Dental WearNCT04775823
Hybrid Ceramic on Worn Dentition Patients
A study testing Hybrid composite nano-ceramic in people with Dental Wear, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
Evaluation of hybrid composite-nanoceramic on material characteristic and clinical use over tooth wear patients. Read more about this study
- Who is it for?
- Ages 20 to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- Dental Wear
- What is being tested?
- Hybrid composite nano-ceramic
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteTaiwan
- Study dates
- 2 Mar 2021to 31 Dec 2023
- 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 20 to 100 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
- Tooth erosion/attrition/abrasion/abfraction patients
- Age above 20 years old
- Return at certain period during the trial
- Full understanding of written and spoken language
- Agree with the questionnaire
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
National Taiwan University Hospital
Taipei, Test2, 100225
Yang Tsung-Chieh, +886972652366, yangtc@ntuh.gov.tw
About this study
Official title: Evaluation of Hybrid Composite-nanoceramic on Material Characteristic and Clinical Use Over Tooth Wear Patients.
Evaluation of hybrid composite-nanoceramic on material characteristic and clinical use over tooth wear patients.
Read the detailed description
Composite resin is often used to restore patient's dental defficiency, and also the material to cover and protect weak tooth structure. In tooth wear patients, multiple factors attributing to destruct their teeth. The durability and strength of the resotrative material must be reinforced. Nanoceramic infiltrated in composite resin may enhance its mechanical characteristics. Therefore, hybrid composite-nanoceramic material may be effective for tooth wear patients.
- Conditions
- Dental Wear
- Being tested
- Hybrid composite nano-ceramic
- Keywords
- Dentistry
- Medical subject headings
- Tooth Wear
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hybrid composite nano-ceramicProcedure or surgery
Indirect bonding the hybrid composite nano-ceramic restoration to the tooth to be restored of worn dentition patients
| Study group | Role | What they receive |
|---|---|---|
| Hybrid composite nano-ceramic | Experimental | Not described Receives: Procedure: Hybrid composite nano-ceramic |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation the change of hybrid composite-nanoceramic on material characteristic and clinical use over tooth wear patients.
Participants with worn dentition dentition (attrition, erosion, abrasion, abfraction) were enrolled in the present study. They were restored with hybrid composite-nanoceramic resin(Cerasmart, GC Corporation).
During the follow up time, participants were examined with clinical photos, radiographic film, intraoral scans, and asked to fill in questionnaires. The questionnaires included subjective questionnaire with VAS scale and objective questionnaire according to FDI criteria.
The restorations were evaluated by two observers at baseline and after 3, 6, 12, 24, 36 months according to the FDI criteria, which were categorized into three groups: esthetic parameters (four criteria), functional parameters (six criteria) and biological parameters (six criteria). Restorations were scored for clinical acceptability. Scores 4 and 5 were recorded as clinically unacceptable, and scores 5 was recorded for clinically failed.
Measured: 3months, 6months, 12months, 24months, 36months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2021
- Study start2 Mar 2021 (estimated)
- Primary completion31 Dec 2023 (estimated)
- Study completion31 Dec 2023 (estimated)
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 WearStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Taipei Medical University Hospital
- Responsible party
- Sponsor
- Investigators
- Yang Tsung-Chieh, PhD, Principal investigator, Associate Professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04775823
- Sponsor's protocol ID
- 201912143RIPB
- Status last verified
- Mar 2021
- First submitted
- 16 Feb 2021
- Last updated
- 4 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Hickel R, Peschke A, Tyas M, Mjor I, Bayne S, Peters M, Hiller KA, Randall R, Vanherle G, Heintze SD. FDI World Dental Federation - clinical criteria for the evaluation of direct and indirect restorations. Update and clinical examples. J Adhes Dent. 2010 Aug;12(4):259-72. doi: 10.3290/j.jad.a19262.
PubMed 20847997Hickel R, Roulet JF, Bayne S, Heintze SD, Mjor IA, Peters M, Rousson V, Randall R, Schmalz G, Tyas M, Vanherle G. Recommendations for conducting controlled clinical studies of dental restorative materials. Science Committee Project 2/98--FDI World Dental Federation study design (Part I) and criteria for evaluation (Part II) of direct and indirect restorations including onlays and partial crowns. J Adhes Dent. 2007;9 Suppl 1:121-47.
PubMed 18341239
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Hybrid Composite-nanoceramic on Material Characteristic and Clinical Use Over Tooth Wear Patients.
- ClinicalTrials.gov ID
- NCT04775823
- Acronym / sponsor ID
- 201912143RIPB
- Conditions
- Dental Wear
- Keywords
- Dentistry
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Collaborators
- Taipei Medical University Hospital
- Study start
- 2 Mar 2021 (estimated)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 1 Mar 2021 (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.
Evaluation of hybrid composite-nanoceramic on material characteristic and clinical use over tooth wear patients.
Detailed description
Composite resin is often used to restore patient's dental defficiency, and also the material to cover and protect weak tooth structure. In tooth wear patients, multiple factors attributing to destruct their teeth. The durability and strength of the resotrative material must be reinforced. Nanoceramic infiltrated in composite resin may enhance its mechanical characteristics. Therefore, hybrid composite-nanoceramic material may be effective for tooth wear patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Hybrid composite nano-ceramic | Experimental | Procedure: Hybrid composite nano-ceramic |
Who may qualify
- Ages
- 20 to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| Hybrid composite nano-ceramicIndirect bonding the hybrid composite nano-ceramic restoration to the tooth to be restored of worn dentition patients | Procedure or surgery | Hybrid composite nano-ceramic |
Primary outcome
Evaluation the change of hybrid composite-nanoceramic on material characteristic and clinical use over tooth wear patients.
Time frame: 3months, 6months, 12months, 24months, 36months
Participants with worn dentition dentition (attrition, erosion, abrasion, abfraction) were enrolled in the present study. They were restored with hybrid composite-nanoceramic resin(Cerasmart, GC Corporation). During the follow up time, participants were examined with clinical photos, radiographic film, intraoral scans, and asked to fill in questionnaires. The questionnaires included subjective questionnaire with VAS scale and objective questionnaire according to FDI criteria. The restorations were evaluated by two observers at baseline and after 3, 6, 12, 24, 36 months according to the FDI criteria, which were categorized into three groups: esthetic parameters (four criteria), functional parameters (six criteria) and biological parameters (six criteria). Restorations were scored for clinical acceptability. Scores 4 and 5 were recorded as clinically unacceptable, and scores 5 was recorded for clinically failed.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2021.
- Results publication: PubMed 20847997Hickel R, Peschke A, Tyas M, Mjor I, Bayne S, Peters M, Hiller KA, Randall R, Vanherle G, Heintze SD. FDI World Dental Federation - clinical criteria for the evaluation of direct and indirect restorations. Update and clinical examples. J Adhes Dent. 2010 Aug;12(4):259-72. doi: 10.3290/j.jad.a19262.
- Results publication: PubMed 18341239Hickel R, Roulet JF, Bayne S, Heintze SD, Mjor IA, Peters M, Rousson V, Randall R, Schmalz G, Tyas M, Vanherle G. Recommendations for conducting controlled clinical studies of dental restorative materials. Science Committee Project 2/98--FDI World Dental Federation study design (Part I) and criteria for evaluation (Part II) of direct and indirect restorations including onlays and partial crowns. J Adhes Dent. 2007;9 Suppl 1:121-47.
- Individual participant dataSharing planned: No
Related trials for Dental Wear
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Evaluation of Wear Resistance of CAD/CAM Hybrid Ceramic and Nano-Hybrid Composite Overlays in Endodontically Treated Molars and Their Effect on Natural Antagonist Teeth
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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.
Yang Tsung-Chieh, PhD principal investigator
Associate Professor
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hybrid composite nano-ceramic in people with Dental Wear, run by National Taiwan University Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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 4 Mar 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 Taiwan. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yang Tsung-Chieh, PhD (+886972652366, yangtc@ntuh.gov.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation the change of hybrid composite-nanoceramic on material characteristic and clinical use over tooth wear patients. (time frame: 3months, 6months, 12months, 24months, 36months). 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 NCT04775823, 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 4 Mar 2021.