Hybrid Ceramic on Worn Dentition Patients

Sponsor

National Taiwan University Hospital (Other)

Overall Status

Recruiting

CT.gov ID

NCT04775823

Collaborator

Taipei Medical University Hospital (Other)

Enrollment

Location

Arm

Anticipated Duration (Months)

1.5

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Evaluation of hybrid composite-nanoceramic on material characteristic and clinical use over tooth wear patients.

Condition or Disease	Intervention/Treatment	Phase
Dental Wear	Procedure: Hybrid composite nano-ceramic	N/A

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

Study Type:

Interventional

Anticipated Enrollment :

50 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Evaluation of Hybrid Composite-nanoceramic on Material Characteristic and Clinical Use Over Tooth Wear Patients.

Anticipated Study Start Date :

Mar 2, 2021

Anticipated Primary Completion Date :

Dec 31, 2023

Anticipated Study Completion Date :

Dec 31, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Hybrid composite nano-ceramic	Procedure: Hybrid composite nano-ceramic Indirect bonding the hybrid composite nano-ceramic restoration to the tooth to be restored of worn dentition patients

Arm

Intervention/Treatment

Experimental: Hybrid composite nano-ceramic

Procedure: Hybrid composite nano-ceramic

Indirect bonding the hybrid composite nano-ceramic restoration to the tooth to be restored of worn dentition patients

Outcome Measures

Primary Outcome Measures

Evaluation the change of hybrid composite-nanoceramic on material characteristic and clinical use over tooth wear patients. [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 100 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	National Taiwan University Hospital	Taipei	Test2	Taiwan	100225

Sponsors and Collaborators

National Taiwan University Hospital
Taipei Medical University Hospital

Investigators

Principal Investigator: Yang Tsung-Chieh, PhD, Associate Professor

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

National Taiwan University Hospital

ClinicalTrials.gov Identifier:

NCT04775823

Other Study ID Numbers:

201912143RIPB

First Posted:

Mar 1, 2021

Last Update Posted:

Mar 4, 2021

Last Verified:

Mar 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by National Taiwan University Hospital

Dentistry

Additional relevant MeSH terms:

Tooth Wear

Study Results

No Results Posted as of Mar 4, 2021