Patient Centered Outcomes and Marginal Bone Changes in CA... | NCT05622448

Studies
Patient Centered Outcomes and Marginal Bone Changes in CAD/CAM Metallic and (PEEK) Partial Denture Frameworks

NCT05622448

Sponsor

Cairo University

Status

Completed

Last Update Posted

Feb 5, 2025Actual

Enrollment

30Actual

Phase

Not Applicable

Conditions

Patient Satisfaction

Interventions

RPD with PEEK framework
RPD with metallic framework

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

Oct 1, 2019Actual

Primary Completion Date

Jun 1, 2022Actual

Completion Date

Dec 30, 2023Actual

First Submitted Date

Jul 18, 2019

First Submission Date that Met QC Criteria

Nov 14, 2022

First Posted Date

Nov 18, 2022Actual

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

Feb 1, 2025

Last Update Posted Date

Feb 5, 2025Actual

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

FDAAA801 Violation

Not provided

Description Module

Brief Summary

To compare PEEK to metallic partial denture frameworks in restoring mandibular Kennedy class I regarding patient satisfaction.

Detailed Description

The traditional RPDs with cobalt chromium frameworks and clasps have been proven to be inexpensive, accurate, durable and resistant to distortion .2 On the other hand, they have; unesthetic display of metallic clasps, increased weight, and may provoke an allergic reaction. Because of those drawbacks new metal-free materials have been reported as a replacement of metal alloys in manufacturing RPDs, including; high performance polymers such as polyethylene glycol, polyetherketonketon (PEKK), polyaryletherketone (PAEK) and Polyetheretherketon (PEEK).

Using PEEK and modified PEEK (BioHPP) frameworks were claimed to reduce the distal torqueing and stresses on the abutments in kennedy class I PPDs which is thought to be beneficial for periodontal health of the abutments.10 One of the factors for the dissatisfaction related to the dentures may be attributed to the level of oral perception of each patient. The satisfaction level of the patient is influenced by several factors, including the dentures quality and the plated area, the quality of interaction in the patient-dentist relationship, past experiences with full dentures, and the psychological personality6. In harmony, such factors may promote the improvement of the mastication, the speech, and the aesthetics of the teeth, besides producing less discomfort and pain sensitivity, favoring the comminution of harder food7. However, there are no clinical trials evaluating the effect of PEEK on patient satisfaction and the marginal bone loss around the 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

30Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
RPD with metallic framework	Active Comparator	removable partial denture with cobalt chromium framework	Other: RPD with PEEK framework Other: RPD with metallic framework
RPD with PEEK framework	Experimental	removable partial denture with poly ether ether ketone framework	Other: RPD with PEEK framework Other: RPD with metallic framework

Interventions

Name	Type	Description	Arm Group Labels	Other Names
RPD with PEEK framework	Other	removable partial denture with CAD designed PEEK framework	RPD with PEEK framework RPD with metallic framework

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
patient satisfaction	Patient satisfaction will be measured using a valid and reliable questionnaire which is Patient satisfaction with lower removable denture questionnaire SLRD-Q. likert scale ranges from very good (1) to good (2), neither good nor bad (3), bad (4), and extremely bad (5)	From enrollment to the last follow up
Oral Health Related quality of life		From enrollment to the last follow up

Secondary Outcomes

Measure	Description	Time Frame
Marginal bone changes.	Radiographic follow up will be performed for marginal bone changes.	2 years

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients with bilateral free end saddles in the mandible (kennedy class I) with last standing abutment premolar.
Opposing dentition is fully intact or restored.
Sufficient inter-arch space.
Angle's class I maxilla-mandibular relationship.

Exclusion Criteria:

Periodontal affection of the abutment teeth.
Skeletal mal-relation.
Unmotivated patients to maintain adequate oral hygiene to follow up.
Patients with neuromuscular and Psychiatric disorders.
Systematic disease affecting bone and periodontal health.
Insufficient inter-arch space.
Patients with physical reasons that could affect follow up.

Accepts Healthy Volunteers

Yes

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

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Faculty of Dentistry		Cairo		1234	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
D017060	Patient Satisfaction

Ancestor Terms

ID	Term
D000074822	Treatment Adherence and Compliance
D015438	Health Behavior
D001519	Behavior

Browse Leaves

Not provided

Browse Branches

Not provided