Clinical Performance of Self-cured Universal Adhesive for... | NCT05054673

Studies
Clinical Performance of Self-cured Universal Adhesive for Restoring Cervical Lesions in Geriatric Patients

NCT05054673

Sponsor

Cairo University

Status

Unknown status

Last Update Posted

Sep 23, 2021Actual

Enrollment

28Estimated

Phase

Not Applicable

Conditions

Universal Adhesive

Interventions

universal adhesive
universal adhesive

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

Annotation Module

Unposted Annotation

Unposted Responsible Party

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2021

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 2021Estimated

Primary Completion Date

Oct 2022Estimated

Completion Date

Oct 2022Estimated

First Submitted Date

Sep 11, 2021

First Submission Date that Met QC Criteria

Sep 21, 2021

First Posted Date

Sep 23, 2021Actual

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

Sep 21, 2021

Last Update Posted Date

Sep 23, 2021Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

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

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

the study is conducted to evaluate the clinical performance of PALFIQUE universal adhesive (Tokuyama self-cure universal adhesive), Versus 3m ESPE™ single bond Universal Adhesive, for restoring cervical lesions in geriatric patients over one year.

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

28Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
intervention	Experimental	PALFIQUE universal adhesive (Tokuyama self-cure universal adhesive)	Other: universal adhesive
control	Active Comparator	3M™ ESPE™ single bond Universal Adhesive	Other: universal adhesive

Interventions

Name	Type	Description	Arm Group Labels	Other Names
universal adhesive	Other	PALFIQUE universal adhesive	intervention

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Measuring the Marginal adaptation	modified USPHS criteria, ordinal	1 year

Secondary Outcomes

Measure	Description	Time Frame
level of Retention	binary , modified USPHS criteria	1 year
Level of Marginal discoloration	ordinal, modified USPHS criteria	1 year

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

The patient had to be in good general health
Geriatric patients
Have an acceptable oral hygiene level
Class V cavities in anterior and posterior teeth
Males & females included
Anticipated availability for recalls (6 months and 12 months) through the 1-year study period

Exclusion Criteria:

Lack of written informed consent to participate
Poor oral hygiene,
Severe bruxism
Severe or chronic periodontitis
Allergies to components of the materials used
Underage patients
Non vital pulp

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

60 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Maysaa M Mostafa, B.D.S.	Contact	01001422220	002	mayssaa.motafa@dentistry.cu.edu.eg

Overall Officials

Not provided

Locations

Not provided

Type	Date	Date Unknown
Release	Dec 22, 2023
Reset	Jun 13, 2024

Submission Tracking

Estimated Results First Submitted Date

Dec 22, 2023

First MCP Posted Date

Not provided

Submission Infos

Release Date	Unrelease Date	Unrelease Date Unknown	Reset Date	MCP Release Number
Dec 22, 2023			Jun 13, 2024