Marginal Bone Height Changes Around Two Different Surface... | NCT04800406

Studies
Marginal Bone Height Changes Around Two Different Surface Treated Dental Implants Supporting Mandibular Complete Overdenture.

NCT04800406

Sponsor

National Research Centre, Egypt

Status

Completed

Last Update Posted

Mar 16, 2021Actual

Enrollment

10Actual

Phase

Not Applicable

Conditions

Assess Marginal Bone Height Changes Around Dental Implants

Interventions

Dental Implants

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

Mar 2021

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

Jan 1, 2018Actual

Primary Completion Date

Jan 1, 2019Actual

Completion Date

Jan 1, 2019Actual

First Submitted Date

Mar 13, 2021

First Submission Date that Met QC Criteria

Mar 13, 2021

First Posted Date

Mar 16, 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

Mar 13, 2021

Last Update Posted Date

Mar 16, 2021Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Asmaa Nabil Elboraey, Associate Professor, National Research Centre, EgyptPrincipal Investigator

Lead Sponsor

National Research Centre, EgyptOTHER

Collaborators

Not provided

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

Patients participating in this study were rehabilitated by mucosa supported maxillary complete denture and mandibular overdenture supported by two different surface treated implants; resorbable blast media (RBM) on the right and Acid etched on the left; retained by ball attachments. The marginal bone height changes around RBM and acid etched surface treated dental implants retaining mandibular complete overdenture were assessed by cone beam computed tomography.

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

10Actual

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Dental Implants	Procedure	Resorbable blast media surface treated dental implant and Acid etched surface treated dental implant.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Marginal Bone height changes	The marginal bone changes around each type of dental implant were assessed by cone beam computed tomography.	one year

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Free from any systemic diseases affecting the bone metabolism.
Healthy, firm covering mucosa which is free from any signs of Inflammation or ulceration.
Residual alveolar ridge with adequate height and width.
Angel's class I classification maxillo - mandibular relationship.
Sufficient inter arch space

Exclusion Criteria:

Smoker.
Patients with parafunction habits (clenching or bruxism).

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

50 Years

Maximum Age

60 Years

Standard Ages

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
National Research Centre		Cairo	Dokki	12622	Egypt

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D015921	Dental Implants

Ancestor Terms

ID	Term
D003764	Dental Materials
D001697	Biomedical and Dental Materials
D017266	Dental Prosthesis
D011476	Prosthodontics

Browse Leaves

Not provided

Browse Branches

Not provided