Hybrid Ceramic on Worn Dentition Patients

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.

Study Overview

• Status: Recruiting
• Conditions: Dental Wear
• Intervention / Treatment: Procedure: Hybrid composite nano-ceramic

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 Type: Interventional
• Enrollment (Anticipated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Yang Tsung-Chieh, PhD; Phone Number: +886972652366; Email: yangtc@ntuh.gov.tw
• Study Contact Backup: Name: Shen Chun-Min, DDS; Phone Number: +886933694030; Email: jeremyxchaos@hotmail.com

Study Locations

• Taiwan
  • Test2
    • Taipei, Test2, Taiwan, 100225
      • Recruiting
      • National Taiwan University Hospital
      • Contact: Yang Tsung-Chieh; Phone Number: +886972652366; Email: yangtc@ntuh.gov.tw

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 100 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: National Taiwan University Hospital
• Collaborators: Taipei Medical University Hospital
• Investigators: Principal Investigator: Yang Tsung-Chieh, PhD, Associate Professor

Publications and helpful links

General 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.
• Hickel 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. Erratum In: J Adhes Dent. 2007 Dec;9(6):546.

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): March 2, 2021
• Primary Completion (ANTICIPATED): December 31, 2023
• Study Completion (ANTICIPATED): December 31, 2023

Study Registration Dates

• First Submitted: February 16, 2021
• First Submitted That Met QC Criteria: February 25, 2021
• First Posted (ACTUAL): March 1, 2021

Study Record Updates

• Last Update Posted (ACTUAL): March 4, 2021
• Last Update Submitted That Met QC Criteria: March 2, 2021
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Keywords: Dentistry
• Additional Relevant MeSH Terms: Stomatognathic Diseases; Tooth Diseases; Tooth Wear
• Other Study ID Numbers: 201912143RIPB

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No