Cervical LesionsNCT02172664
Clinical Evaluation of a Universal Adhesive in Noncarious Cervical Lesions
A study testing Self etch enamel etching, selective etch protocol and Adhese Universal in people with Cervical Lesions, run by Indiana University at 1 site in United States.
Trial summary
The purpose of this prospective clinical trial will be to evaluate the efficacy of an FDA approved and marketed universal dental adhesive formulation in adult noncarious cervical lesions using self-etch and selective etch approaches. Read more about this study
- Who is it for?
- Ages 20 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Cervical Lesions
- What is being tested?
- Self etch enamel etching, selective etch protocol and Adhese Universal
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2014to May 2018
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 1.1. Inclusion criteria
- Willing to provide written consent and authorization for participation.
- Be between 20 and 75 years of age at the time of recruitment
- Have at least two non-carious cervical lesions present in canine or premolar teeth;
- Anticipates availability for recalls (roughly 6 month, 12 month, and 24 month) through the two-year study period
- The lesions selected will be at least 1 mm in depth (measured with a perio probe) and contain both enamel and dentin margins.
Who cannot join
- 1.2. Exclusion criteria
- Severe medical complications (organ transplants, cancer, immunocompromised, long term antibiotic or steroid therapy);
- Active caries on study teeth;
- Bleeding on probing of study teeth;
- Generalized severe periodontitis;
- Patient reported symptoms (burning mouth, loss or diminished taste, saliva amount too little, needs liquids to eat dry foods) or clinical signs (erythematous tongue, chelitis, lack of pooled saliva) associated with dry mouth;
- Patients determined to be at a high risk of caries as determined by a Caries Risk Assessment
Trial locations and contacts
1 site in 1 country.
United States1 site
Indiana University School of Dentistry
Indianapolis, Indiana, 46202
About this study
The purpose of this prospective clinical trial will be to evaluate the efficacy of an FDA approved and marketed universal dental adhesive formulation in adult noncarious cervical lesions using self-etch and selective etch approaches.
The hypothesis is that using a selective enamel etch with this universal adhesive will enhance the restoration margin performance.
Read the detailed description
The purpose of this prospective clinical trial will be to evaluate the efficacy of a newly formulated universal dental adhesive formulation in adult noncarious cervical lesions using self-etch and selective etch approaches.
Thirty-three patients with at least two non-carious cervical lesions will receive one restoration utilizing the self-etch universal adhesive with no separate enamel etching and another restoration utilizing the universal adhesive and a a selective etch protocol in which in which enamel is etched with 37% phosphoric acid.
After a screening/baseline visit at which the restorative procedures listed above will conducted, the patient will be seen at recall visits after approximately 6, 12 and 24 months to observe sensitivity, retention, marginal discoloration and marginal adaptation.
- Conditions
- Cervical Lesions
- Being tested
- Self etch enamel etching, selective etch protocol, Adhese Universal
- Keywords
- noncarious cervical lesions, dental adhesive, retention, enamel margin discoloration, self etch, selective etch procedures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Self etch enamel etchingProcedure or surgery
Also called Adhese Universal, Ivoclar Vivadent
The adhesive will be applied according to manufacturer's instructions. If the lesion is greater than 2 mm in any dimension, incremental placement of Tetric EvoCeram composite (Ivoclar Vivadent) will occur with the first increment being placed against enamel.
selective etch protocolProcedure or surgery
Total Etch (37% phosphoric acid; Ivoclar) will be placed on the enamel margin with no intentional placement on the dentin within the lesion. The adhesive will then be applied as instructed by the manufacturer. Tetric EvoCeram composite will be placed, light-cured, finished, and polished in the same manner as for the self-etch group.
Adhese UniversalDevice
the universal adhesive, Adhese Universal , will be applied to the selected tooth following manufacturer instructions
| Study group | Role | What they receive |
|---|---|---|
| Adhese Universal with self etch enamel etching | Active comparator | patients will receive one restoration on randomly selected study tooth utilizing the self-etch universal adhesive (Adhese Universal, Ivoclar Vivadent) with no separate enamel etching Receives: Procedure: Self etch enamel etching; Procedure: selective etch protocol; Device: Adhese Universal |
| selective etch protocol followed by Adhese Universal | Experimental | patients will receive one restoration on randomly selected study tooth utilizing a 37% phosphoric acid solution followed by application of self-etch universal adhesive (Adhese Universal, Ivoclar Vivadent) Receives: Procedure: Self etch enamel etching; Procedure: selective etch protocol; Device: Adhese Universal |
What is being measured
The primary outcome is the main question the study is designed to answer.
Retention of Restorations
The primary outcome measure will be restoration retention. In these non-retentive dental lesions, the adhesive will be the only mode of retention. Failure of the adhesive would result in loss of the restoration.
Measured: 6, 12, 24 months
Secondary outcomes (1)
Number of Restoration Margins Marked as Stained or Discolored
The secondary outcome measure was the presence of discoloration of restoration margins as determined by blinded evaluators.
Measured: 6, 12, 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2014 (estimated)
- Study startJun 2014
- Primary completionMay 2018
- Study completionMay 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Cervical LesionsStudies of the same condition, open and under way.
- More trials run by Indiana 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- Indiana University
- Sponsor type
- University, hospital or other
- Collaborators
- Ivoclar Vivadent AG
- Responsible party
- Principal investigator, Jeffrey A. Platt, Indiana University
- Investigators
- Jeffrey A Platt, DDS, Principal investigator, Indiana University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02172664
- Sponsor's protocol ID
- IVOC2014
- Status last verified
- May 2019
- First submitted
- 16 Jun 2014
- Last updated
- 28 May 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Evaluation of a Universal Adhesive in Noncarious Cervical Lesions
- ClinicalTrials.gov ID
- NCT02172664
- Acronym / sponsor ID
- IVOC2014
- Conditions
- Cervical Lesions
- Keywords
- noncarious cervical lesions, dental adhesive, retention, enamel margin discoloration, self etch, selective etch procedures
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- Indiana UniversityUniversity, hospital or other
- Collaborators
- Ivoclar Vivadent AG
- Study start
- Jun 2014
- Primary completion
- May 2018 (actual)
- Study completion
- May 2018 (actual)
- First posted
- 24 Jun 2014 (estimated)
- Results
- Posted 28 May 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this prospective clinical trial will be to evaluate the efficacy of an FDA approved and marketed universal dental adhesive formulation in adult noncarious cervical lesions using self-etch and selective etch approaches.
The hypothesis is that using a selective enamel etch with this universal adhesive will enhance the restoration margin performance.
Detailed description
The purpose of this prospective clinical trial will be to evaluate the efficacy of a newly formulated universal dental adhesive formulation in adult noncarious cervical lesions using self-etch and selective etch approaches.
Thirty-three patients with at least two non-carious cervical lesions will receive one restoration utilizing the self-etch universal adhesive with no separate enamel etching and another restoration utilizing the universal adhesive and a a selective etch protocol in which in which enamel is etched with 37% phosphoric acid.
After a screening/baseline visit at which the restorative procedures listed above will conducted, the patient will be seen at recall visits after approximately 6, 12 and 24 months to observe sensitivity, retention, marginal discoloration and marginal adaptation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Adhese Universal with self etch enamel etching | Active comparator | Procedure: Self etch enamel etching, Procedure: selective etch protocol, Device: Adhese Universalpatients will receive one restoration on randomly selected study tooth utilizing the self-etch universal adhesive (Adhese Universal, Ivoclar Vivadent) with no separate enamel etching |
| selective etch protocol followed by Adhese Universal | Experimental | Procedure: Self etch enamel etching, Procedure: selective etch protocol, Device: Adhese Universalpatients will receive one restoration on randomly selected study tooth utilizing a 37% phosphoric acid solution followed by application of self-etch universal adhesive (Adhese Universal, Ivoclar Vivadent) |
Who may qualify
- Ages
- 20 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 1.1. Inclusion criteria
Key exclusion criteria (7 listed)
- 1.2. Exclusion criteria
- Severe medical complications (organ transplants, cancer, immunocompromised, long term antibiotic or steroid therapy);
- Active caries on study teeth;
- Bleeding on probing of study teeth;
- Generalized severe periodontitis;
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 |
|---|---|---|
| Self etch enamel etchingAlso: Adhese Universal, Ivoclar VivadentThe adhesive will be applied according to manufacturer's instructions. If the lesion is greater than 2 mm in any dimension, incremental placement of Tetric EvoCeram composite (Ivoclar Vivadent) will occur with the first increment being placed against enamel. | Procedure or surgery | Adhese Universal with self etch enamel etching, selective etch protocol followed by Adhese Universal |
| selective etch protocolTotal Etch (37% phosphoric acid; Ivoclar) will be placed on the enamel margin with no intentional placement on the dentin within the lesion. The adhesive will then be applied as instructed by the manufacturer. Tetric EvoCeram composite will be placed, light-cured, finished, and polished in the same manner as for the self-etch group. | Procedure or surgery | Adhese Universal with self etch enamel etching, selective etch protocol followed by Adhese Universal |
| Adhese Universalthe universal adhesive, Adhese Universal , will be applied to the selected tooth following manufacturer instructions | Device | Adhese Universal with self etch enamel etching, selective etch protocol followed by Adhese Universal |
Primary outcome
Retention of Restorations
Time frame: 6, 12, 24 months
The primary outcome measure will be restoration retention. In these non-retentive dental lesions, the adhesive will be the only mode of retention. Failure of the adhesive would result in loss of the restoration.
1 secondary outcome
Number of Restoration Margins Marked as Stained or Discolored
Time frame: 6, 12, 24 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 May 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Jeffrey A Platt, DDS principal investigator
Indiana 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 Self etch enamel etching, selective etch protocol and Adhese Universal in people with Cervical Lesions, run by Indiana University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 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 28 May 2019. 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 United States. 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?
Yes. Results are posted in the registry (first posted 28 May 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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 Restorations (time frame: 6, 12, 24 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 28 May 2019.