Hybrid Ceramic on Worn Dentition Patients

Dental Wear Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04775823
• Other study ID #: 201912143RIPB
• Status: Recruiting
• Phase: N/A
• Start date: March 2, 2021
• Est. completion date: December 31, 2023

Study information

• Verified date: March 2021
• Source: National Taiwan University Hospital
• Contact: Yang Tsung-Chieh, PhD
• Phone: +886972652366
• Email: yangtc[@]ntuh.gov.tw
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: December 31, 2023
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 100 Years

Eligibility

1. Tooth erosion/attrition/abrasion/abfraction patients

2. Age above 20 years old

3. Return at certain period during the trial

4. Full understanding of written and spoken language

5. Agree with the questionnaire

Related Conditions & MeSH terms

• Dental Wear
• Tooth Wear

Intervention

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

Locations

Country	Name	City	State
Taiwan	National Taiwan University Hospital	Taipei	Test2

Sponsors (2)

Lead Sponsor	Collaborator
National Taiwan University Hospital	Taipei Medical University Hospital

Country where clinical trial is conducted

Taiwan, 

References & Publications (2)

Hickel R, Peschke A, Tyas M, Mjör 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 — View Citation

Hickel R, Roulet JF, Bayne S, Heintze SD, Mjör 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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	3months, 6months, 12months, 24months, 36months