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Influence of the Number of Layers of a One Bottle Adhesive on the Longevity of Composite Restorations in Primary Molars

Influence of the Number of Layers of a One Bottle Adhesive on the Longevity of Composite Resin Restorations in Primary Molars - Randomized Controlled Clinical Study.

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01680289
Enrollment
60
Registered
2012-09-07
Start date
2012-08-31
Completion date
2015-08-31
Last updated
2014-12-02

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

Conditions

Dental Caries, Secondary Dental Caries

Keywords

Dentin bonding agents, Composite restorations, Dental restoration failure

Brief summary

The aim of this study is to determinate the influence of an alternative adhesive application protocol (i.e. consecutive application of an extra adhesive layer)on restoration longevity in primary molars.

Detailed description

Adhesive systems based on total etch technique remains the most popular products among dental practitioners. These systems are based on the use of an acid conditioner to remove the smear layer and demineralize the enamel and dentin. After the removal of the conditioner by rinsing, a mixture containing the primer and adhesive - i.e. one bottle adhesives - is applicated over the demineralized tissues. The polymerization of the adhesive monomers into microporosities created by acid conditioning forms the structure knowing as hybrid layer or resin-dentin interdifusion zone. A common problem related to total etch technique is the incomplete infiltration of adhesive monomers through demineralized dentin, resulting in the presence of a zone of unprotected collagen fibrils beneath the hybrid layer that is prone to enzymatic degradation. According to some laboratory studies, consecutive application of multiple adhesive coats results in quantitative and qualitative improvements in dental adhesion. In addition to increasing the values of bond strength to dentin, consecutive application of multiple adhesive layers enhances the infiltration of adehesive monomers through demineralized dentin, resulting in a more homogenous hybrid layer.

Interventions

PROCEDUREThree adhesive coats

After caries removal, enamel margins will be conditioned with phosphoric acid gel 37% by 15 seconds and dentin walls by 8 seconds. The etchant will be removed with use of water spray by 30 seconds. The water excess will be removed with a cotton pellet. The first layer of Prime & Bond 2.1 adhesive will be applied with a microbrush. After 20 seconds a second layer will be applied and after a similar period a third layer will be applied over cavity walls. Again, after 20 seconds, the layers will be gently air-dried and photopolymerized by 10 seconds with a LED photoactivation unit.

PROCEDURETwo adhesive coats

After caries removal, enamel margins will be conditioned with phosphoric acid gel 37% by 15 seconds and dentin walls by 8 seconds. The etchant will be removed with use of water spray by 30 seconds. The water excess will be removed with a cotton pellet. The first layer of Prime & Bond 2.1 adhesive will be applied with a microbrush. After 20 seconds a second layer will be applied and after 20 seconds, the layers will be gently air-dried by 5 seconds. The two layers will be photopolymerized by 10 seconds with a LED photoactivation unit.

Sponsors

Universidade Federal do Rio de Janeiro
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
5 Years to 8 Years
Healthy volunteers
Yes

Inclusion criteria

* Presence of two or more pairs of caries lesions in occlusal or occluso-approximal surfaces of primary molars

Exclusion criteria

* Systemic diseases in which dental treatment is a risk to patient's life * Bruxism * Orthodontic appliance * Absence of occlusal contact in eligible teeth * Signs and symptoms of pulp infflamation or necrosis

Design outcomes

Primary

MeasureTime frameDescription
Survival rate06, 12, 18, 24, 30 and 36 monthsSurvival rate considering failure of restorations due: partial or complete loss of restorative material; marginal ditching; superficial or marginal discoloration; secondary caries; pulpal complications; wear of restorative material; tooth fracture.

Secondary

MeasureTime frameDescription
Marginal adaptation06, 12, 18, 24, 30 and 36 monthsEvaluation of resin replicas of restored teeth on scanning electron microscopy (SEM)

Countries

Brazil

Contacts

Primary ContactMarlus R Cajazeira, MsC
marlus.cajazeira@gmail.com55-21-8383-2492
Backup ContactLucianne Cople Maia, PhD
rorefa@gmail.com55-9994-3131

Outcome results

None listed

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