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Hybrid Ceramic on Worn Dentition Patients

Primary Purpose

Dental Wear

Status
Recruiting
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Hybrid composite nano-ceramic
Sponsored by
National Taiwan University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dental Wear focused on measuring Dentistry

Eligibility Criteria

20 Years - 100 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers
  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

Sites / Locations

  • National Taiwan University HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Hybrid composite nano-ceramic

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
February 16, 2021
Last Updated
March 2, 2021
Sponsor
National Taiwan University Hospital
Collaborators
Taipei Medical University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04775823
Brief Title
Hybrid Ceramic on Worn Dentition Patients
Official Title
Evaluation of Hybrid Composite-nanoceramic on Material Characteristic and Clinical Use Over Tooth Wear Patients.
Study Type
Interventional

2. Study Status

Record Verification Date
March 2021
Overall Recruitment Status
Recruiting
Study Start Date
March 2, 2021 (Anticipated)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Taiwan University Hospital
Collaborators
Taipei Medical University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dental Wear
Keywords
Dentistry

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Hybrid composite nano-ceramic
Arm Type
Experimental
Intervention Type
Procedure
Intervention Name(s)
Hybrid composite nano-ceramic
Intervention Description
Indirect bonding the hybrid composite nano-ceramic restoration to the tooth to be restored of worn dentition patients
Primary Outcome Measure Information:
Title
Evaluation the change of hybrid composite-nanoceramic on material characteristic and clinical use over tooth wear patients.
Description
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.
Time Frame
3months, 6months, 12months, 24months, 36months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yang Tsung-Chieh, PhD
Phone
+886972652366
Email
yangtc@ntuh.gov.tw
First Name & Middle Initial & Last Name or Official Title & Degree
Shen Chun-Min, DDS
Phone
+886933694030
Email
jeremyxchaos@hotmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yang Tsung-Chieh, PhD
Organizational Affiliation
Associate Professor
Official's Role
Principal Investigator
Facility Information:
Facility Name
National Taiwan University Hospital
City
Taipei
State/Province
Test2
ZIP/Postal Code
100225
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yang Tsung-Chieh
Phone
+886972652366
Email
yangtc@ntuh.gov.tw

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
20847997
Citation
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.
Results Reference
result
PubMed Identifier
18341239
Citation
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.
Results Reference
result

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Hybrid Ceramic on Worn Dentition Patients

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