3D -Printed Single Implant Overdentures | NCT04366895

Studies
3D -Printed Single Implant Overdentures

NCT04366895

Sponsor

October University for Modern Sciences and Arts

Status

Completed

Last Update Posted

Nov 9, 2022Actual

Enrollment

28Actual

Phase

Not Applicable

Conditions

Edentulous Mouth

Interventions

conventional single implant overdenture
3d printed single implant overdenture

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

Nov 2022

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 20, 2021Actual

Primary Completion Date

Jun 20, 2022Actual

Completion Date

Aug 21, 2022Actual

First Submitted Date

Apr 21, 2020

First Submission Date that Met QC Criteria

Apr 25, 2020

First Posted Date

Apr 29, 2020Actual

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

Nov 6, 2022

Last Update Posted Date

Nov 9, 2022Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Dina ElAwady, lecturer of Prosthodontics (principal investigator), October University for Modern Sciences and ArtsPrincipal Investigator

Lead Sponsor

October University for Modern Sciences and ArtsOTHER

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

A randomized clinical trial (RCT) was designed. The participants were randomly allocated into either of the two groups intervention or control group each of 14 participants. Participants in control group (Group-A) received conventional manufactured implant overdenture while participants in intervention group (Group-B) received CAD-CAM manufactured implant overdenture.

Detailed Description

Introduction: Mandibular single implant overdenture is a well-established treatment modality that address limited financial resources of patients and simultaneously enabled the management of conventional complete denture problems. CAD/CAM technology helped to mitigate the problems encountered with conventional fabrication techniques, which results in improved dentures fit and retention. Therefore, the aim of the current trial study was to evaluate whether overdentures fabricated using CAD/CAM printed technology exhibited improved patient satisfaction, denture retention, implant survival rate and decreased post-insertion maintenance or not compared to overdentures manufactured using conventional techniques.

Methods: A randomized clinical trial (RCT) was designed. The participants were randomly allocated into either of the two groups intervention or control group each of seven participants. Participants in control group (Group-A) received conventional manufactured implant overdenture while participants in intervention group (Group-B) received CAD-CAM manufactured implant overdenture.

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

28Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
control	Experimental	Participants in control group (Group-A) received conventional manufactured implant overdenture	Other: conventional single implant overdenture
intervention	Experimental	participants in intervention group (Group-B) received CAD-CAM manufactured implant overdenture.	Other: 3d printed single implant overdenture

Interventions

Name	Type	Description	Arm Group Labels	Other Names
conventional single implant overdenture	Other	conventional manufactured implant overdenture	control

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Implant survival	The implants were considered surviving if they were clinically stable, functioning without any mobility	1 year

Secondary Outcomes

Measure	Description	Time Frame
Survival rate of overdentures	urvival rate of overdentures: (calculated by Incidence of mid-line fracture)	1 year
maximum biting force (MBF)	MBF was achieved bilaterally using Flexiforce A 301® force sensor and Arduino microcontroller with a crystal displa

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

inclusion criteria

the participant should be completely edentulous ranging in age from 35 to 75 years
Angle's class I skeletal relationship
normal facial symmetry
adequate inter-arch space not less than 12mm
should be a cooperative patient -

Exclusion Criteria:

temporomandibular disorders
uncontrolled diabetes
bleeding disorders or anticoagulant therapy
flabby tissues or sharp mandibular residual ridge
neuromuscular disorders
Angle's class II and III skeletal relationship.
Patients who were heavy smokers
chemotherapy or radiotherapy or with severe psychiatric disorders

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

35 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

Name	Affiliation	Role
Dina Elawady, PHD	Lecturer	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Msa Uni		Giza		12451	Egypt

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
D009066	Mouth, Edentulous

Ancestor Terms

ID	Term
D009059	Mouth Diseases
D009057	Stomatognathic Diseases
D014076	Tooth Diseases

Browse Leaves

Not provided

Browse Branches

Not provided