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Clinical evaluation of an adhesive containing stabilizate silane in non-carious lesions

Clinical Evaluation of an Universal Adhesive containing Stabilizate Silane in Non-Carious Cervical Lesions: Randomized Clinical Trial, triple-blind.

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
REBEC
Registry ID
RBR-2w3p7z7
Enrollment
Unknown
Registered
2025-08-13
Start date
2025-04-06
Completion date
Unknown
Last updated
2025-10-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Tooth abrasion

Interventions

This is a randomized, equivalence, triple-blind, and two arms clinical trial. A total of 40 participants possessing 2 non-carious cervical lesions (NCCLs) associated with dental abrasion and meeting t
and Group 2 = silane-stabilized adhesive (Single Bond Universal Plus, Solventum, St. Paul. MN. USA) . Operators, evaluators, and patients will be blinded to the material used for treatment. The proced

Sponsors

Universidade Estadual de Ponta Grossa
Lead Sponsor
Universidade Estadual de Ponta Grossa
Collaborator

Eligibility

Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: The inclusion criteria considered patients classified as ASA I or II, aged between 18 and 65 years, who presented good oral hygiene and at least 20 teeth in occlusion. Furthermore, participants should present at least two non-carious cervical lesions (NCCLs) with a depth greater than 1mm.

Exclusion criteria

Exclusion criteria: The exclusion criteria are: individuals with periodontal disease, characterized by probing depth greater than 3 mm, gingival bleeding, or dental mobility of grade II or higher. Also excluded were individuals with parafunctional habits, smokers, orthodontic appliance wearers, teeth serving as prosthetic abutments, and pregnant women. Finally, individuals who did not agree with the research terms or who presented difficulties in attending the necessary follow-ups after the restorations were performed were also excluded from the study.

Design outcomes

Primary

MeasureTime frame
The expected primary outcome is that the average retention rate of restorations performed with the silane-stabilized adhesive is not inferior by more than 25% when compared to the average retention rate of restorations performed with the non-stabilized silane adhesive, as assessed using the Fédération Dentaire Internationale (FDI) criteria at 12 months.

Secondary

MeasureTime frame
It is expected that there will be up to a 25% increase in criteria 3 and 4 (clinically satisfactory and clinically unsatisfactory) for the marginal adaptation of restorations performed with the silane-stabilized adhesive when compared to the retention rate of restorations performed with the non-stabilized slinae adhesive, as evaluated by the World Dental Federation (FDI) criteria after 12 months.;It is expected that there will be up to a 25% increase in criteria 3 and 4 (clinically satisfactory and clinically unsatisfactory) for the marginal stainingv of restorations performed with the silane-stabilized adhesive when compared to the retention rate of restorations performed with the non-stabilized slinae adhesive, as evaluated by the World Dental Federation (FDI) criteria after 12 months.

Countries

Brazil

Contacts

Public ContactAlessandro Loguercio

Universidade Estadual de Ponta Grossa

aloguercio@hotmail.com+55 42 9902-9903

Outcome results

None listed

Source: REBEC (via WHO ICTRP)