Clinical Trials Directory

Trials / Completed

CompletedNCT03993431

Influence of Luting Cement on the Clinical Outcomes of Zirconia Pediatric Crowns

Influence of Luting Cement on the Clinical Outcomes of Zirconia Pediatric Crowns. A 3 Year Split-Mouth Randomized Controlled Trial

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
25 (actual)
Sponsor
Fayoum University · Academic / Other
Sex
All
Age
4 Years – 7 Years
Healthy volunteers
Accepted

Summary

The purpose of this split-mouth study was to compare the efficacy of using Bio-active cement versus Packable glass ionomer for cementation of posterior zirconia pediatric crowns.

Detailed description

Restoration of pulp treated or badly broken down deciduous teeth with full coverage restoration have shown superior success rate to all other restorative materials. Restoration of deciduous teeth with esthetic full coverage restoration has been a challenging aim especially for the more functionally loaded posterior teeth. Due to the continuous increase in socio-economic standards; restoring posterior teeth with esthetic restoration is on high demand nowadays. The recently introduced zirconia pediatric crowns have been very promising in terms of strength and toughness. Clinical trials on maxillary incisors have shown very high success rates in terms of retention and gingival health. The problem of restoring posterior deciduous teeth with pre-fabricated zirconia crowns is that its retention is only and totally dependent on luting cement, in addition to the problem of the deteriorated gingival condition around crowns in general. Being recently introduced to the market; there have not been any clinical trials studying retention of zirconia posterior pediatric crowns published yet. Recently introduced bio-active cement \[NuSmile® BioCem™\] is claimed by the manufacturer to be the solution of this problem due to the shock absorbing effect, bioactive components, and antimicrobial effect making it tougher than traditional cements and more gingival friendly. Also, experienced clinicians have found that packable glass ionomer gives very acceptable results for retention of zirconia pediatric crowns. This may be due to the fact that, pre-fabricated pediatric crown is not well adapted to the prepared tooth creating a greater gap between the prepared tooth and the crown, resulting in a greater film thickness of luting cement, which may benefit from the stronger, tougher and less soluble packable glass ionomer rather than the conventional glass ionomer cement for cementation of zirconia crowns. There is no clear evidence whether it's better to cement zirconia based crowns with conventional or adhesive cement; and to the investigator's knowledge, there is no data available for the best clinical practice in cementation of zirconia pediatric crowns; and so, this study was carried out to compare the effectiveness of bio-active cement with packable glass ionomer when used for cementation of zirconia pediatric crowns.

Conditions

Interventions

TypeNameDescription
DRUGBio-active cementA cement used for crown cementation, specially recommended for pediatric esthetic crowns
DRUGPackable glass ionomerGlass ionomer cement with improved mechanical properties usually used for restoration of simple small cavities and in Atraumatic Restorative Treatment

Timeline

Start date
2015-07-01
Primary completion
2018-12-01
Completion
2018-12-01
First posted
2019-06-20
Last updated
2019-06-20

Source: ClinicalTrials.gov record NCT03993431. Inclusion in this directory is not an endorsement.