Glass Hybrid Versus Composite Restorations of Non-carious Cervical Lesions

NCT02631161 | Completed

• 1 other identifier: GHyComp
• Study Type: interventional
• Target: 88
• Locations: 1 country
• Sites: 1

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.

Conditions

Dental Cervical Non-carious Lesion

Outcome Measures

Primary Outcomes (1)

• Number of restorations with a re-intervention per all restorations

  Number of all restorations with a re-intervention being required per all placed restorations (events/sample)

  36 months

Secondary Outcomes (2)

• Restoration score

  36 months

• Costs for initial and retreatment

  recorded initially and, if required, each re-treatment appointment, over the total trial period (i.e. expected 36 months)

Study Arms (2)

EQUIA forte

EXPERIMENTAL

Dental non-carious cervical restorations are being restored with a glass hybrid restorative system (Medical product: EQUIA forte).

Other: Equia Forte

Filtek Supreme XT/Clearfil SE Bond

ACTIVE COMPARATOR

Dental non-carious cervical restorations are being restored with a composite resin based material/Adhesive combination (Medical product: Filtek Supreme XT/Clearfil SE Bond).

Other: Filtek Supreme XT/Clearfil SE Bond

Interventions

Equia Forte OTHER

Restoration of cavities with a Glasshybrid material (Equia Forte)

EQUIA forte

Filtek Supreme XT/Clearfil SE Bond OTHER

Restoration of cavities with a composite resin based material after placing an adhesive

Filtek Supreme XT/Clearfil SE Bond

Eligibility Criteria

• Age: 50 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Charite University, Berlin, Germany: lead
• GC Europe: collaborator

Study Sites (1)

Charité Centrum für Zahn-, Mund- und Kieferheilkunde, Abteilung für Zahnerhaltungskunde und Präventivzahnmedizin

Berlin, 14197, Germany

Location

Related Publications (2)

• 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.

  PMID: 34817964 DERIVED

• 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.

  PMID: 33979577 DERIVED

Study Officials

• Sebastian Paris, Prof. Dr.

  Abteilung für Zahnerhaltung und Präventivzahnmedizin, Charité Berlin

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PD Dr.

Study Record Dates

• First Submitted: December 7, 2015
• First Posted: December 16, 2015
• Study Start: December 1, 2015
• Primary Completion: February 1, 2021
• Study Completion: February 1, 2021
• Last Updated: June 18, 2021

Record last verified: 2021-06

Locations

DE (1)