Dental Cervical Non-carious LesionNCT02631161
Glass Hybrid Versus Composite Restorations of Non-carious Cervical Lesions
A study testing Equia Forte and Filtek Supreme XT/Clearfil SE Bond in people with Dental Cervical Non-carious Lesion, run by Charite University, Berlin, Germany at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Dental Cervical Non-carious Lesion
- What is being tested?
- Equia Forte and Filtek Supreme XT/Clearfil SE Bond
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 88 participants
- Where
- 1 siteGermany
- Study dates
- Dec 2015to 1 Feb 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- allergy/hypersensitivity against any of the used materials
- participants should not be systematically ill, disabled, pregnant or participating in another study
Trial locations and contacts
1 site in 1 country.
Germany1 site
Charité Centrum für Zahn-, Mund- und Kieferheilkunde, Abteilung für Zahnerhaltungskunde und Präventivzahnmedizin
Berlin, 14197
About this study
Official title: Randomized Controlled Trial on Glass Hybrid Versus Composite Restorations of Non-carious Cervical Lesions
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.
Read the 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.
- Conditions
- Dental Cervical Non-carious Lesion
- Being tested
- Equia Forte, Filtek Supreme XT/Clearfil SE Bond
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Equia ForteOther
Restoration of cavities with a Glasshybrid material (Equia Forte)
Filtek Supreme XT/Clearfil SE BondOther
Restoration of cavities with a composite resin based material after placing an adhesive
| Study group | Role | What they receive |
|---|---|---|
| EQUIA forte | Experimental | Dental non-carious cervical restorations are being restored with a glass hybrid restorative system (Medical product: EQUIA forte). Receives: 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). Receives: Other: Filtek Supreme XT/Clearfil SE Bond |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 36 months
Secondary outcomes (2)
Restoration score
score according to FDI criteria
Measured: 36 months
Costs for initial and retreatment
Costs incurred for staff and material for initial and re-treatments
Measured: recorded initially and, if required, each re-treatment appointment, over the total trial period (i.e. expected 36 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2015 (estimated)
- Study startDec 2015
- Primary completion1 Feb 2021
- Study completion1 Feb 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Dental Cervical Non-carious LesionStudies of the same condition, open and under way.
- More trials run by Charite University, Berlin, GermanyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 88 participants (actual)
Sponsor and investigators
- Lead sponsor
- Charite University, Berlin, Germany
- Sponsor type
- University, hospital or other
- Collaborators
- GC Europe
- Responsible party
- Principal investigator, Falk Schwendicke, Charite University, Berlin, Germany
- Investigators
- Sebastian Paris, Prof. Dr., Study director, Abteilung für Zahnerhaltung und Präventivzahnmedizin, Charité Berlin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02631161
- Sponsor's protocol ID
- GHyComp
- Status last verified
- Jun 2021
- First submitted
- 7 Dec 2015
- Last updated
- 18 Jun 2021
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 34817964Schwendicke 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.
PubMed 33979577
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Trial on Glass Hybrid Versus Composite Restorations of Non-carious Cervical Lesions
- ClinicalTrials.gov ID
- NCT02631161
- Acronym / sponsor ID
- GHyComp
- Conditions
- Dental Cervical Non-carious Lesion
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 88 participants (actual)
- Lead sponsor
- Charite University, Berlin, GermanyUniversity, hospital or other
- Collaborators
- GC Europe
- Study start
- Dec 2015 (actual)
- Primary completion
- 1 Feb 2021 (actual)
- Study completion
- 1 Feb 2021 (actual)
- First posted
- 16 Dec 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| EQUIA forte | Experimental | Other: Equia ForteDental non-carious cervical restorations are being restored with a glass hybrid restorative system (Medical product: EQUIA forte). |
| Filtek Supreme XT/Clearfil SE Bond | Active comparator | Other: Filtek Supreme XT/Clearfil SE BondDental non-carious cervical restorations are being restored with a composite resin based material/Adhesive combination (Medical product: Filtek Supreme XT/Clearfil SE Bond). |
Who may qualify
- Ages
- 50 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- allergy/hypersensitivity against any of the used materials
- participants should not be systematically ill, disabled, pregnant or participating in another study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Equia ForteRestoration of cavities with a Glasshybrid material (Equia Forte) | Other | EQUIA forte |
| Filtek Supreme XT/Clearfil SE BondRestoration of cavities with a composite resin based material after placing an adhesive | Other | Filtek Supreme XT/Clearfil SE Bond |
Primary outcome
Number of restorations with a re-intervention per all restorations
Time frame: 36 months
Number of all restorations with a re-intervention being required per all placed restorations (events/sample)
2 secondary outcomes
Restoration score
Time frame: 36 months
Costs for initial and retreatment
Time frame: recorded initially and, if required, each re-treatment appointment, over the total trial period (i.e. expected 36 months)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2021.
- Derived from this study: PubMed 34817964Gostemeyer 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.
- Derived from this study: PubMed 33979577Schwendicke 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sebastian Paris, Prof. Dr. study director
Abteilung für Zahnerhaltung und Präventivzahnmedizin, Charité Berlin
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Equia Forte and Filtek Supreme XT/Clearfil SE Bond in people with Dental Cervical Non-carious Lesion, run by Charite University, Berlin, Germany at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of restorations with a re-intervention per all restorations (time frame: 36 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02631161, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jun 2021.