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

NCT02419157 | Completed DMC

• 1 other identifier: PRGRE 2015
• Study Type: interventional
• Target: 25
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Selective Enamel Etching in Dental Restorations

Keywords

Cervical lesions; Clinical trial; Self-etch adhesive

Outcome Measures

Primary Outcomes (1)

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

  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

  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

  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

  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

  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

  Baseline, 3, 6, 12, 18 and 24 months

Study Arms (4)

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

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

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

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

Drug: No selective enamel etching with 36% phosphoric acid; Device: Xeno V

Interventions

Selective enamel etching with 36% phosphoric acid DRUG

Etch: selective 36% phosphoric acid enamel etching

Also known as: 36% phosphoric acid

Clearfil SE Bond Etch (CSE-E); Xeno V+ Etch (XV-E)

No selective enamel etching with 36% phosphoric acid DRUG

Non-etch: without phosphoric acid selective enamel etching

Also known as: Without 36% phosphoric acid

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)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• University of Guarulhos: lead

Related Publications (7)

• 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.

  PMID: 15668328 BACKGROUND

• 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.

  PMID: 15765956 BACKGROUND

• 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.

  PMID: 12638771 BACKGROUND

• 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.

  PMID: 17432395 BACKGROUND

• 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.

  PMID: 15766585 BACKGROUND

• 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.

  PMID: 17302950 BACKGROUND

• 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.

  PMID: 16315023 BACKGROUND

MeSH Terms

Interventions

phosphoric acid

Study Officials

• André F Reis

  University of Guarulhos

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Faculty

Study Record Dates

• First Submitted: March 29, 2015
• First Posted: April 17, 2015
• Study Start: October 1, 2012
• Primary Completion: October 1, 2014
• Study Completion: October 1, 2014
• Last Updated: April 17, 2015

Record last verified: 2015-04