Clinical trial NCT02631161: Glass Hybrid Versus Composite Restorations of Non-carious Cervical Lesions
Official title: Randomized Controlled Trial on Glass Hybrid Versus Composite Restorations of Non-carious Cervical Lesions
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dental Cervical Non-carious Lesion
Lead sponsor: Charite University, Berlin, Germany
Sponsor class: OTHER
Collaborators: name: GC Europe
First posted: 2015-12-16
Enrollment: 88
Sex: ALL
Minimum age (years): 50
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: A glass hybrid restorative system (EQUIA forte) clinically compared to a composite resin based material (Clearfil SE Bond, Filtek Supreme XT) for the treatment of dental non-carious cervical lesions.

Detailed description: This is a prospective, randomized, monocenter parallel group study on restoration of tooth with non-carious cervical restorations. Each patient receives cervical restoration(s) either with glass hybrid EQUIA forte or with composite resin/adhesive combination Filtek Supreme XT/Clearfil SE Bond in anterior/posterior tooth region. Restorations will be provided by one experienced operator. One of two independent examiners will evaluate the restorations at baseline (1 week after placement), and after 18, and 36 months according to the FDI criteria. Reliability of examination will be assessed on a random sample of 30 restorations.

Eligibility criteria: Inclusion Criteria:

* indication of a restorative treatment for a sclerotic non-carious cervical lesion
* lesions should be accessible for treatment and visual-tactile re-evaluation
* sufficient moisture control should be possible
* cervical margins should be located in dentin whereas the coronal margin should be located in enamel

Exclusion Criteria:

* allergy/hypersensitivity against any of the used materials
* participants should not be systematically ill, disabled, pregnant or participating in another study

Primary outcomes:
measure: Number of restorations with a re-intervention per all restorations
timeFrame: 36 months
Secondary outcomes:
measure: Restoration score
timeFrame: 36 months
measure: Costs for initial and retreatment
timeFrame: recorded initially and, if required, each re-treatment appointment, over the total trial period (i.e. expected 36 months)
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Charité Centrum für Zahn-, Mund- und Kieferheilkunde, Abteilung für Zahnerhaltungskunde und Präventivzahnmedizin
Study officials:
affiliation: Abteilung für Zahnerhaltung und Präventivzahnmedizin, Charité Berlin
name: Sebastian Paris, Prof. Dr.
role: STUDY_DIRECTOR
References:
citation: Gostemeyer G, Seifert T, Jeggle-Engbert LM, Paris S, Schwendicke F. Glass Hybrid Versus Nanocomposite for Restoration of Sclerotic Non-carious Cervical Lesions: 18-Month Results of a Randomized Controlled Trial. J Adhes Dent. 2021 Dec 3;23(6):487-496. doi: 10.3290/j.jad.b2287831.
citation: Schwendicke F, Muller A, Seifert T, Jeggle-Engbert LM, Paris S, Gostemeyer G. Glass hybrid versus composite for non-carious cervical lesions: Survival, restoration quality and costs in randomized controlled trial after 3 years. J Dent. 2021 Jul;110:103689. doi: 10.1016/j.jdent.2021.103689. Epub 2021 May 9.