Clinical Evaluation of Two Low-shrinkage Composites | NCT03708510

Studies
Clinical Evaluation of Two Low-shrinkage Composites

NCT03708510

Sponsor

Hacettepe University

Status

Completed

Last Update Posted

Apr 17, 2024Actual

Enrollment

18Actual

Phase

Not Applicable

Conditions

Tooth Diseases

Interventions

Restorative materials- Filtek Silorane
Restorative materials-Kalore
Preparation-Er,Cr:YSGG Laser
Preparation- Diamond Bur

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2024

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 1, 2011Actual

Primary Completion Date

Sep 1, 2011Actual

Completion Date

Sep 1, 2018Actual

First Submitted Date

Oct 14, 2018

First Submission Date that Met QC Criteria

Oct 14, 2018

First Posted Date

Oct 17, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 16, 2024

Last Update Posted Date

Apr 17, 2024Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Patients with 4 occlusal lesions in molar teeth will be included. Occlusal cavities will be prepared either by Er,Cr:YSGG laser (LS) or conventional diamond bur (BR). Cavities will be restored with Filtek Silorane (3M-ESPE) (SR) and with Kalore (GC) (KR) according to the manufacturers' instructions. All restorative procedures will be performed by one operator and the restorations will be examined by two evaluators according to the FDI (World Dental Federation) criteria at baseline and at 6-month, 1-, 2-,3-, 4-, 5-, 6-, 7-, 8-, 9-, 10-year. Patients' satisfaction about the preparation methods will be evaluated with a survey. Pearson Chi-Square test will be used for statistical analyze(p=0.05).

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

18Actual

Arms/Interventions Module

Arm Groups

Label	Type	Intervention Names
Filtek Silorane-Er,Cr:YSGG Laser	Experimental	Device: Restorative materials- Filtek Silorane Device: Preparation-Er,Cr:YSGG Laser
Filtek Silorane- Diamond Bur	Experimental	Device: Restorative materials- Filtek Silorane Device: Preparation- Diamond Bur
Kalore- Er,Cr:YSGG Laser	Experimental	Device: Restorative materials-Kalore Device: Preparation-Er,Cr:YSGG Laser
Kalore- Diamond Bur	Experimental	Device: Restorative materials-Kalore Device: Preparation- Diamond Bur

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Restorative materials- Filtek Silorane	Device	Filtek Silorane	Filtek Silorane- Diamond Bur Filtek Silorane-Er,Cr:YSGG Laser

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Clinical performance of different low-shrinkage composites and preparations	Evaluations according to FDI criteria	10 years

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

age range will be 18 to 60
patients should have at least 4 occlusal caries lesions require restoration
healty periodontal status
a good likelihood of recall availability

Exclusion Criteria:

poor gingival health
adverse medical history
potential behavioral problems

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

60 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided