Selective Enamel Etching in Dental RestorationsNCT02419157

Selective Enamel Etching in Self-etching Adhesives: a 2-year Clinical Trial

A study testing Selective enamel etching with 36% phosphoric acid, No selective enamel etching with 36% phosphoric acid and Clearfil SE Bond in people with Selective Enamel Etching in Dental Restorations, run by University of Guarulhos.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

The purpose of this study is to evaluate the clinical effectiveness of non-carious cervical lesions (NCCLs) restored with two self-etching adhesive systems applied with or without selective enamel etching. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Selective Enamel Etching in Dental Restorations
What is being tested?: Selective enamel etching with 36% phosphoric acid, No selective enamel etching with 36% phosphoric acid and Clearfil SE Bond
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 25 participants
Where: No sites listed yet
Study dates: Oct 2012to Oct 2014
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
No healthy volunteers
Adult, Older adult

Who may be able to join

Be at least 18 years;
Present at least 4 NCCLs in vital teeth with margins in enamel and dentin (and its largest area in dentin), independently of teeth location;
Non-smoking;
Read and sign the Statement of Informed Consent.

Who cannot join

Compromised medical history;
Severe or chronic periodontitis;
Extreme caries sensitivity;
Heavy bruxism;
Under orthodontic treatment;
Poor oral hygiene;
Smokers.

About this study

Official title: Effectiveness of One- and Two-step Self-etching Adhesives Applied With or Without Selective Enamel Etching: a 2-year Randomized Controlled Clinical Trial

Read the detailed description

The purpose of this study is to evaluate the clinical effectiveness of non-carious cervical lesions (NCCLs) restored with two self-etching adhesive systems: Clearfil SE Bond (Kuraray Noritake, Japan) and Xeno V + (Dentsply De Trey, Germany) applied with or without 36% phosphoric acid enamel etching. Assessments were at baseline, 3, 6, 12, 18 and 24 months of clinical service.

Conditions: Selective Enamel Etching in Dental Restorations
Being tested: Selective enamel etching with 36% phosphoric acid, No selective enamel etching with 36% phosphoric acid, Clearfil SE Bond, Xeno V
Keywords: Cervical lesions, Clinical trial, Self-etch adhesive

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Selective enamel etching with 36% phosphoric acidDrug
Also called 36% phosphoric acid
Etch: selective 36% phosphoric acid enamel etching
No selective enamel etching with 36% phosphoric acidDrug
Also called Without 36% phosphoric acid
Non-etch: without phosphoric acid selective enamel etching
Clearfil SE BondDevice
Xeno VDevice

Study groups in NCT02419157
Study group	Role	What they receive
Clearfil SE Bond Etch (CSE-E)	Active comparator	CSE-E (n=28): After shade selection, teeth were restored under relative isolation. Lesions were cleaned with pumice and water in a rubber cup followed by rinsing and drying. An enamel bevel of 1-2 mm was prepared with a diamond bur operated in a high-speed handpiece under air-water spray. Enamel margins were selectively etched with 36% phosphoric acid for 15s and subsequently thoroughly rinsed and air-dried. Adhesive system was applied according to manufacturers' instructions and light-cured with an LED for 10s. NCCLs were restored incrementally with a microhybrid composite resin. Increments were light cured for 20s. Afterwards, retraction cord was removed and finishing and polishing were performed with rubber points. Selective enamel etching with 36% phosphoric acid Receives: Drug: Selective enamel etching with 36% phosphoric acid; Device: Clearfil SE Bond
Xeno V+ Etch (XV-E)	Active comparator	XV-E (n=28): After shade selection, teeth were restored under relative isolation. Lesions were cleaned with pumice and water in a rubber cup followed by rinsing and drying. An enamel bevel of 1-2 mm was prepared with a diamond bur operated in a high-speed handpiece under air-water spray. Enamel margins were selectively etched with 36% phosphoric acid for 15s and subsequently thoroughly rinsed and air-dried. Adhesive system was applied according to manufacturers' instructions and light-cured with an LED for 10s. NCCLs were restored incrementally with a microhybrid composite resin. Increments were light cured for 20s. Afterwards, retraction cord was removed and finishing and polishing were performed with rubber points. Selective enamel etching with 36% phosphoric acid Receives: Drug: Selective enamel etching with 36% phosphoric acid; Device: Xeno V
Clearfil SE Bon Non-etch (CSE-NE)	Active comparator	CSE-NE (n=28): After shade selection, teeth were restored under relative isolation. Lesions were cleaned with pumice and water in a rubber cup followed by rinsing and drying. An enamel bevel of 1-2 mm was prepared with a diamond bur operated in a high-speed handpiece under air-water spray. Adhesive system was applied according to manufacturers' instructions and light-cured with an LED for 10s. NCCLs were restored incrementally with a microhybrid composite resin. Increments were light cured for 20s. Afterwards, retraction cord was removed and finishing and polishing were performed with rubber points. No selective enamel etching with 36% phosphoric acid Receives: Drug: No selective enamel etching with 36% phosphoric acid; Device: Clearfil SE Bond
Xeno V+ Non-etch (XV-NE)	Active comparator	XV-NE (n=28): After shade selection, teeth were restored under relative isolation. Lesions were cleaned with pumice and water in a rubber cup followed by rinsing and drying. An enamel bevel of 1-2 mm was prepared with a diamond bur operated in a high-speed handpiece under air-water spray. Adhesive system was applied according to manufacturers' instructions and light-cured with an LED for 10s. NCCLs were restored incrementally with a microhybrid composite resin. Increments were light cured for 20s. Afterwards, retraction cord was removed and finishing and polishing were performed with rubber points. No selective enamel etching with 36% phosphoric acid Receives: Drug: No selective enamel etching with 36% phosphoric acid; Device: Xeno V

What is being measured

The primary outcome is the main question the study is designed to answer.

Restoration retention rate as measured by modified U.S. Public Health Service evaluation criteria at baseline, 3, 6, 12, 18 and 24 months
Measured: Baseline, 3, 6, 12, 18 and 24 months

Secondary outcomes (5)

Restoration marginal integrity as measured by modified U.S. Public Health Service evaluation criteria at baseline, 3, 6, 12, 18 and 24 months
Measured: Baseline, 3, 6, 12, 18 and 24 months
Restoration marginal staining as measured by modified U.S. Public Health Service evaluation criteria at baseline, 3, 6, 12, 18 and 24 months
Measured: Baseline, 3, 6, 12, 18 and 24 months
Secondary caries as measured by modified U.S. Public Health Service evaluation criteria at baseline, 3, 6, 12, 18 and 24 months
Measured: Baseline, 3, 6, 12, 18 and 24 months
Post-operative sensitivity as measured by modified U.S. Public Health Service evaluation criteria at baseline, 3, 6, 12, 18 and 24 months
Measured: Baseline, 3, 6, 12, 18 and 24 months
Pulp vitality as measured by modified U.S. Public Health Service evaluation criteria at baseline, 3, 6, 12, 18 and 24 months
Measured: Baseline, 3, 6, 12, 18 and 24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Oct 2012Oct 2014

First posted17 Apr 2015 (estimated)
Study startOct 2012
Primary completionOct 2014
Study completionOct 2014

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (7)Papers the sponsor has linked to this study.
Other trials for Selective Enamel Etching in Dental RestorationsStudies 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: Crossover
Masking: Double blind
Who is masked: Participant, Outcomes assessor
Enrolment: 25 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02419157
Sponsor's protocol ID: PRGRE 2015
Status last verified: Apr 2015
First submitted: 29 Mar 2015
Last updated: 17 Apr 2015
Results posted: No
Data monitoring committee: Yes

Publications

De Munck J, Van Landuyt K, Peumans M, Poitevin A, Lambrechts P, Braem M, Van Meerbeek B. A critical review of the durability of adhesion to tooth tissue: methods and results. J Dent Res. 2005 Feb;84(2):118-32. doi: 10.1177/154405910508400204.
PubMed 15668328
De Munck J, Vargas M, Iracki J, Van Landuyt K, Poitevin A, Lambrechts P, Van Meerbeek B. One-day bonding effectiveness of new self-etch adhesives to bur-cut enamel and dentin. Oper Dent. 2005 Jan-Feb;30(1):39-49.
PubMed 15765956
Perdigao J, Geraldeli S. Bonding characteristics of self-etching adhesives to intact versus prepared enamel. J Esthet Restor Dent. 2003;15(1):32-41; discussion 42. doi: 10.1111/j.1708-8240.2003.tb00280.x.
PubMed 12638771
Peumans M, De Munck J, Van Landuyt K, Lambrechts P, Van Meerbeek B. Five-year clinical effectiveness of a two-step self-etching adhesive. J Adhes Dent. 2007 Feb;9(1):7-10.
PubMed 17432395
Van Meerbeek B, Kanumilli P, De Munck J, Van Landuyt K, Lambrechts P, Peumans M. A randomized controlled study evaluating the effectiveness of a two-step self-etch adhesive with and without selective phosphoric-acid etching of enamel. Dent Mater. 2005 Apr;21(4):375-83. doi: 10.1016/j.dental.2004.05.008.
PubMed 15766585
Reis AF, Bedran-Russo AK, Giannini M, Pereira PN. Interfacial ultramorphology of single-step adhesives: nanoleakage as a function of time. J Oral Rehabil. 2007 Mar;34(3):213-21. doi: 10.1111/j.1365-2842.2006.01656.x.
PubMed 17302950
Cvar JF, Ryge G. Reprint of criteria for the clinical evaluation of dental restorative materials. 1971. Clin Oral Investig. 2005 Dec;9(4):215-32. doi: 10.1007/s00784-005-0018-z. No abstract available.
PubMed 16315023

Study at a glance

From the registry record, last updated by the sponsor on 17 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Effectiveness of One- and Two-step Self-etching Adhesives Applied With or Without Selective Enamel Etching: a 2-year Randomized Controlled Clinical Trial
ClinicalTrials.gov ID: NCT02419157
Acronym / sponsor ID: PRGRE 2015
Conditions: Selective Enamel Etching in Dental Restorations
Keywords: Cervical lesions, Clinical trial, Self-etch adhesive
Study type: Interventional
Recruitment status: Completed
Enrolment: 25 participants (actual)
Lead sponsor: University of GuarulhosUniversity, hospital or other
Study start: Oct 2012
Primary completion: Oct 2014 (actual)
Study completion: Oct 2014 (actual)
First posted: 17 Apr 2015 (estimated)
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.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Double blind (participant, outcomes assessor)
Number of arms: 4

Arm	Type	Receives
Clearfil SE Bond Etch (CSE-E)	Active comparator	Drug: Selective enamel etching with 36% phosphoric acid, Device: Clearfil SE BondCSE-E (n=28): After shade selection, teeth were restored under relative isolation. Lesions were cleaned with pumice and water in a rubber cup followed by rinsing and drying. An enamel bevel of 1-2 mm was prepared with a diamond bur operated in a high-speed handpiece under air-water spray. Enamel margins were selectively etched with 36% phosphoric acid for 15s and subsequently thoroughly rinsed and air-dried. Adhesive system was applied according to manufacturers' instructions and light-cured with an LED for 10s. NCCLs were restored incrementally with a microhybrid composite resin. Increments were light cured for 20s. Afterwards, retraction cord was removed and finishing and polishing were performed with rubber points. Selective enamel etching with 36% phosphoric acid
Xeno V+ Etch (XV-E)	Active comparator	Drug: Selective enamel etching with 36% phosphoric acid, Device: Xeno VXV-E (n=28): After shade selection, teeth were restored under relative isolation. Lesions were cleaned with pumice and water in a rubber cup followed by rinsing and drying. An enamel bevel of 1-2 mm was prepared with a diamond bur operated in a high-speed handpiece under air-water spray. Enamel margins were selectively etched with 36% phosphoric acid for 15s and subsequently thoroughly rinsed and air-dried. Adhesive system was applied according to manufacturers' instructions and light-cured with an LED for 10s. NCCLs were restored incrementally with a microhybrid composite resin. Increments were light cured for 20s. Afterwards, retraction cord was removed and finishing and polishing were performed with rubber points. Selective enamel etching with 36% phosphoric acid
Clearfil SE Bon Non-etch (CSE-NE)	Active comparator	Drug: No selective enamel etching with 36% phosphoric acid, Device: Clearfil SE BondCSE-NE (n=28): After shade selection, teeth were restored under relative isolation. Lesions were cleaned with pumice and water in a rubber cup followed by rinsing and drying. An enamel bevel of 1-2 mm was prepared with a diamond bur operated in a high-speed handpiece under air-water spray. Adhesive system was applied according to manufacturers' instructions and light-cured with an LED for 10s. NCCLs were restored incrementally with a microhybrid composite resin. Increments were light cured for 20s. Afterwards, retraction cord was removed and finishing and polishing were performed with rubber points. No selective enamel etching with 36% phosphoric acid
Xeno V+ Non-etch (XV-NE)	Active comparator	Drug: No selective enamel etching with 36% phosphoric acid, Device: Xeno VXV-NE (n=28): After shade selection, teeth were restored under relative isolation. Lesions were cleaned with pumice and water in a rubber cup followed by rinsing and drying. An enamel bevel of 1-2 mm was prepared with a diamond bur operated in a high-speed handpiece under air-water spray. Adhesive system was applied according to manufacturers' instructions and light-cured with an LED for 10s. NCCLs were restored incrementally with a microhybrid composite resin. Increments were light cured for 20s. Afterwards, retraction cord was removed and finishing and polishing were performed with rubber points. No selective enamel etching with 36% phosphoric acid

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

Be at least 18 years;
Present at least 4 NCCLs in vital teeth with margins in enamel and dentin (and its largest area in dentin), independently of teeth location;
Non-smoking;
Read and sign the Statement of Informed Consent.

Key exclusion criteria (7 listed)

Compromised medical history;
Severe or chronic periodontitis;
Extreme caries sensitivity;
Heavy bruxism;
Under orthodontic treatment;

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
Selective enamel etching with 36% phosphoric acidAlso: 36% phosphoric acidEtch: selective 36% phosphoric acid enamel etching	Drug	Clearfil SE Bond Etch (CSE-E), Xeno V+ Etch (XV-E)
No selective enamel etching with 36% phosphoric acidAlso: Without 36% phosphoric acidNon-etch: without phosphoric acid selective enamel etching	Drug	Clearfil SE Bon Non-etch (CSE-NE), Xeno V+ Non-etch (XV-NE)
Clearfil SE Bond	Device	Clearfil SE Bon Non-etch (CSE-NE), Clearfil SE Bond Etch (CSE-E)
Xeno V	Device	Xeno V+ Etch (XV-E), Xeno V+ Non-etch (XV-NE)

Primary outcome

Restoration retention rate as measured by modified U.S. Public Health Service evaluation criteria at baseline, 3, 6, 12, 18 and 24 months
Time frame: Baseline, 3, 6, 12, 18 and 24 months

5 secondary outcomes

Restoration marginal integrity as measured by modified U.S. Public Health Service evaluation criteria at baseline, 3, 6, 12, 18 and 24 months
Time frame: Baseline, 3, 6, 12, 18 and 24 months
Restoration marginal staining as measured by modified U.S. Public Health Service evaluation criteria at baseline, 3, 6, 12, 18 and 24 months
Time frame: Baseline, 3, 6, 12, 18 and 24 months
Secondary caries as measured by modified U.S. Public Health Service evaluation criteria at baseline, 3, 6, 12, 18 and 24 months
Time frame: Baseline, 3, 6, 12, 18 and 24 months
Post-operative sensitivity as measured by modified U.S. Public Health Service evaluation criteria at baseline, 3, 6, 12, 18 and 24 months
Time frame: Baseline, 3, 6, 12, 18 and 24 months
Pulp vitality as measured by modified U.S. Public Health Service evaluation criteria at baseline, 3, 6, 12, 18 and 24 months
Time frame: Baseline, 3, 6, 12, 18 and 24 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 17 Apr 2015.
Background: PubMed 15668328De Munck J, Van Landuyt K, Peumans M, Poitevin A, Lambrechts P, Braem M, Van Meerbeek B. A critical review of the durability of adhesion to tooth tissue: methods and results. J Dent Res. 2005 Feb;84(2):118-32. doi: 10.1177/154405910508400204.
Background: PubMed 15765956De Munck J, Vargas M, Iracki J, Van Landuyt K, Poitevin A, Lambrechts P, Van Meerbeek B. One-day bonding effectiveness of new self-etch adhesives to bur-cut enamel and dentin. Oper Dent. 2005 Jan-Feb;30(1):39-49.
Background: PubMed 12638771Perdigao J, Geraldeli S. Bonding characteristics of self-etching adhesives to intact versus prepared enamel. J Esthet Restor Dent. 2003;15(1):32-41; discussion 42. doi: 10.1111/j.1708-8240.2003.tb00280.x.
Background: PubMed 17432395Peumans M, De Munck J, Van Landuyt K, Lambrechts P, Van Meerbeek B. Five-year clinical effectiveness of a two-step self-etching adhesive. J Adhes Dent. 2007 Feb;9(1):7-10.
Background: PubMed 15766585Van Meerbeek B, Kanumilli P, De Munck J, Van Landuyt K, Lambrechts P, Peumans M. A randomized controlled study evaluating the effectiveness of a two-step self-etch adhesive with and without selective phosphoric-acid etching of enamel. Dent Mater. 2005 Apr;21(4):375-83. doi: 10.1016/j.dental.2004.05.008.
Background: PubMed 17302950Reis AF, Bedran-Russo AK, Giannini M, Pereira PN. Interfacial ultramorphology of single-step adhesives: nanoleakage as a function of time. J Oral Rehabil. 2007 Mar;34(3):213-21. doi: 10.1111/j.1365-2842.2006.01656.x.
Background: PubMed 16315023Cvar JF, Ryge G. Reprint of criteria for the clinical evaluation of dental restorative materials. 1971. Clin Oral Investig. 2005 Dec;9(4):215-32. doi: 10.1007/s00784-005-0018-z. No abstract available.

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.

André F Reis principal investigator

University of Guarulhos

Questions about this trial

What is this clinical trial studying?

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 4 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 17 Apr 2015. 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?

Restoration retention rate as measured by modified U.S. Public Health Service evaluation criteria at baseline, 3, 6, 12, 18 and 24 months (time frame: Baseline, 3, 6, 12, 18 and 24 months). 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 NCT02419157, which also lists 7 linked publications.

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 17 Apr 2015.