Universal Adhesive for Restoring Cervical Lesions
Study Details
Study Description
Brief Summary
With limited evidence-based information in literature about using (BeautiBond Universal), it is beneficial to evaluate the material using a randomized controlled clinical trial to test the null hypothesis that this universal adhesive (BeautiBond Universal) will have the same effect as Prime&Bond universal™ regarding marginal discoloration and clinical performance.
Condition or Disease | Intervention/Treatment | Phase |
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N/A |
Detailed Description
Cervical restorations are ever challenging because of difficulties in moisture control, caries access, and proximity to gingival margin. Both mechanical and the non-mechanical factors act to hinder the longevity of the cervical restoration newer materials are readily introduced in the market with improved chemicomechanical properties, longevity, patient safety and comfort.
The introduction of new-generation adhesive systems has aimed at reducing technique sensitivity and the number of clinical steps required for adhesion. There has been a trend toward the use of less time-consuming options, continuing this trend, universal adhesives have recently been introduced to the profession. However, because of the recent introduction of universal adhesives, little information is currently available about the bond durability of universal adhesives to various substrates. Evaluation of bond durability is important, since the stability of the bond between the adhesive and substrates is related to the clinical success of restorations. Although the most reliable conclusions about the performance of adhesives in the oral environment are derived from clinical trials.
To evaluate the effectiveness and clinical performance of adhesive systems, the American Dental Association (ADA) recommends clinical trials on non-carious cervical lesions (NCCLs), as composite resin restorations only remain bonded to these lesions by the micromechanical interlocking produced by the adhesive systems . The immediate, short-term, and long-term bonding performance of adhesive systems is then evaluated by retention, marginal integrity, and marginal discoloration. There is many attempts to improve bonding to substrates, bond strength and bond durability, one of these attempts is the newly introduced universal adhesive (BeautiBond ).
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
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Experimental: BeautiBond Universal Adhesive Patients with non-carious cervical lesions will be treated with the BeautiBond universal adhesive system applied in a self-etch approach with (SE) selective enamel etching. |
Other: Universal Adhesive
The NCCLs will receive the universal adhesive system applied in a self-etch approach with (SE) selective enamel etching. Apply etchant (phosphoric acid etching gel 37 %) only on enamel for 15 s Rinse ,for 10 s Air dry to remove excess water, Apply the adhesive to entire bonding surface according to manufacture instructions ,Neo Spectra resin composite will be used. The restorations will be finished and polished immediately with fine diamond burs, rubber points .
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Active Comparator: Prime&Bond universal™ Adhesive Patients with non-carious cervical lesions will be treated with the Prime&Bond universal™ Adhesive system applied in a self-etch approach with (SE) selective enamel etching. |
Other: Universal Adhesive
The NCCLs will receive the universal adhesive system applied in a self-etch approach with (SE) selective enamel etching. Apply etchant (phosphoric acid etching gel 37 %) only on enamel for 15 s Rinse ,for 10 s Air dry to remove excess water, Apply the adhesive to entire bonding surface according to manufacture instructions ,Neo Spectra resin composite will be used. The restorations will be finished and polished immediately with fine diamond burs, rubber points .
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Outcome Measures
Primary Outcome Measures
- Primary outcome (Clinical Performance and marginal staining) [18 months]
FDI (World Dental Federation)criteria
Secondary Outcome Measures
- Fractures and Retention [T0=Baseline immediate postoperative T1= 6 months follow up. T2=12 months follow up. T3=18 months follow up.]
FDI (World Dental Federation)criteria
Eligibility Criteria
Criteria
Inclusion Criteria:
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• Participants had to be in good general health, be at least 18 years old
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have an acceptable oral hygiene level
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Participants were required to have NCCLs in different teeth (anterior or posterior) that needed to be restored.
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These lesions had to be noncarious
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deeper than 1 mm
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involve both the enamel and dentin of vital teeth without mobility.
Exclusion Criteria:
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• Uncooperative behavior, limits the use of adhesive due to hampering of adequate field or isolation techniques throughout the procedure.
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Patients allergic to adhesive material.Patients with extremely poor oral hygiene
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severe or chronic periodontitis
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heavy bruxism habits
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Pulp involvement
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Cairo University
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- universal adhesive