BruxismNCT03713827

Clinical Performance of a Glass Hybrid Restorative in NCCL's of Patients With Bruxism

A study testing tooth restoration in people with Bruxism and Noncarious Cervical Lesions, run by Hacettepe University.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Trial summary

This is a double blinded, split mouth, randomized clinical study that evaluated the performance of a glass hybrid restorative material in non-carious servical lesions in patients with bruxism. The lesions were restored with glass hybrid restorative (Equia Forte) or nano ceramic composite resin (Ceram-x One). Read more about this study

Who is it for?: Ages 42 to 72 yearsHealthy volunteers can take part
Conditions the study is for: Bruxism, Noncarious Cervical Lesions
What is being tested?: tooth restoration
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 25 participants
Where: No sites listed yet
Study dates: Mar 2016to May 2022
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 42 to 72 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

non-hospitalized, healthy patients that were seeking dental treatmen
occlusally contacted teeth

Who cannot join

Patients having intensive medical history
Chronic periodontitis,
high caries activity,
extremely poor oral hygiene,
teeth with restorations,
mobility due to periodontal disease
in contacted with removable prosthetic construction were excluded from the study

About this study

Official title: 24-Month Performance of a Glass-hybrid-restorative in Non-carious Cervical Lesions of Patients With Bruxism: A Split-mouth, Randomized Clinical Trial

Read the detailed description

The aim of this study was to evaluate the clinical performance of a glass-hybrid-restorative compared with a nano ceramic composite resin in non-carious cervical lesions (NCCLs) of patients with bruxism.

For this purpose, twenty-five patients having NCCLs and bruxism enrolled to the present study. Before treatment, the dimensions of the NCCLs were measured in depth, gingival-incisal height and mesio-distal width using a CPI probe. Degree of tooth wear (TWI) and gingival conditions (GI) are also recorded. A total of 148 NCCLs were randomly restored with a a glass-hybrid-restorative system (Equia Forte Fil, GC, Tokyo, Japan) or a nano ceramic composite resin (Ceram.X One Universal, Dentsply, DeTrey, Konstanz, Germany) and restorations were evaluated at baseline and after 6,12 and 24 months according to the modified-USPHS criteria. Data were analyzed with Chi- Square, Fisher's Exact Test, Mann Whitney-U and Cochran's Q tests (p < 0.05).

Conditions: Bruxism, Noncarious Cervical Lesions
Being tested: tooth restoration
Keywords: glass hybrids, bruxism, Non carious cervical lesions
Medical subject headings: Bruxism

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

tooth restorationDevice
restoration of non carious cervical lesions with two different restorative materials

Study groups in NCT03713827
Study group	Role	What they receive
"composite resin", "Ceram-x One Universal"	Active comparator	tooth restoration with nano-ceramic composite resin "Ceram-x one Universal" Receives: Device: tooth restoration
"glass ionomer cement", "Equia Forte"	Active comparator	Tooth restoration with glass ionomer cement (Glass hybrid restorative system) "Equia Forte" Receives: Device: tooth restoration

What is being measured

The primary outcome is the main question the study is designed to answer.

Retention Alpha for at least 90% of the restorations
The primary factor for determining the clinical performance of a restorative material is the retention rate. It represents the survival rates of the restorations after a period of time. According to ADA guidelines, a restorative material should show at leat 90% alpha retention rate after 18 months to be considered as clinically acceptable. The retention is assesed as alpha (retentive restoratation) or charlie (failed restoration). Clinical evaluation is performed to examine if the restoration is in place or has fallen.
Measured: 24 months

Secondary outcomes (1)

marginal adaptation score alpha
It represents the marginal integrity of the restorations. It is scored as alpha (perfect marginal adaptation), bravo (detectable marginal discrepency, clinically acceptable) or charlie (marginal crevice, clinically unacceptable). The examination of marginal adaptation is performed by clinical examination of the restoration with probe.
Measured: 24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Mar 2016May 2022

First posted22 Oct 2018
Study startMar 2016
Primary completionJun 2018
Study completionMay 2022 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for BruxismStudies of the same condition, open and under way.
More trials run by Hacettepe UniversityThe 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: Factorial
Model description: double blinded, split mouth, randomized clinical trial
Masking: None (open label)
Enrolment: 25 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03713827
Sponsor's protocol ID: KA-16020
Status last verified: Oct 2018
First submitted: 15 Oct 2018
Last updated: 22 Oct 2018
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: Yes
Individual data sharing: Undecided

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

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All Bruxism trials

Study at a glance

From the registry record, last updated by the sponsor on 22 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: 24-Month Performance of a Glass-hybrid-restorative in Non-carious Cervical Lesions of Patients With Bruxism: A Split-mouth, Randomized Clinical Trial
ClinicalTrials.gov ID: NCT03713827
Acronym / sponsor ID: KA-16020
Conditions: Bruxism, Noncarious Cervical Lesions
Keywords: glass hybrids, bruxism, Non carious cervical lesions
Study type: Interventional
Recruitment status: Unknown status
Enrolment: 25 participants (actual)
Lead sponsor: Hacettepe UniversityUniversity, hospital or other
Study start: Mar 2016 (actual)
Primary completion: Jun 2018 (actual)
Study completion: May 2022 (estimated)
First posted: 22 Oct 2018 (actual)
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.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Factorial
Masking: None (open label)
Number of arms: 2
Model description: double blinded, split mouth, randomized clinical trial

Arm	Type	Receives
"composite resin", "Ceram-x One Universal"	Active comparator	Device: tooth restorationtooth restoration with nano-ceramic composite resin "Ceram-x one Universal"
"glass ionomer cement", "Equia Forte"	Active comparator	Device: tooth restorationTooth restoration with glass ionomer cement (Glass hybrid restorative system) "Equia Forte"

Who may qualify

Ages: 42 to 72 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (2 listed)

non-hospitalized, healthy patients that were seeking dental treatmen
occlusally contacted teeth

Key exclusion criteria (7 listed)

Patients having intensive medical history
Chronic periodontitis,
high caries activity,
extremely poor oral hygiene,
teeth with restorations,

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
tooth restorationrestoration of non carious cervical lesions with two different restorative materials	Device	"composite resin", "Ceram-x One Universal", "glass ionomer cement", "Equia Forte"

Primary outcome

Retention Alpha for at least 90% of the restorations
Time frame: 24 months
The primary factor for determining the clinical performance of a restorative material is the retention rate. It represents the survival rates of the restorations after a period of time. According to ADA guidelines, a restorative material should show at leat 90% alpha retention rate after 18 months to be considered as clinically acceptable. The retention is assesed as alpha (retentive restoratation) or charlie (failed restoration). Clinical evaluation is performed to examine if the restoration is in place or has fallen.

1 secondary outcome

marginal adaptation score alpha
Time frame: 24 months

Results and safety

Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 2018.
Individual participant dataSharing planned: Undecided

Related trials for Bruxism

RecruitingObservational study
Bruxism, Anxiety, and Periodontal Status Among Dental Students
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RecruitingObservational study
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Enrolling by invitationObservational study
The General Aim is to Implement Clinical Assessment of Overload by Voluntary Bite Force Registration to Enable Future Simple But Precise Risk Assessment to Provide Individualized Treatment Plans.
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RecruitingObservational study
Effect Of Orofacial Pain Therapy On Bruxism
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Not yet recruiting
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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.

The record lists no contact. Use the official record to reach the sponsor.

Questions about this trial

What is this clinical trial studying?

A study testing tooth restoration in people with Bruxism and Noncarious Cervical Lesions, run by Hacettepe University.

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 2 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 22 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.

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?

Results are not available in the source record.

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?

Retention Alpha for at least 90% of the restorations (time frame: 24 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 NCT03713827.

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 22 Oct 2018.