Comparative Study Between Acrylic and Flexible Dentures | NCT03184883

Studies
Comparative Study Between Acrylic and Flexible Dentures

NCT03184883

Sponsor

Cairo University

Status

Unknown status

Last Update Posted

Jul 21, 2017Actual

Enrollment

17Estimated

Phase

Not Applicable

Conditions

Health Knowledge, Attitudes, Practice

Interventions

single conventional denture
single flexible denture

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

Jun 2017

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

Sep 1, 2017Estimated

Primary Completion Date

Oct 1, 2017Estimated

Completion Date

Dec 1, 2017Estimated

First Submitted Date

Jun 2, 2017

First Submission Date that Met QC Criteria

Jun 11, 2017

First Posted Date

Jun 14, 2017Actual

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

Jul 19, 2017

Last Update Posted Date

Jul 21, 2017Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Marianne Azer, Comparative Study of Conventional versus Flexible Mandibular Single Complete Denture, Cairo UniversityPrincipal Investigator

Lead Sponsor

Cairo UniversityOTHER

Collaborators

Not provided

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

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

comparing the effect of conventional mandibular single denture with flexible mandibular single denture on tissue and patient's satisfaction

Detailed Description

comparing the effect of conventional mandibular single denture with flexible mandibular single denture on tissue by keratinization index through PAP stain and patient's satisfaction through a questionnaire

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

17Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
single conventional denture	Experimental	patients with mandibular edentulous arch by using acrylic resin denture with soft linner	Procedure: single conventional denture
single flexible denture	Active Comparator	patients with mandibular edentulous arch by using flexible lower denture	Procedure: single flexible denture

Interventions

Name	Type	Description	Arm Group Labels	Other Names
single conventional denture	Procedure	mandibular conventional denture with soft liner	single conventional denture

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Cytological changes manifested as keratinization index	Objective Outcome: measuring the cytological changes manifested as keratinization index	6 months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Mandibular flat ridge
Patient with opposing natural teeth or satisfactory fixed prostheses
Angle class I Maxillimandibular relationship
No intraoral soft and hard tissue pathosis
Non smokers
Patients with no previous denture experience
Patients having last extraction at least 6 month before denture construction

Exclusion Criteria:

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Marianne Azer, Bachelor	Contact	01227243531		marianne.fouad@dentistry.cu.edu.eg
Ahmed Fayad, lecturer	Contact	01005185211

Overall Officials

Name	Affiliation	Role
Essam Aziz, professor	supervisor	Principal Investigator

Locations

Not provided

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D001519	Behavior

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided