Selective Enamel Etching in Self-etching Adhesives: a 2-year Clinical Trial
Not Applicable
Completed
- Conditions
- Selective Enamel Etching in Dental Restorations
- Interventions
- Drug: Selective enamel etching with 36% phosphoric acidDevice: Xeno VDevice: Clearfil SE Bond
- Registration Number
- NCT02419157
- Lead Sponsor
- University of Guarulhos
- 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.
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 25
Inclusion Criteria
- 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.
Exclusion Criteria
- Compromised medical history;
- Severe or chronic periodontitis;
- Extreme caries sensitivity;
- Heavy bruxism;
- Under orthodontic treatment;
- Poor oral hygiene;
- Smokers.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Xeno V+ Non-etch (XV-NE) No selective enamel etching with 36% phosphoric acid 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 Xeno V+ Non-etch (XV-NE) Xeno V 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 Clearfil SE Bond Etch (CSE-E) Clearfil SE Bond 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 Clearfil SE Bon Non-etch (CSE-NE) Clearfil SE Bond 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 Xeno V+ Etch (XV-E) Xeno V 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 Clearfil SE Bond Etch (CSE-E) Selective enamel etching with 36% phosphoric acid 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 Xeno V+ Etch (XV-E) Selective enamel etching with 36% phosphoric acid 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 Clearfil SE Bon Non-etch (CSE-NE) No selective enamel etching with 36% phosphoric acid 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
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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 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