions at 2 Years
- ClinicalTrials.gov ID
- NCT04565938
- Acronym / sponsor ID
- 118/12-3-2009
- Conditions
- Non-carious Cervical Lesions, Adhesive Performance
- Keywords
- One-step Adhesive, Self-etch Adhesive, Non-carious cervical lesions, Clinical trial
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 32 participants (actual)
- Lead sponsor
- University of AthensUniversity, hospital or other
- Study start
- 21 Jul 2020 (actual)
- Primary completion
- 1 Oct 2020 (estimated)
- Study completion
- 10 Oct 2020 (estimated)
- First posted
- 28 Sep 2020 (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.
Objectives: One-step self-etch adhesives are the latest adhesives introduced into the market. The aim of this randomized controlled clinical trial was to test the hypothesis that a one-step self-etch adhesive performs equally well as a two-step etch-and-rinse adhesive.
Materials and methods: Thirty two patients with 96 non-carious cervical lesions received composite-resin restorations (Tetric Evo Ceram - Ivoclar/Vivadent), which were bonded either with a one-step self-etch adhesive (AdheSE One - Ivoclar/Vivadent) with or without enamel etching, or with a two-step etch-and-rinse adhesive (ExiTE - Ivoclar/Vivadent). All restorations were evaluated by two examiners at baseline, 6, 12, 18 and 24 months regarding retention, caries recurrence, marginal integrity and discoloration. Retention loss, severe marginal defects and/or discoloration that needed intervention (repair or replacement) and occurrence of caries, were considered as clinical failures. A logistic regression analysis with generalized estimating equations was used to account for the clustered data (three restorations per patient).
Detailed description
Sample selection Patients, receiving dental treatment in the Clinic of Restorative Dentistry, constituted the selection pool. Written informed consent was obtained from all participants before starting treatment. A total of 32 participants were examined to check if they met the inclusion and exclusion criteria by two precalibrated operative dentistry residents. The qualified patients were recruited in the order in which they reported for the screening session, thus forming a convenience sample.
Patients, irrespective of age and gender, should have at least three non-carious cervical lesions on incisors, canines and premolars of the upper or lower jaw. Each lesion should be located at the cervical third of the buccal side of the tooth, be either at the same level or above the gums, have its cervical wall on dentin, not extend on adjacent surfaces and not exceed 5mm in length, 3mm in height and 1.5mm in depth.
Patients receiving periodontal therapy, presenting high caries activity or TMJ problems needing treatment with mouthguards, were excluded from the study.
A total of thirty two patients with ninety six lesions, were eventually included in the study.
Restoration process
All restorations were performed by only one experienced dentist. All three lesions per patient were restored with Tetric EvoCeram (Ivoclar/Vivadent, AG, Shaan, Lichtenstein) (Table X) following one of next adhesive procedures for each tooth, in a statistical random order:
- st method 1. Mechanical removal of sclerotic dentin with a round bur 2. Enamel beveling 3. Enamel (30sec) and dentin (15sec) etching with phosphoric acid 4. Application of ExciTE (Ivoclar/Vivadent, AG, Shaan, Lichtenstein) (Table X) and curing for 10sec with 800mW/cm2 light intensity (Cure TC-01, Spring Health Products, Inc, Norristown, PA, USA) 5. Composite-resin application using a transparent cervical matrix (Kerr-Hawe, Orange, CA, USA) and curing for 40sec 6. Finishing and polishing
- nd method 1. Mechanical removal of sclerotic dentin with a round bur 2. Enamel beveling 3. Application of AdheSE One (Ivoclar/Vivadent, AG, Shaan, Lichtenstein) (Table X) and curing for 10sec 4. Composite-resin application using a transparent cervical matrix and curing for 40sec 5. Finishing and polishing
- rd method 1. Mechanical removal of sclerotic dentin with a round bur 2. Enamel beveling 3. Enamel (30sec) etching with phosphoric acid 4. Application of AdheSE One and curing for 10sec 5. Composite-resin application using a transparent cervical matrix and curing for 40sec 6. Finishing and polishing
Randomization
The methods were applied in random order (using randomization tables), by which the first randomly selected method was used to restore the tooth with the lowest tooth number (according to the FDI system), the second method was used for the tooth with the second lowest tooth number and the third one for the lowest. In case of more than three lesions, an equal number of restorations with each method was ensured. In instances of an uneven number of restorations placed in one patient, the inequality of number of teeth restored with each method was adjusted for by restoring the lesions with the respective methods in the next patient (again according to the respective randomization tables).
Restoration evaluation
Two experienced and calibrated dentists, not involved with the placement of the restorations and therefore blinded to the group assignment, performed the evaluation. For training purposes, the examiners observed 10 photographs that were representative of each score for each criterion. They evaluated 10 to 15 subjects each on 2 consecutive days. These subjects had cervical restorations and they did not participate in this project. An intraexaminer and interexaminer agreement of at least 85% was necessary before the beginning of the evaluation. All restorations were evaluated at baseline, 6, 12, 18 and 24 months according to ….. criteria. The parameters evaluated were retention of the restoration, marginal integrity, marginal discoloration and recurrent caries (Table X).
The parameters were evaluated using the criteria introduced by Hickel et al. 2007, 2010. The overall clinical effectiveness of the tested adhesives was recorded in terms of retention, marginal integrity, marginal discoloration, caries recurrence. Retention loss, occurrence of caries along the restoration margins, severe marginal defects and/or discoloration that needed clinical intervention (repair or replacement) were considered as clinical failure. The clinical effectiveness of the three methods was compared for the abovementioned parameters.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| one-step self-etch adhesive with enamel etching | Experimental | Procedure: Application of adhesive for the restoration of dental lesions with resin compositeNon carious cervical lesions which will receive composite-resin restorations, with one-step self-etch adhesive with enamel etching |
| one-step self-etch adhesive without enamel etching | Experimental | Procedure: Application of adhesive for the restoration of dental lesions with resin compositeNon carious cervical lesions which will receive composite-resin restorations, with one-step self-etch adhesive without enamel etching |
| two-step etch-and-rinse adhesive | Experimental | Procedure: Application of adhesive for the restoration of dental lesions with resin compositeNon carious cervical lesions which will receive composite-resin restorations, with a two step etch-and-rinse adhesive |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- At least three non-carious cervical lesions on incisors, canines and premolars of the upper or lower jaw. Each lesion should be located at the cervical third of the buccal side of the tooth, be either at the same level or above the gums, have its cervical wall on dentin, not extend on adjacent surfaces and not exceed 5mm in length, 3mm in height and 1.5mm in depth
Key exclusion criteria (1 listed)
- Patients receiving periodontal therapy, presenting high caries activity or TMJ problems needing treatment with mouthguards, were excluded from the study.
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 |
|---|---|---|
| Application of adhesive for the restoration of dental lesions with resin composite1. Mechanical removal of sclerotic dentin with a round bur 2. Enamel beveling 3. Enamel (30sec) and dentin (15sec) etching with phosphoric acid 4. Application of ExciTE (Ivoclar/Vivadent, AG, Shaan, Lichtenstein) and curing for 10sec with 800mW/cm2 light intensity (Cure TC-01, Spring Health Products, Inc, Norristown, PA, USA) 5. Composite-resin application using a transparent cervical matrix (Kerr-Hawe, Orange, CA, USA) and curing for 40sec 6. Finishing and polishing | Procedure or surgery | two-step etch-and-rinse adhesive |
| Application of adhesive for the restoration of dental lesions with resin composite1. Mechanical removal of sclerotic dentin with a round bur 2. Enamel beveling 3. Application of AdheSE One (Ivoclar/Vivadent, AG, Shaan, Lichtenstein) and curing for 10sec 4. Composite-resin application using a transparent cervical matrix and curing for 40sec 5. Finishing and polishing | Procedure or surgery | one-step self-etch adhesive without enamel etching |
| Application of adhesive for the restoration of dental lesions with resin composite1. Mechanical removal of sclerotic dentin with a round bur 2. Enamel beveling 3. Enamel (30sec) etching with phosphoric acid 4. Application of AdheSE One and curing for 10sec 5. Composite-resin application using a transparent cervical matrix and curing for 40sec 6. Finishing and polishing | Procedure or surgery | one-step self-etch adhesive with enamel etching |
Primary outcome
Retention of the restorations
Time frame: 2 years
percentage of retained restorations
Recurrent caries during examination
Time frame: 2 years
percentage of lesion with recurrent caries
Marginal adaptation of the restorations
Time frame: 2 years
Measured in μm
Marginal discolouration of the restorations
Time frame: 2 years
percentage of stained lesions
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2020.
- 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.
Effie Pappa, DDs, MSc, PhD principal investigator
University of Athens
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Application of adhesive for the restoration of dental lesions with resin composite in people with Non-carious Cervical Lesions and Adhesive Performance, run by University of Athens at 1 site in Greece.
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 1 inclusion and 1 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 28 Sep 2020. 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 Greece. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 of the restorations (time frame: 2 years). The study lists 4 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 28 Sep 2020.