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Clinical Trial of the Effect of Different Categories of Adhesive System

Randomized Clinical Trial of the Effect of Different Categories of Adhesive System

Status
UNKNOWN
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02751970
Enrollment
185
Registered
2016-04-26
Start date
2014-04-30
Completion date
2018-04-30
Last updated
2016-04-26

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

Conditions

Dental Caries

Keywords

Dental adhesive, adhesive systems, Dental Restoration Failure

Brief summary

This study aims to evaluate the clinical effectiveness of contemporary resin-based adhesive systems by retention rate of resin restorations placed in non carious cervical lesions with four different adhesive strategies: 3 and 2 steps etch-and-rinse adhesive system, 2 and 1 step self-etch adhesive systems.

Detailed description

The etch-and-rinse (3 and 2 steps) and self-etch (1 and 2 steps) adhesive systems allow the bond between the resins restorations with the dental substrates, but they have mechanism of action different. The success of resin composite restorations is reliant upon adhesion to the underlying tooth via adhesive systems. The mechanism of adhesion to enamel and dentine could be involved for one hand, the etching the substrates with 30-40% phosphoric acid, followed by the application of a primer and subsequently an adhesive resin 3 steps etch-and- rinse approach or 2 steps when to combine the primer and adhesive into one bottle. For another hand, the self- etch systems with acid monomers in their primer, allow conditioning the surface without phosphoric acid step. So, they consist of either a self-etching primer accompanied by an adhesive resin applied as a subsequent step (2 steps) or a self-etch adhesive, which does not require a separate primer (1 step).

Interventions

PROCEDUREDental restoration

Methacrylate resins will be used to complement the cavity restoration after of adhesive procedure

PROCEDURE3 step ER

Enamel and dentin will be conditioning with 35% phosphoric acid, then applied primer, and then applied adhesive resin.

PROCEDURE2 step ER

Enamel and dentin will be conditioning with 35% of phosphoric acid, then applied primer/adhesive resin.

PROCEDURE2 step SE

Enamel and dentin will be conditioning with acidic primer, then applied primer/adhesive resin.

PROCEDURE1 step SE

Enamel and dentin will be conditioning with acidic primer/adhesive resin.

Sponsors

Universidade Estadual de Ponta Grossa
CollaboratorOTHER
Universidad de Valparaiso
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

* Good general health, * Patients with acceptable oral hygiene level, * Patients with at least 20 teeth under occlusion. * Patients with at least four non-carious cervical lesions in four different teeth * Patients with maximum of eight lesions that needed to be restored. * These lesions had to be non-carious, non-retentive, deeper than 1 mm, and involve both the enamel and dentin of vital teeth without mobility.

Exclusion criteria

* Patients with extremely poor oral hygiene, * Patients with severe or chronic periodontitis, * Patients with heavy bruxism habits.

Design outcomes

Primary

MeasureTime frameDescription
Secondary cariesone yearSecondary caries near and/or associated of the dental restorations
Retention rateone yearretention rate of the dental restorations

Secondary

MeasureTime frameDescription
Marginal integrityone yearmarginal integrity of the dental restorations
Marginal discolorationone yearMarginal discoloration of the dental restorations
post-operative sensitivityone yeardentin post-operative sensitivity

Countries

Chile

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026