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Clinical evaluation of restorations using an Universal Adhesive and a surface treatment

Evaluation of the longevity of direct restorations of non-carious Cervical Lesions using a Universal Adhesive and surface pretreatment. Randomized clinical trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
REBEC
Registry ID
RBR-86t94mn
Enrollment
Unknown
Registered
2024-03-30
Start date
2022-09-25
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 Erosion

Interventions

The present work will be a clinical, randomized, double-blind (to the research participant and the researcher who evaluated the restoration), split-mouth study, carried out at the Special Laboratory o

Sponsors

Faculdade de Odontologia da Universidade de São Paulo
Lead Sponsor
Faculdade de Odontologia da Universidade de São Paulo
Collaborator

Eligibility

Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: Volunteers at least 18 years of age; both genders; in good general health; with at least 4 teeth (premolars or molars) with non-carious cervical lesions with a depth and extension of at least 1 mm, vital and without mobility; with at least 20 teeth in occlusion

Exclusion criteria

Exclusion criteria: Volunteers with medical conditions that may interfere with the volunteer's health, such as allergic reactions to substances or products that will be used; use of a removable prosthesis with a clip on the tooth that will be used in the research; active caries lesions and/or defective restorations in the tooth to be analyzed and/or with periodontal disease; severe bruxism; professional desensitizing treatment in the last 6 months on the tooth that will be used in the research; research participants who are pregnant or breastfeeding; research participants undergoing orthodontic treatment

Design outcomes

Primary

MeasureTime frame
It is expected to find differences between the restoration retention parameter. To assess retention, the FDI (World Dental Federation) criteria will be used, where restorations will be classified into scores from 1 to 5, with criterion 1 being restorations without loss of retention; 2 with small crack line; 3 with two or more lines of cracks and/or small chips or fracture of the material without affecting the marginal integrity; 4 with partial loss of material (less than half of the restoration); 5 with partial or complete loss of restoration

Secondary

MeasureTime frame
It is expected to find differences between the staining parameter of the restoration. To evaluate, the FDI (World Dental Federation) criteria will be used, where restorations will be classified into scores from 1 to 5, with criterion 1 being for restorations without staining; 2 with small staining; 3 with moderate staining; 4 unacceptable staining; 5 Severe staining;It is expected to find differences between the marginal adaptation parameter of the restoration. To assess, the FDI (World Dental Federation) criteria will be used, where restorations will be classified into scores from 1 to 5, with criterion 1 being for harmonious restorations without cracks; 2 with white lines; 3 with cracks and small fractures; 4 major irregularities; 5 larger cracks or generalized irregularities;It is expected to find differences between the postoperative sensitivity parameter of the restoration. For evaluation, the FDI (World Dental Federation) criteria will be used, where restorations will be classified into scores from 1 to 5, with criterion 1 being for restorations without sensitivity; 2 with low sensitivity for a short time; 3 with more intense sensitivity; 4 very intense; 5 acute pulpitis;It is expected to find differences between the lesion recurrence parameter. For evaluation, the FDI (World Dental Federation) criteria will be used, where restorations will be classified into scores from 1 to 5, with criterion 1 being for restorations without recurrence; 2 with small, localized lesion; 3 with larger areas of demineralization; 4 dentin erosion; 5 exposure of dentin that requires replacement of the restoration

Countries

Brazil

Contacts

Public ContactAna Cecilia Aranha

Faculdade de Odontologia da Universidade de São Paulo

acca@usp.br+55(11)30917645

Outcome results

None listed

Source: REBEC (via WHO ICTRP)