Unilateral Attachment Versus Tooth Implant Supported Bridge | NCT04301115

Studies
Unilateral Attachment Versus Tooth Implant Supported Bridge

NCT04301115

Sponsor

Cairo University

Status

Completed

Last Update Posted

Mar 10, 2020Actual

Enrollment

24Actual

Phase

Not Applicable

Conditions

Edentulous Jaw

Interventions

attachment
bridge
CONVENTIONAL

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 2020

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

Feb 1, 2018Actual

Primary Completion Date

Sep 20, 2019Actual

Completion Date

Oct 1, 2019Actual

First Submitted Date

Mar 2, 2020

First Submission Date that Met QC Criteria

Mar 6, 2020

First Posted Date

Mar 10, 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

Mar 6, 2020

Last Update Posted Date

Mar 10, 2020Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Sharaf Mohamed Yahia, lecturer of prosthodontics, 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

Purpose: Evaluation of patients' satisfaction, biting force measurement and radiographic evaluation of abutment teeth of tooth implant supported bridge, unilateral attachment and conventional partial denture in mandibular distal extension cases.

Materials and methods: Twenty four patients were selected and divided into three equal groups, each of eight patients: patients of group I Patients received a fixed tooth implant supported bridge, patients of group II Patients received a removable unilateral attachment partial denture and group III Patients received a conventional removable partial denture.Evaluation included patient satisfaction and biting force measurement radiographic evaluation of terminal abutments.

Detailed Description

Materials and methods: Twenty four patients were selected according to the following criteria: Patients with unilateral mandibular distal extension with last standing second premolar abutment, abutments showed sufficient occluso-gingival height and good periodontal condition. Patients were divided into three equal groups, each of eight patients: patients of group I Patients received a fixed tooth implant supported bridge, patients of group II Patients received a removable unilateral attachment partial denture and group III Patients received a conventional removable partial denture.Evaluation included patient satisfaction using "OHIP14" questionnaires and biting force measurement radiographic evaluation of terminal abutments.

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

24Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
conventional group	Active Comparator	conventional partial denture	Other: CONVENTIONAL
attachment group	Experimental	unlateral attachment retained partial denture	Other: attachment
tooth implant supporeted prosthesis	Experimental	tooth implant supported bridge	Other: bridge

Interventions

Name	Type	Description	Arm Group Labels	Other Names
attachment	Other	unilateral attachment from rehine 83	attachment group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
patient satisfaction	questionnaires	1 month

Secondary Outcomes

Measure	Description	Time Frame
biting force	measuring the biting force of the patients by sensor	1 month
radiographic evaluation	evaluation of alveolar bone loss

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Unilateral mandibular distal extension area
The abutments showed sufficient occluso-gingival height of its clinical crown
Adequate inter-arch space and no tempro-mandibular joint disorders.
No para-functional habits,
Full opposing arch or restored with acceptable fixed restoration
Minimal bone height11 mm at the lower second molar area.

Exclusion Criteria:

*Insufficent bone height in posterior area of mandible

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

Not provided

Overall Officials

Name	Affiliation	Role
samira Ibrahim, prof	professor of prosthodontics	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Cairo University		Cairo		11511	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
D007575	Jaw, Edentulous
D017060	Patient Satisfaction

Ancestor Terms

ID	Term
D007571	Jaw Diseases
D009140	Musculoskeletal Diseases
D009057	Stomatognathic Diseases
D009066	Mouth, Edentulous

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D003226	Congresses as Topic
D003829	Denture, Partial

Ancestor Terms

ID	Term
D009938	Organizations
D004472	Health Care Economics and Organizations
D003778	Dentures
D017266	Dental Prosthesis

Browse Leaves

Not provided

Browse Branches

Not provided