Biting Force in Heat Cured Acrylic Resin Versus CAD/CAM M... | NCT02996123

Studies
Biting Force in Heat Cured Acrylic Resin Versus CAD/CAM Maxillary Single Denture Bases

NCT02996123

Sponsor

Cairo University

Status

Unknown status

Last Update Posted

Dec 19, 2016Estimated

Enrollment

63Estimated

Phase

Not Applicable

Conditions

Bites, Human

Interventions

cad/cam maxillary dentures

Countries

Egypt

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

Dec 2016

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Enrolling by invitation

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2016

Primary Completion Date

Nov 2017Estimated

Completion Date

Dec 2017Estimated

First Submitted Date

Dec 12, 2016

First Submission Date that Met QC Criteria

Dec 14, 2016

First Posted Date

Dec 19, 2016Estimated

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

Dec 14, 2016

Last Update Posted Date

Dec 19, 2016Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

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

measuring difference in biting force between (computer aided design/computer aided manufacturing) maxillary dentures and conventional ones.

Detailed Description

measuring difference in biting force using i-load device with followup period of 6 months

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

63Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
cad/cam maxillary dentures	Experimental	single maxillary dentures fabricated by cad/cam method	Other: cad/cam maxillary dentures
conventional dentures	Active Comparator	heat cured single maxillary dentures	Other: cad/cam maxillary dentures

Interventions

Name	Type	Description	Arm Group Labels	Other Names
cad/cam maxillary dentures	Other	patients wearing cad/cam designed and milled dentures	cad/cam maxillary dentures conventional dentures

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Biting Force in Heat Cured acrylic resin versus CAD/CAM Maxillary Single Denture Bases		6 month

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients with completely edentulous maxillary ridge with minimum undercuts, opposing a partially edentulous ridge.
Mean age of 50-75 years of age.
The edentulous ridges should be covered by firm healthy mucosa.
Systemically free; no history of diabetes, chemotherapy, and radiotherapy.
Co-operative patients.

Exclusion Criteria:

Patients with severely resorbed maxillary ridge
Previous history of radiotherapy or chemotherapy.
Patients with xerostomia
Patients with neuromuscular and hormonal disorders
Patients with severe bony or soft tissue undercuts
Patients with large tongue
Patients with limited mouth opening
Patients with known history of allergy, especially to acrylic resin

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

50 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Cairo university		Cairo Governorate			Egypt

IPD Sharing Statement Module

Plan to Share IPD

Yes

Description

charts with measurements and readings collected will be recorded and available

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D001734	Bites, Human

Ancestor Terms

ID	Term
D001733	Bites and Stings
D014947	Wounds and Injuries

Browse Leaves

Not provided

Browse Branches

Not provided