Tooth WearNCT06227715
Non-Carious Cervical Lesions Restorations Using Different Modes of Universal Adhesive
A study testing universal adhesive in people with Tooth Wear, run by Eskisehir Osmangazi University.
Trial summary
Objectives: To evaluate the 36-month clinical performance of Single Bond Universal Adhesive (SBU; 3M ESPE, Germany) in non-carious cervical lesions (NCCLs) using different modes adhesion approaches according to the FDI criteria. Read more about this study
- Who is it for?
- Ages 20 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Tooth Wear
- What is being tested?
- universal adhesive
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- No sites listed yet
- Study dates
- 28 Apr 2016to 28 Nov 2023
- 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 20 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- At least 20 teeth and 6 NCCL
- The absence of common caries
- The use of universal adhesive and nanohybrid resin composite
Who cannot join
- Candidates with poor oral hygiene
- Acute or chronic periodontal disease
- Xerostomia,
- Malocclusion were excluded.
About this study
Objectives: To evaluate the 36-month clinical performance of Single Bond Universal Adhesive (SBU; 3M ESPE, Germany) in non-carious cervical lesions (NCCLs) using different modes adhesion approaches according to the FDI criteria.
Material and methods: SBU Adhesive was applied in 252 NCCLs of 25 patients using different modes adhesion approaches: Self-etch (SE), selective-enamel-etching (SLE), total-etch (TE). All lesions were restored with nanohybrid resin composite. Restorations were evaluated at baseline, 6th, 12th, 18th, and 36th month using the FDI criteria. IBM SPSS Statistics for Windows, Version 24.0. program was used in the analysis. Differences between SE, SLE and TE groups were tested using Kruskal Wallis test. A value of p<0.05 was accepted as a criterion for statistical significance.
Read the detailed description
Study Design Non-Interventional Clinical Research Ethics Committee (80558721/G-109) approved the study. All participants were informed of the study and consent forms were obtained. The experimental design adhered to the Consolidated Standards of Reporting Trials (CONSORT) statements. For this retrospective study, between May 2015 and July 2015, 102 patients who were diagnosed with non-carious cervical lesion and had their restoration completed in Faculty of Dentistry by single operative dentist. 25 volunteers (10-females, 15-males) with the ages ranging from 35 to 72, 252 restorations were selected for this study according to predetermined criteria (table 1).
Sample Size Calculation G* Power statistical software was used to calculate the sample size. For an effect size (Cohen 'D Effect Size) difference of 0.30 between the groups with 99% power, DF=2 and an alpha error of 5%, at least 238 restorations were needed.
Patient Selection Adults who achieved the inclusion/exclusion criteria and required restoration of at least one notch shaped NCCL were included in the study. Inclusion criteria were the presence of at least 20 teeth and 6 NCCL, the absence of common caries, and the use of universal adhesive and nanohybrid resin composite. Candidates with poor oral hygiene, acute or chronic periodontal disease, xerostomia, and malocclusion were excluded.
The patient forms, in which the identity information of the patients participating in the study and the size of the lesion in the restored teeth, the type and mode of adhesive used in the restoration, and the restorative material were recorded, were reviewed and the necessary tooth groupings were made following the recorded data.
Application Procedure of Restorations The NCCL dimensions in millimeters (height and width) were determined with a digital caliper. Prior to the restoration procedures, a pumice stone and water were used for prophylactic purposes, then the dentin was abraded and beveled to the enamel surface (1-2 mm). Before the restoration of the lesions, isolation was achieved with the use of retraction cord (Ultrapak, Ultradent Products, USA) and cotton rolls. Three different application modes of the universal dentin bonding (Single Bond Universal, 3M ESPE, Germany) adhesive were applied in the restoration of the teeth (table 2). These are TE, in which both dentin and enamel are etched, SLE, in which only enamel is etched, and SE, in which only the adhesive is applied. Each mode of the universal adhesive used in the mouth of each of the patients evaluated was applied to at least two teeth. In accordance with the recommendations of the manufacturer; in TE mode, enamel and dentin were etched with 37% orthophosphoric acid for 15 seconds, washed for 15 seconds, and after air-drying, the adhesive was applied to enamel and dentin by rubbing for 20 seconds. In SLE mode, only enamel margin was etched for 15 seconds, washed for 15 seconds and dried, and the adhesive was applied to the dentin and enamel by rubbing for 20 seconds. In SE mode, the adhesive was applied to the dentin and enamel by rubbing for 20 seconds. After the adhesive was applied in all modes, it was dried for 5 seconds gently and polymerized 10 seconds using a curing light (SmartLite Focus, Dentsply Sirona, USA). Afterwards, all of them were restored with the same nanohybrid resin composite (Filtek Z550, 3M ESPE, USA) in accordance with the layering technique. Restorations were completed by polishing under water cooling with fine diamond burs (GZ Instrumente, Austria) and polishing discs (Soflex Finishing and Polishing Disc, 3M ESPE, USA).
Assessment of Restorations At the 1st, 6th, 12th, 18th, and 36th month, the restorations were evaluated based on the FDI criteria and the results were recorded on the clinical research follow-up form. Two calibrated experienced dentists evaluated the restorations without knowing which adhesive technique was used on which patient, except for the treating dentist, using a mirror and sond under reflector light.
Restorations were evaluated marginal staining, fracture of material and retention, marginal adaptation, post-operative sensitivity and vitality, recurrence of caries, erosion and abfraction, tooth integrity according to the FDI criteria. According to the FDI criteria, these variables were ranked as follows: clinically very good (1), clinically good (2), clinically satisfactory (3), clinically unsatisfactory (4), and clinically poor (5). In accordance with these criteria, values of 1,2 and 3 are clinically acceptable, while 4 and 5 are considered clinically not acceptable.16 The difference between the adhesive modes and the time-dependent variation within each mode were evaluated. Among the evaluated restorations, those with retention loss were evaluated only according to the retention loss criteria and scored with 5 and were not evaluated in terms of other criteria. Restorations that were unsuccessful due to either loss of retention or irreparable secondary caries were replaced with new composite resin restorations. These new restorations were then excluded from the study for further evaluation.
Statistical Analysis Descriptive statistics were used to present the frequency distributions. Shapiro Wilk's test was performed to evaluate the normality of data distribution and it was seen that data were not normally distributed. Differences between SE, SLE and TE groups were tested using Kruskal Wallis test. The was used to compare the groups at baseline, 6, 12, 18 and 36 months. To compare the data in marginal staining, fracture of material and retention, marginal adaptation, post-operative sensitivity and vitality, recurrence of caries, erosion and abfraction, tooth integrity within each group by time, further analyses were carried out using the K Releated Samples and Wilcoxon tests. IBM SPSS Statistics for Windows, Version 24.0. (Armonk, NY: IBM Corp., USA) program was used in the analysis. A value of p<0.05 was accepted as a criterion for statistical significance.
- Conditions
- Tooth Wear
- Being tested
- universal adhesive
- Keywords
- nccl, universal bond, acid etching, selective etching
- Medical subject headings
- Tooth Wear
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
universal adhesiveOther
| Study group | Role | What they receive |
|---|---|---|
| selective etch | Other | In SLE mode, only enamel margin was etched for 15 seconds, washed for 15 seconds and dried, and the adhesive was applied to the dentin and enamel by rubbing for 20 seconds. Receives: Other: universal adhesive |
| Total etch | Other | Each mode of the universal adhesive used in the mouth of each of the patients evaluated was applied to at least two teeth. In accordance with the recommendations of the manufacturer; in TE mode, enamel and dentin were etched with 37% orthophosphoric acid for 15 seconds, washed for 15 seconds, and after air-drying, the adhesive was applied to enamel and dentin by rubbing for 20 seconds. Receives: Other: universal adhesive |
| self etch | Other | In SE mode, the adhesive was applied to the dentin and enamel by rubbing for 20 seconds. Receives: Other: universal adhesive |
What is being measured
The primary outcome is the main question the study is designed to answer.
Non-Carious Cervical Lesions Restorations Using Different Modes of Universal Adhesive
Restorations were evaluated marginal staining, fracture of material and retention, marginal adaptation, post-operative sensitivity and vitality, recurrence of caries, erosion and abfraction, tooth integrity according to the FDI criteria.
Clinically excellent/very good (1) Clinically good (after polishing very good) (2) Clinically sufficient/satisfactory (minor shortcomings, no unacceptable effects but not adjustable w/o damage to the tooth) (3) Clinically unsatis- factory (but reparable) (4) Clinically poor (replacement necessary) (5)
Measured: 6, 12, 18, 36, 60 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2024
- Study start28 Apr 2016
- Primary completion28 Oct 2018
- Study completion28 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Tooth WearStudies 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eskisehir Osmangazi University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hatice Tepe, Eskisehir Osmangazi University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06227715
- Sponsor's protocol ID
- 80558721/G-109
- Status last verified
- Jan 2024
- First submitted
- 21 Dec 2023
- Last updated
- 29 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Tepe H, Celiksoz O, Yaman BC. Clinical evaluation of single bond universal adhesive in non-carious cervical lesions: a 36-month retrospective study. Clin Oral Investig. 2024 Dec 28;29(1):33. doi: 10.1007/s00784-024-06126-y.
PubMed 39731636
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non-Carious Cervical Lesions Restorations Using Different Modes of Universal Adhesive
- ClinicalTrials.gov ID
- NCT06227715
- Acronym / sponsor ID
- 80558721/G-109
- Conditions
- Tooth Wear
- Keywords
- nccl, universal bond, acid etching, selective etching
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Eskisehir Osmangazi UniversityUniversity, hospital or other
- Study start
- 28 Apr 2016 (actual)
- Primary completion
- 28 Oct 2018 (actual)
- Study completion
- 28 Nov 2023 (actual)
- First posted
- 29 Jan 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.
Objectives: To evaluate the 36-month clinical performance of Single Bond Universal Adhesive (SBU; 3M ESPE, Germany) in non-carious cervical lesions (NCCLs) using different modes adhesion approaches according to the FDI criteria.
Material and methods: SBU Adhesive was applied in 252 NCCLs of 25 patients using different modes adhesion approaches: Self-etch (SE), selective-enamel-etching (SLE), total-etch (TE). All lesions were restored with nanohybrid resin composite. Restorations were evaluated at baseline, 6th, 12th, 18th, and 36th month using the FDI criteria. IBM SPSS Statistics for Windows, Version 24.0. program was used in the analysis. Differences between SE, SLE and TE groups were tested using Kruskal Wallis test. A value of p<0.05 was accepted as a criterion for statistical significance.
Detailed description
Study Design Non-Interventional Clinical Research Ethics Committee (80558721/G-109) approved the study. All participants were informed of the study and consent forms were obtained. The experimental design adhered to the Consolidated Standards of Reporting Trials (CONSORT) statements. For this retrospective study, between May 2015 and July 2015, 102 patients who were diagnosed with non-carious cervical lesion and had their restoration completed in Faculty of Dentistry by single operative dentist. 25 volunteers (10-females, 15-males) with the ages ranging from 35 to 72, 252 restorations were selected for this study according to predetermined criteria (table 1).
Sample Size Calculation G* Power statistical software was used to calculate the sample size. For an effect size (Cohen 'D Effect Size) difference of 0.30 between the groups with 99% power, DF=2 and an alpha error of 5%, at least 238 restorations were needed.
Patient Selection Adults who achieved the inclusion/exclusion criteria and required restoration of at least one notch shaped NCCL were included in the study. Inclusion criteria were the presence of at least 20 teeth and 6 NCCL, the absence of common caries, and the use of universal adhesive and nanohybrid resin composite. Candidates with poor oral hygiene, acute or chronic periodontal disease, xerostomia, and malocclusion were excluded.
The patient forms, in which the identity information of the patients participating in the study and the size of the lesion in the restored teeth, the type and mode of adhesive used in the restoration, and the restorative material were recorded, were reviewed and the necessary tooth groupings were made following the recorded data.
Application Procedure of Restorations The NCCL dimensions in millimeters (height and width) were determined with a digital caliper. Prior to the restoration procedures, a pumice stone and water were used for prophylactic purposes, then the dentin was abraded and beveled to the enamel surface (1-2 mm). Before the restoration of the lesions, isolation was achieved with the use of retraction cord (Ultrapak, Ultradent Products, USA) and cotton rolls. Three different application modes of the universal dentin bonding (Single Bond Universal, 3M ESPE, Germany) adhesive were applied in the restoration of the teeth (table 2). These are TE, in which both dentin and enamel are etched, SLE, in which only enamel is etched, and SE, in which only the adhesive is applied. Each mode of the universal adhesive used in the mouth of each of the patients evaluated was applied to at least two teeth. In accordance with the recommendations of the manufacturer; in TE mode, enamel and dentin were etched with 37% orthophosphoric acid for 15 seconds, washed for 15 seconds, and after air-drying, the adhesive was applied to enamel and dentin by rubbing for 20 seconds. In SLE mode, only enamel margin was etched for 15 seconds, washed for 15 seconds and dried, and the adhesive was applied to the dentin and enamel by rubbing for 20 seconds. In SE mode, the adhesive was applied to the dentin and enamel by rubbing for 20 seconds. After the adhesive was applied in all modes, it was dried for 5 seconds gently and polymerized 10 seconds using a curing light (SmartLite Focus, Dentsply Sirona, USA). Afterwards, all of them were restored with the same nanohybrid resin composite (Filtek Z550, 3M ESPE, USA) in accordance with the layering technique. Restorations were completed by polishing under water cooling with fine diamond burs (GZ Instrumente, Austria) and polishing discs (Soflex Finishing and Polishing Disc, 3M ESPE, USA).
Assessment of Restorations At the 1st, 6th, 12th, 18th, and 36th month, the restorations were evaluated based on the FDI criteria and the results were recorded on the clinical research follow-up form. Two calibrated experienced dentists evaluated the restorations without knowing which adhesive technique was used on which patient, except for the treating dentist, using a mirror and sond under reflector light.
Restorations were evaluated marginal staining, fracture of material and retention, marginal adaptation, post-operative sensitivity and vitality, recurrence of caries, erosion and abfraction, tooth integrity according to the FDI criteria. According to the FDI criteria, these variables were ranked as follows: clinically very good (1), clinically good (2), clinically satisfactory (3), clinically unsatisfactory (4), and clinically poor (5). In accordance with these criteria, values of 1,2 and 3 are clinically acceptable, while 4 and 5 are considered clinically not acceptable.16 The difference between the adhesive modes and the time-dependent variation within each mode were evaluated. Among the evaluated restorations, those with retention loss were evaluated only according to the retention loss criteria and scored with 5 and were not evaluated in terms of other criteria. Restorations that were unsuccessful due to either loss of retention or irreparable secondary caries were replaced with new composite resin restorations. These new restorations were then excluded from the study for further evaluation.
Statistical Analysis Descriptive statistics were used to present the frequency distributions. Shapiro Wilk's test was performed to evaluate the normality of data distribution and it was seen that data were not normally distributed. Differences between SE, SLE and TE groups were tested using Kruskal Wallis test. The was used to compare the groups at baseline, 6, 12, 18 and 36 months. To compare the data in marginal staining, fracture of material and retention, marginal adaptation, post-operative sensitivity and vitality, recurrence of caries, erosion and abfraction, tooth integrity within each group by time, further analyses were carried out using the K Releated Samples and Wilcoxon tests. IBM SPSS Statistics for Windows, Version 24.0. (Armonk, NY: IBM Corp., USA) program was used in the analysis. A value of p<0.05 was accepted as a criterion for statistical significance.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| selective etch | Other | Other: universal adhesiveIn SLE mode, only enamel margin was etched for 15 seconds, washed for 15 seconds and dried, and the adhesive was applied to the dentin and enamel by rubbing for 20 seconds. |
| Total etch | Other | Other: universal adhesiveEach mode of the universal adhesive used in the mouth of each of the patients evaluated was applied to at least two teeth. In accordance with the recommendations of the manufacturer; in TE mode, enamel and dentin were etched with 37% orthophosphoric acid for 15 seconds, washed for 15 seconds, and after air-drying, the adhesive was applied to enamel and dentin by rubbing for 20 seconds. |
| self etch | Other | Other: universal adhesiveIn SE mode, the adhesive was applied to the dentin and enamel by rubbing for 20 seconds. |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- At least 20 teeth and 6 NCCL
- The absence of common caries
- The use of universal adhesive and nanohybrid resin composite
Key exclusion criteria (4 listed)
- Candidates with poor oral hygiene
- Acute or chronic periodontal disease
- Xerostomia,
- Malocclusion were excluded.
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 |
|---|---|---|
| universal adhesive | Other | Total etch, selective etch, self etch |
Primary outcome
Non-Carious Cervical Lesions Restorations Using Different Modes of Universal Adhesive
Time frame: 6, 12, 18, 36, 60 month
Restorations were evaluated marginal staining, fracture of material and retention, marginal adaptation, post-operative sensitivity and vitality, recurrence of caries, erosion and abfraction, tooth integrity according to the FDI criteria. Clinically excellent/very good (1) Clinically good (after polishing very good) (2) Clinically sufficient/satisfactory (minor shortcomings, no unacceptable effects but not adjustable w/o damage to the tooth) (3) Clinically unsatis- factory (but reparable) (4) Clinically poor (replacement necessary) (5)
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 29 Jan 2024.
- Derived from this study: PubMed 39731636Tepe H, Celiksoz O, Yaman BC. Clinical evaluation of single bond universal adhesive in non-carious cervical lesions: a 36-month retrospective study. Clin Oral Investig. 2024 Dec 28;29(1):33. doi: 10.1007/s00784-024-06126-y.
- FDI Criteria for dental restorationsLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing universal adhesive in people with Tooth Wear, run by Eskisehir Osmangazi University.
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 3 inclusion and 4 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 29 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
Non-Carious Cervical Lesions Restorations Using Different Modes of Universal Adhesive (time frame: 6, 12, 18, 36, 60 month). 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 NCT06227715, which also lists 1 linked publication.
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 29 Jan 2024.