NCT04775823

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2021

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 16, 2021

Completed
13 days until next milestone

First Posted

Study publicly available on registry

March 1, 2021

Completed
1 day until next milestone

Study Start

First participant enrolled

March 2, 2021

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2023

Completed
Last Updated

March 4, 2021

Status Verified

March 1, 2021

Enrollment Period

2.8 years

First QC Date

February 16, 2021

Last Update Submit

March 2, 2021

Conditions

Dental Wear

Keywords

Dentistry

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (1)

Hybrid composite nano-ceramic

EXPERIMENTAL
Procedure: Hybrid composite nano-ceramic

Interventions

Hybrid composite nano-ceramicPROCEDURE

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

Hybrid composite nano-ceramic

Eligibility Criteria

Age20 Years - 100 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

National Taiwan University Hospital

Taipei, Test2, 100225, Taiwan

RECRUITING

Related Publications (2)

  • 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.

    PMID: 20847997RESULT

  • 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.

    PMID: 18341239RESULT

MeSH Terms

Conditions

Tooth Wear

Condition Hierarchy (Ancestors)

Tooth DiseasesStomatognathic Diseases

Study Officials

  • Yang Tsung-Chieh, PhD

    Associate Professor

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Yang Tsung-Chieh, PhD

CONTACT

+886972652366yangtc@ntuh.gov.tw

Shen Chun-Min, DDS

CONTACT

+886933694030jeremyxchaos@hotmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 16, 2021

First Posted

March 1, 2021

Study Start

March 2, 2021

Primary Completion

December 31, 2023

Study Completion

December 31, 2023

Last Updated

March 4, 2021

Record last verified: 2021-03

Data Sharing

IPD Sharing
Will not share

Locations

TW(1)