Non-carious Cervical LesionsNCT06474494
Evaluation of Double Layer Application Using a Universal Adhesive in the Quality of Cervical Lesions Restorations
A study testing Application of one layer, Application of double layer and Etch-and-rinse application mode in people with Non-carious Cervical Lesions, run by Universidad de los Andes, Chile at 1 site in Chile.
Trial summary
The aim of this study will be to evaluate the effect of a double layer application of a universal adhesive system used as etch-and-rinse application mode in non-carious cervical lesions (NCCLs), on the 6- and 12-months clinical performance. Read more about this study
- Who is it for?
- Ages 18 to 99 yearsHealthy volunteers can take part
- Conditions the study is for
- Non-carious Cervical Lesions
- What is being tested?
- Application of one layer, Application of double layer and Etch-and-rinse application mode
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteChile
- Study dates
- 1 Mar 2024to 1 Mar 2024
- 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 99 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients older than 18 years.
- Presence of at least two Non-Carious Cervical Lesions in the dental arch with a need for restorative treatment.
- Acceptable level of oral hygiene according to the Simplified Oral Hygiene Index.
- At least 20 teeth in function.
- Non-Carious Cervical Lesions with a maximum of 50% of enamel margin.
Who cannot join
- Driving difficulties that prevent adequate oral hygiene.
- Periodontal disease.
- Active caries lesions on the teeth included in the research.
- Parafunctional habits.
- Active staples of removable partial dentures on the teeth included in the research and that these are not pillars of prostheses.
Trial locations and contacts
1 site in 1 country.
Chile1 site
Mario Felipe Gutiérrez Reyes
Santiago, Santiago Metropolitan, 8360053
About this study
Official title: Clinical Evaluation of the Effect of Double Layer Application Using a Universal Adhesive in Restorations of Non-carious Cervical Lesions: Double-blind Randomized Clinical Trial
The aim of this study will be to evaluate the effect of a double layer application of a universal adhesive system used as etch-and-rinse application mode in non-carious cervical lesions (NCCLs), on the 6- and 12-months clinical performance.
Materials \& Methods: 144 restorations were randomly placed in 36 subjects (16 male and 20 female) according to the following groups (n=36): ER1 (one layer of Scotchbond Universal Plus adhesive applied as etch-and-rinse mode); ER2 (double layer of Scotchbond Universal Plus adhesive applied as etch-and-rinse mode); SEE1 (one layer of Scotchbond Universal Plus adhesive applied as selective enamel etching); SEE2 (double layer of Scotchbond Universal Plus adhesive applied as selective enamel etching). All groups were light-cured for 10s/1,000 mW/cm2 only after final layer. A resin composite will be placed by applying three increments and each one will be light cured for 20s/1,000 mW/cm2. The restorations will be finished immediately with fine diamond burs and polishers. The restorations will be evaluated at baseline and after 6- and 12-months by using the FDI criteria. The following outcomes will be evaluated: retention, marginal staining, marginal adaptation, post-operative sensitivity and recurrence of caries. The differences among the groups will be calculated using Friedman repeated measures analysis of variance rank (α = 0.05).
Read the detailed description
This is a four-arm, double-blind, randomized controlled clinical trial. Experimental group 1: 35 non-carious cervical lesions (NCCL) will receive composite resin restorations applying a double layer of Scotchbond Universal Plus adhesive applied as etch-and-rinse mode.
Experimental group 2: 35 non-carious cervical lesions (NCCL) will receive composite resin restorations applying a double layer of Scotchbond Universal Plus adhesive applied as selective enamel etching mode.
Control group 1: 35 non-carious cervical lesions (NCCL) will receive composite resin restorations applying one layer of Scotchbond Universal Plus adhesive applied as etch-and-rinse mode.
Control group 2: 35 non-carious cervical lesions (NCCL) will receive composite resin restorations applying one layer of Scotchbond Universal Plus adhesive applied as selective enamel etching mode.
LCNCs will be randomized to application mode and number of layers. All groups will be light-cured with a light-curing device (SmartLite Focus, Dentsply) with a light intensity of 900 mW/cm² for 10 seconds. Operators will restore the cervical area by applying three increments of resin (Filtek Supreme XT, 3M). Each increment will light cure for 20 s at 900 mW/cm2 (SmartLite Focus, Dentsply). Restorations will be finished immediately with fine and extra fine diamond burs and polished with polishing spirals.
- Conditions
- Non-carious Cervical Lesions
- Being tested
- Application of one layer, Application of double layer, Etch-and-rinse application mode, Selective enamel etching application mode
- Keywords
- Dental bonding, Tooth erosion, Tooth wear, Adhesive systems, Double layer
- Medical subject headings
- Tooth Erosion, Tooth Wear
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Application of one layerProcedure or surgery
35 non-carious cervical lesions (NCCL) will receive composite resin restorations applying one layer of Scotchbond Universal Plus adhesive
Application of double layerProcedure or surgery
35 non-carious cervical lesions (NCCL) will receive composite resin restorations applying double layer of Scotchbond Universal Plus adhesive
Etch-and-rinse application modeProcedure or surgery
35 non-carious cervical lesions (NCCL) will receive composite resin restorations applying Scotchbond Universal Plus adhesive applied as etch-and-rinse application mode
Selective enamel etching application modeProcedure or surgery
35 non-carious cervical lesions (NCCL) will receive composite resin restorations applying Scotchbond Universal Plus adhesive applied as selective enamel etching mode
| Study group | Role | What they receive |
|---|---|---|
| Experimental: Experimental group 1 | Experimental | 35 non-carious cervical lesions (NCCL) will receive composite resin restorations applying double layer of Scotchbond Universal Plus adhesive applied as etch-and-rinse mode Receives: Procedure: Application of double layer; Procedure: Etch-and-rinse application mode |
| Experimental group 2 | Experimental | 35 non-carious cervical lesions (NCCL) will receive composite resin restorations applying double layer of Scotchbond Universal Plus adhesive applied as selective enamel etching mode Receives: Procedure: Application of double layer; Procedure: Selective enamel etching application mode |
| Control group 1 | Active comparator | 35 non-carious cervical lesions (NCCL) will receive composite resin restorations applying one layer of Scotchbond Universal Plus adhesive applied as etch-and-rinse mode Receives: Procedure: Application of one layer; Procedure: Etch-and-rinse application mode |
| Control group 2 | Active comparator | 35 non-carious cervical lesions (NCCL) will receive composite resin restorations applying one layer of Scotchbond Universal Plus adhesive applied as selective enamel etching mode Receives: Procedure: Application of one layer; Procedure: Selective enamel etching application mode |
What is being measured
The primary outcome is the main question the study is designed to answer.
Retention rate of restorations
Retention rate measured by World Dental Federation (FDI) criteria as following:
- G: Clinically good - Small hairline crack;
- SS: Clinically sufficient/satisfactory - Two or more or larger hairline cracks and/or chipping (not affecting the marginal integrity);
- US: Clinically unsatisfactory - Chipping fractures which damage marginal quality; bulk fractures with or without partial loss (less than half of the restoration);
- PO: Clinically poor - (Partial or complete) loss of restoration, (replacement necessary).
Measured: From date of randomization until twenty four months
Secondary outcomes (2)
Marginal Adaptation rate of restorations
Marginal Adaptation rate measured by World Dental Federation (FDI) criteria as following:
- VG: Clinically very good - Harmonious outline, no gaps, no discoloration;
- G: Clinically good - Small marginal fracture removable by polishing;
- SS: Clinically sufficient/satisfactory - Several small enamel or dentin fractures;
- US: Clinically unsatisfactory - Notable enamel or dentine wall fracture;
- PO: Clinically poor - Filling is loose but in situ.
Measured: From date of randomization until twenty four months
Marginal Staining rate of restorations
Marginal Staining rate measured by World Dental Federation (FDI) criteria as following:
- VG: Clinically very good - No marginal staining;
- G: Clinically good - Minor marginal staining, easily removable by polishing;
- SS: Clinically sufficient/satisfactory - Moderate marginal staining, not esthetically unacceptable;
- US: Clinically unsatisfactory - Pronounced marginal staining; major intervention necessary for improvement;
- PO: Clinically poor - Deep marginal staining not accessible for intervention
Measured: From date of randomization until twenty four months]
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2024
- Study start1 Mar 2024
- Primary completion1 Mar 2024
- Study completion1 Mar 2024
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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is a four-arm, double-blind, randomized controlled clinical trial. Experimental group 1: 35 non-carious cervical lesions (NCCL) will receive composite resin restorations applying a double layer of Scotchbond Universal Plus adhesive applied as etch-and-rinse mode. Experimental group 2: 35 non-carious cervical lesions (NCCL) will receive composite resin restorations applying a double layer of Scotchbond Universal Plus adhesive applied as selective enamel etching mode. Control group 1: 35 non-carious cervical lesions (NCCL) will receive composite resin restorations applying one layer of Scotchbond Universal Plus adhesive applied as etch-and-rinse mode. Control group 2: 35 non-carious cervical lesions (NCCL) will receive composite resin restorations applying one layer of Scotchbond Universal Plus adhesive applied as selective enamel etching mode. LCNCs will be randomized to application mode and number of layers
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad de los Andes, Chile
- Sponsor type
- University, hospital or other
- Collaborators
- Agencia Nacional de Investigación y Desarrollo
- Responsible party
- Principal investigator, Mario Felipe Gutiérrez Reyes, Universidad de los Andes, Chile
- Investigators
- Mario Felipe Gutierrez Reyes, Study director, Universidad de los Andes, Chile
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06474494
- Sponsor's protocol ID
- CEC2024050
- Status last verified
- Jun 2024
- First submitted
- 19 Jun 2024
- Last updated
- 26 Jun 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Evaluation of the Effect of Double Layer Application Using a Universal Adhesive in Restorations of Non-carious Cervical Lesions: Double-blind Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT06474494
- Acronym / sponsor ID
- CEC2024050
- Conditions
- Non-carious Cervical Lesions
- Keywords
- Dental bonding, Tooth erosion, Tooth wear, Adhesive systems, Double layer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Universidad de los Andes, ChileUniversity, hospital or other
- Collaborators
- Agencia Nacional de Investigación y Desarrollo
- Study start
- 1 Mar 2024 (actual)
- Primary completion
- 1 Mar 2024 (actual)
- Study completion
- 1 Mar 2024 (actual)
- First posted
- 25 Jun 2024 (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 this study will be to evaluate the effect of a double layer application of a universal adhesive system used as etch-and-rinse application mode in non-carious cervical lesions (NCCLs), on the 6- and 12-months clinical performance.
Materials \& Methods: 144 restorations were randomly placed in 36 subjects (16 male and 20 female) according to the following groups (n=36): ER1 (one layer of Scotchbond Universal Plus adhesive applied as etch-and-rinse mode); ER2 (double layer of Scotchbond Universal Plus adhesive applied as etch-and-rinse mode); SEE1 (one layer of Scotchbond Universal Plus adhesive applied as selective enamel etching); SEE2 (double layer of Scotchbond Universal Plus adhesive applied as selective enamel etching). All groups were light-cured for 10s/1,000 mW/cm2 only after final layer. A resin composite will be placed by applying three increments and each one will be light cured for 20s/1,000 mW/cm2. The restorations will be finished immediately with fine diamond burs and polishers. The restorations will be evaluated at baseline and after 6- and 12-months by using the FDI criteria. The following outcomes will be evaluated: retention, marginal staining, marginal adaptation, post-operative sensitivity and recurrence of caries. The differences among the groups will be calculated using Friedman repeated measures analysis of variance rank (α = 0.05).
Detailed description
This is a four-arm, double-blind, randomized controlled clinical trial. Experimental group 1: 35 non-carious cervical lesions (NCCL) will receive composite resin restorations applying a double layer of Scotchbond Universal Plus adhesive applied as etch-and-rinse mode.
Experimental group 2: 35 non-carious cervical lesions (NCCL) will receive composite resin restorations applying a double layer of Scotchbond Universal Plus adhesive applied as selective enamel etching mode.
Control group 1: 35 non-carious cervical lesions (NCCL) will receive composite resin restorations applying one layer of Scotchbond Universal Plus adhesive applied as etch-and-rinse mode.
Control group 2: 35 non-carious cervical lesions (NCCL) will receive composite resin restorations applying one layer of Scotchbond Universal Plus adhesive applied as selective enamel etching mode.
LCNCs will be randomized to application mode and number of layers. All groups will be light-cured with a light-curing device (SmartLite Focus, Dentsply) with a light intensity of 900 mW/cm² for 10 seconds. Operators will restore the cervical area by applying three increments of resin (Filtek Supreme XT, 3M). Each increment will light cure for 20 s at 900 mW/cm2 (SmartLite Focus, Dentsply). Restorations will be finished immediately with fine and extra fine diamond burs and polished with polishing spirals.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 4
- Model description
- This is a four-arm, double-blind, randomized controlled clinical trial. Experimental group 1: 35 non-carious cervical lesions (NCCL) will receive composite resin restorations applying a double layer of Scotchbond Universal Plus adhesive applied as etch-and-rinse mode. Experimental group 2: 35 non-carious cervical lesions (NCCL) will receive composite resin restorations applying a double layer of Scotchbond Universal Plus adhesive applied as selective enamel etching mode. Control group 1: 35 non-carious cervical lesions (NCCL) will receive composite resin restorations applying one layer of Scotchbond Universal Plus adhesive applied as etch-and-rinse mode. Control group 2: 35 non-carious cervical lesions (NCCL) will receive composite resin restorations applying one layer of Scotchbond Universal Plus adhesive applied as selective enamel etching mode. LCNCs will be randomized to application mode and number of layers
| Arm | Type | Receives |
|---|---|---|
| Experimental: Experimental group 1 | Experimental | Procedure: Application of double layer, Procedure: Etch-and-rinse application mode35 non-carious cervical lesions (NCCL) will receive composite resin restorations applying double layer of Scotchbond Universal Plus adhesive applied as etch-and-rinse mode |
| Experimental group 2 | Experimental | Procedure: Application of double layer, Procedure: Selective enamel etching application mode35 non-carious cervical lesions (NCCL) will receive composite resin restorations applying double layer of Scotchbond Universal Plus adhesive applied as selective enamel etching mode |
| Control group 1 | Active comparator | Procedure: Application of one layer, Procedure: Etch-and-rinse application mode35 non-carious cervical lesions (NCCL) will receive composite resin restorations applying one layer of Scotchbond Universal Plus adhesive applied as etch-and-rinse mode |
| Control group 2 | Active comparator | Procedure: Application of one layer, Procedure: Selective enamel etching application mode35 non-carious cervical lesions (NCCL) will receive composite resin restorations applying one layer of Scotchbond Universal Plus adhesive applied as selective enamel etching mode |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients older than 18 years.
- Presence of at least two Non-Carious Cervical Lesions in the dental arch with a need for restorative treatment.
- Acceptable level of oral hygiene according to the Simplified Oral Hygiene Index.
- At least 20 teeth in function.
- Non-Carious Cervical Lesions with a maximum of 50% of enamel margin.
Key exclusion criteria (5 listed)
- Driving difficulties that prevent adequate oral hygiene.
- Periodontal disease.
- Active caries lesions on the teeth included in the research.
- Parafunctional habits.
- Active staples of removable partial dentures on the teeth included in the research and that these are not pillars of prostheses.
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 one layer35 non-carious cervical lesions (NCCL) will receive composite resin restorations applying one layer of Scotchbond Universal Plus adhesive | Procedure or surgery | Control group 1, Control group 2 |
| Application of double layer35 non-carious cervical lesions (NCCL) will receive composite resin restorations applying double layer of Scotchbond Universal Plus adhesive | Procedure or surgery | Experimental group 2, Experimental: Experimental group 1 |
| Etch-and-rinse application mode35 non-carious cervical lesions (NCCL) will receive composite resin restorations applying Scotchbond Universal Plus adhesive applied as etch-and-rinse application mode | Procedure or surgery | Control group 1, Experimental: Experimental group 1 |
| Selective enamel etching application mode35 non-carious cervical lesions (NCCL) will receive composite resin restorations applying Scotchbond Universal Plus adhesive applied as selective enamel etching mode | Procedure or surgery | Control group 2, Experimental group 2 |
Primary outcome
Retention rate of restorations
Time frame: From date of randomization until twenty four months
Retention rate measured by World Dental Federation (FDI) criteria as following: * G: Clinically good - Small hairline crack; * SS: Clinically sufficient/satisfactory - Two or more or larger hairline cracks and/or chipping (not affecting the marginal integrity); * US: Clinically unsatisfactory - Chipping fractures which damage marginal quality; bulk fractures with or without partial loss (less than half of the restoration); * PO: Clinically poor - (Partial or complete) loss of restoration, (replacement necessary).
2 secondary outcomes
Marginal Adaptation rate of restorations
Time frame: From date of randomization until twenty four months
Marginal Staining rate of restorations
Time frame: From date of randomization until twenty four months]
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 26 Jun 2024.
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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.
Mario Felipe Gutierrez Reyes study director
Universidad de los Andes, Chile
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Application of one layer, Application of double layer and Etch-and-rinse application mode in people with Non-carious Cervical Lesions, run by Universidad de los Andes, Chile at 1 site in Chile.
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 5 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 26 Jun 2024. 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 Chile. 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?
Retention rate of restorations (time frame: From date of randomization until twenty four months). 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 26 Jun 2024.